AIAG-Production part approval process(PPAP)

Production Part Approval Process (PPAP) defines generic requirements for production part approval, including production and bulk materials. The purpose of PPAP is to determine if all customer engineering design record and specification requirements are properly understood by the organization and that the manufacturing process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rates.

PPAP shall apply to internal and external organization sites supplying production parts, service parts, production materials, or bulk materials. For bulk materials, PPAP is not required unless speciﬁed by the authorized customer representative. An organization supplying standard catalog production or service parts shall comply with PPAP unless formally waived by the authorized customer representative.
NOTE: See customer-speciﬁc requirements for additional information. All questions about PPAP
should be addressed to the authorized customer representative. A customer can formally waive PPAP requirements for an organization. Such waivers can only be issued by an authorized customer representative. An organization or supplier requesting a waiver of a PPAP requirement should contact the authorized customer representative. The organization or supplier should obtain documentation of waivers from the authorized customer representative. Catalog parts (e.g., bolts) are identiﬁed and/or ordered by functional speciﬁcations or by recognized industry standards.

Section 1: General

Submission of PPAP

The organization shall obtain approval from the authorized customer representative for:

a new part or product (e.g., a speciﬁc part, material, or color not previously supplied to the
speciﬁc customer).
correction of a discrepancy on a previously submitted part.
product modiﬁed by an engineering change to design records, speciﬁcations, or materials

NOTE: If there is any question concerning the need for production part approval, contact the authorized customer representative.

Section 2 — PPAP Process Requirements

2.1 Significant Production Run

For production parts, product for PPAP shall be taken from a signiﬁcant production run. This signiﬁcant production run shall be from one hour to eight hours of production, and with the speciﬁc production quantity to total a minimum of 300 consecutive parts, unless otherwise speciﬁed by the authorized customer representative. This signiﬁcant production run shall be conducted at the production site, at the production rate using the production tooling, production gaging, production process, production materials, and production operators. Parts from each unique production process, e.g., duplicate assembly line and/or Work. cell, each position of a multiple cavity die, mold, tool or pattern, shall be measured and representative parts tested.

For Bulk materials: No speciﬁc number of “parts” is required. The submitted sample shall be taken in a manner as to assure that it represents “steady-state” operation of the process.
NOTE: For bulk material, production histories of current products may often be used to estimate the initial process capability or performance of new and similar products. In cases where no production history of a similar bulk material product or technology exists, a containment plan may be put into effect until sufﬁcient production has demonstrated capability or performance, unless otherwise speciﬁed by the customer.

2.2 PPAP Requirements

The organization shall meet all speciﬁed PPAP requirements listed below and also meet all customer-speciﬁc PPAP requirements. Production parts shall meet all customer engineering design record and speciﬁcation requirements including safety and regulatory requirements. Bulk Material PPAP requirements are deﬁned by a completed Bulk Material Requirements Checklist . If any part speciﬁcations cannot be met, the organization shall document their problem-solving efforts and shall contact the authorized customer representative for concurrence in determination of appropriate corrective action.
NOTE: Items or records may not necessarily apply to every customer part number from every organization. For example, some parts do not have appearance requirements, others do not have color requirements, and plastic parts may have polymeric part marking requirements. In order to determine with certainty which items must be included, consult the design record, e.g., part print, the relevant Engineering documents or speciﬁcations, and your authorized customer representative.

1. Design Record

The organization shall have the design record for the saleable product/part, including design records for components or details of the saleable product/part. Where the design record is in electronic format, e.g., CAD/CAM math data, the organization shall produce a hard copy (e. g., pictorial, geometric dimensioning & tolerancing [GD&T] sheets, drawing) to identity measurements taken.
NOTE : For any saleable product, part or component, there will only be one design record, regardless of who has design—responsibility. The design record may reference other documents making them part of the design record. A single design record can represent multiple part or assembly conﬁgurations, e. g., a sub-frame assembly with various hole configurations for different applications. For parts identiﬁed as black box , the design record speciﬁes the interface and performance requirements. For parts identified as catalog parts, the design record may consist only of a functional speciﬁcation or a reference to a recognized industry standard. For bulk materials, the design record may include identiﬁcation of raw materials, formulations, processing steps and parameters, and ﬁnal product specifications or acceptance criteria. If dimensional results do not apply, then CAD/CAM requirements are also not applicable.

a) Reporting of Part Material Composition

The organization shall provide evidence that the Material/Substance Composition reporting that is required by the customer has been completed for the part and that the reported data complies with all customer—speciﬁc requirements
NOTE: This materials reporting may be entered into the IMDS (International Materials Data System) or – other customer-speciﬁed system/method. IMDS is available through http://www.mdsystem.com/index.jsp.

b) Marking of Polymeric Parts

Where applicable, the organization shall identify polymeric parts with the ISO symbols such as speciﬁed in ISO 11469, “Plastics-Generic Identiﬁcation and marking of plastic products” and/or ISO 1629, “Rubber and lattices-Nomenclature.” The following weight criteria shall determine if the marking requirement is applicable:

Plastic parts weighing at least 100g (using ISO 11469/1043-1)
Elastomeric parts weighing at least 200g (using ISO 11469/ 1629)

NOTE: Nomenclature and abbreviation references to support the use of ISO 11469 are contained in ISO 1043-1 for basic polymers and in ISO 1043-2 for ﬁllers and reinforcements.

2. Authorized Engineering Change documents

The organization shall have any authorized engineering change documents for those changes not yet recorded in the design record but incorporated in the product, part or tooling.

3 Customer Engineering Approval

Where speciﬁed by the customer, the organization shall have evidence of customer engineering approval.
NOTE: For bulk materials, this requirement is satisﬁed by a signed ‘Engineering Approval” line item on the Bulk Material Requirements Checklist and/or inclusion on a customer maintained list
of approved materials.

4 Design Failure Mode and Effects Analysis (Design FMEA)- if the organization is product design-responsible

The product design-responsible organization shall develop a Design FMEA in accordance with, and compliant to, customer-speciﬁed requirements (e.g., Potential Failure Mode and Effects Analysis reference manual).
NOTE : A single Design FMEA may be applied to a family of similar parts or materials.

5 Process Flow Diagram

The organization shall have a process ﬂow diagram in an organization—speciﬁed format that clearly describes the production process steps and sequence, as appropriate, and meets the speciﬁed customer needs, requirements and expectations (e.g., Advanced Product Quality Planning and Control Plan reference manual). For bulk materials, an equivalent to a Process Flow Diagram is a Process Flow Description.
NOTE: Process flow diagrams for ‘families’ of similar parts are acceptable if the new parts have been reviewed for commonality by the organization.

6 Process Failure Mode and Effects Analysis (Process FMEA)

The organization shall develop a Process FMEA in accordance with, and compliant to, customer-speciﬁed requirements, (e.g., Potential Failure Mode and Effects Analysis reference manual).

NOTE : A single Process FMEA may be applied to a process manufacturing a family of similar parts or materials if reviewed for commonality by the organization.

7 Control Plan

The organization shall have a Control Plan that deﬁnes all methods used for process control and complies with customer-speciﬁed requirements (e.g., Advanced Product Quality Planning and Control Plan reference manual).
NOTE : Control Plans for “families” of parts are acceptable if the new parts have been reviewed for commonality by the organization. Control Plan approval may be required by certain customers.

8 Measurement System Analysis Studies

The organization shall have applicable Measurement System Analysis studies, e.g., gage R&R, bias, linearity, stability, for all new or modified gages, measurement, and test equipment.
NOTE : Gage R&R acceptability criteria are deﬁned in the Measurement Systems Analysis reference manual. For bulk materials, Measurement System Analysis may not apply. Customer agreement should be obtained on actual requirements.

9 Dimensional Results

The organization shall provide evidence that dimensional verification required by the design record and the Control Plan have been completed and results indicate compliance with speciﬁed requirements. The organization shall have dimensional results for each unique manufacturing process, e.g., cells or production lines and all cavities, molds, patterns or dies . The organization shall record, with the actual results: all dimensions (except reference dimensions), characteristics, and speciﬁcations as noted on the design record and Control Plan. The organization shall. indicate the date of the design record, change level, and any authorized engineering change document not yet incorporated in the design record to which the part was made. The organization shall record the change level, drawing date, organization name and part number-on all auxiliary documents (e.g., supplementary layout results sheets, sketches, tracings, cross sections, CMM inspection point results, geometric dimensioning and tolerancing sheets, or other auxiliary drawings used in conjunction with the part drawing). Copies of these auxiliary materials shall accompany the dimensional results according to the Retention] Submission Requirements Table. A tracing shall be included when an optical comparator is necessary for inspection. The organization shall identify one of the parts measured as the master sample.
NOTE: The Dimensional Results form , a pictorial, geometric dimensioning & tolerancing [GD&T] sheets, or a checked print Where the results are legibly written on a part drawing including cross-sections, tracings, or sketches as applicable may be utilized for this purpose. Dimensional results typically do not apply to bulk materials.

10 Records of Material / Performance Test Results

The organization shall have records of material and/or performance test results for tests speciﬁed on the design record or Control Plan.
Material Test Results
The organization shall perform tests for all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or Control Plan. Material test results shall indicate and include:

the design record change level of the parts tested;
any authorized engineering change documents that have not yet been incorporated in the
design record;
the number, date, and change level of the speciﬁcations to which the part was tested;
the date on which the testing took place;
the quantity tested;
the actual results; .
the material supplier’s name and, when required by the customer, the customer—assigned supplier/vendor code.

NOTE: Material test results may be presented in any convenient format.

For products with customer-developed material speciﬁcations and a customer-approved supplier list, the organization shall procure materials and/or services (e.g., painting, plating, heat-treating, welding) from suppliers on that list.

Performance Test Results

The organization shall perform tests for all part(s) or product material(s) when performance or functional requirements are specified by the design record or Control Plan. Performance test results shall indicate and include:

the design record change level of the parts tested;
any authorized engineering change documents that have not yet been incorporated in the design record;
the number, date, and change level of the speciﬁcations to which the part was tested;
the date on which the testing took place;
the quantity tested;
the actual results.

NOTE: Performance test results may be presented in any convenient format.

11. Initial Process Studies

a) General

The level of initial process capability or performance shall be determined to be acceptable prior to submission for all Special Characteristics designated by the customer or organization. The Organization shall obtain customer concurrence on the index for estimating initial process _ capability prior to submission. The organization shall perform measurement system analysis to understand how measurement error affects the study measurements.
NOTE : Where no special characteristics have been identiﬁed, the customer reserves the right to require demonstration of initial process capability on other characteristics. The purpose of this requirement is to determine if the production process is likely to produce product that will meet the customer’s requirements. The initial process study is focused on variables not. attribute data. Assembly errors, test failures, surface defects are examples of attribute data, which is important to understand, but is not covered in this initial study. To understand the performance of characteristics monitored by attribute data will require more data collected over time. Unless approved by the authorized customer representative, attribute data are not acceptable for PPAP submissions. C_pk and P_pk are described below. Other methods more appropriate for certain processes or products may be substituted with prior approval from an authorized customer representative. Initial process studies are short-term and will not predict the effects of time and variation in people, materials, methods, equipment, measurement systems, and environment. Even for these short-term studies, it is important to collect and analyze the data in the order produced using control charts. For those characteristics that can be studied using X-bar and R charts, a short-term study should be based on a minimum of 25 subgroups containing at least 100 readings from consecutive parts of the significant production run. The initial process study data requirements may be replaced by longer-term historical data from the same or similar processes, with customer concurrence. For certain processes, alternative analytical tools such as individual and moving range charts may be appropriate and permitted with prior approval from an authorized customer representative.

b) Quality Indices
Initial process studies shall be summarized with capability or performance indices, if applicable.
NOTE: The initial process study results are dependent on the purpose of the study, method of data acquisition, sampling, amount of data, demonstration of statistical control, etc.For guidance on items listed below, contact the authorized customer representative.
C_pk– The capability index for a stable process. The estimate of sigma is based on within subgroup
variation (R-bar/d₂ or S-bar/c₄). C_pk an indicator of process capability based on process variation within each subgroup of a set of data. C_pk, does not include the effect of process variability between the subgroups. C_pk is an indicator of how good a process could be if all process variation between subgroups was to be eliminated. Therefore, use of C_pk alone may be an incomplete indicator of process performance.
P_pk– The performance index. The estimate of sigma is based on total variation (all of individual sample data using the standard deviation [root mean square equation], “s”). P_pk is an indicator of process performance based on process variation throughout the full set of data. Unlike C_pk, P_pk is not limited to the variation within subgroups. However, P_pk cannot isolate within subgroup variation from between subgroup variation. When calculated from the same data set, C_pk and P_pk can be compared to analyze the sources of process variation.
Initial Process Studies. The purpose of the initial process study is to understand the process variation, not just to achieve a specific index value. When historical data are available or enough initial data exist to plot a control chart (at least 100 individual samples), C_pk can be calculated when the process is stable. Otherwise, for processes with known and predictable special causes and output meeting specifications, P_pk should be used. When not enough data are available (< 100 samples) or there are unknown sources of variation, contact the authorized customer representative to develop a suitable plan.
For Initial Process Studies involving more than one process stream, additional appropriate statistical methods or approaches may be required. For bulk material, the organization should obtain customer agreement regarding the appropriate techniques for initial process studies, if required, in order to determine an effective estimate of capability.

c) Acceptance Criteria for Initial Study

The organization shall use the following as acceptance criteria for evaluating initial process study results for processes that appear stable.

Results	Interpretation
Index > 1.67	The process currently meets the acceptance criteria.
1.33 3≤ Index≤ 1.67	The process may be acceptable. Contact the authorized customer representative for a review of the study results.
Index < 1.33	The process does not currently meet the acceptance criteria. Contact the authorized customer representative for a review of the study results.

NOTE : Meeting the initial process study capability acceptance criteria is one of a number of customer requirements that leads to an approved PPAP submission.

d) Unstable Processes
Depending on the nature of the instability, an unstable process may not meet customer requirements. The organization shall identify, evaluate and, wherever possible, eliminate special causes of variation prior to PPAP submission. The organization shall notify the authorized customer representative of any unstable processes that exist and shall submit a corrective action plan to the customer prior to any submission.
NOTE: For bulk materials, for processes with known and predictable special causes and output meeting speciﬁcations, corrective action plans may not be required by the customer.

e) Processes With One-Sided Speciﬁcations or Non-Normal Distributions
The organization shall determine with the authorized customer representative alternative acceptance criteria for processes with one-sided speciﬁcations or non-normal distributions.
NOTE: The above mentioned acceptance criteria assume normality and a two-sided Speciﬁcation (target in the center). When this is not true, using this analysis may result in unreliable information. These alternate acceptance criteria could require a different type of index or some method of transformation of the data. The focus should be on understanding the reasons for the non-normality (e. g., is it stable over time?) and managing variation.

f) Actions To Be Taken When Acceptance Criteria Are Not Satisﬁed
The organization shall contact the authorized customer representative if the acceptance criteria cannot be attained by the required PPAP submission date. The organization shall submit to the authorized customer representative for approval a corrective action plan and a modiﬁed Control Plan normally providing for 100% inspection. Variation reduction efforts shall continue until the acceptance criteria are met, or until customer approval is received.
NOTE : 100% inspection methodologies are subject to review and concurrence by the customer. For bulk materials, 100% inspection means an evaluation of a sample(s) of product from a continuous process or homogeneous batch which is representative of the entire production run.

12 Qualiﬁed Laboratory Documentation

Inspection and testing for PPAP shall be performed by a qualiﬁed laboratory as deﬁned by customer requirements (e.g., an accredited laboratory). The qualiﬁed laboratory (internal or external to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualiﬁed for the type of measurements or tests conducted. When an external/commercial laboratory is used, the organization shall submit the test results on the laboratory letterhead or the normal laboratory report format. The name of the laboratory that performed the tests, the date of the tests, and the standards used to run the tests shall be identiﬁed.

13 Appearance Approval Report (AAR)

A separate Appearance Approval Report (AAR) shall be completed for each part or series of parts if the product/part has appearance requirements on the design record. Upon satisfactory completion of all required criteria, the organization shall record the required information on the AAR. The completed AAR and representative production products/parts shall be submitted to the location speciﬁed by the customer to receive disposition. AARs (complete with part disposition and authorized customer representative signature) shall then accompany the PSW at the time of ﬁnal submission based upon the submission level requested. See customer-speciﬁc requirements for any additional requirements.
NOTE: AAR typically applies only for parts with color, grain, or surface appearance requirements. Certain customers may not require entries in all AAR ﬁelds.

14 Sample Production Parts

The organization shall provide sample product as speciﬁed by the customer.

15 Master Sample

The organization shall retain a master sample for the same period as the production part approval records, or a) until a new master sample is produced for the same customer part number for customer approval, or b) where a master sample is required by the design record, Control Plan or inspection criteria, as a reference or standard. The master sample shall be identiﬁed as such, and shall show the customer approval date on the sample. The organization shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern, or production process unless otherwise speciﬁed by the customer.
NOTE: When part size, sheer volume of parts, etc. makes storage of a master sample difﬁcult, the
sample retention requirements may be modiﬁed or waived in writing by the authorized customer
representative. The purpose of the master sample is to assist in deﬁning the production standard, especially where data is ambiguous or in insufﬁcient detail to fully replicate the part to its original approved state. Many bulk material properties are by their nature time dependent, and if a master sample is required, it may consist of the manufacturing record, test results, and certiﬁcate of analysis of key ingredients, for the approved submission sample.

16 Checking Aids

If requested by the customer, the organization shall submit with the PPAP submission any part-speciﬁc assembly or component checking aid. The organization shall certify that all aspects of the checking aid agree with part dimensional requirements. The organization shall document all released engineering design changes that have been incorporated in the checking aid at the time of submission. The organization shall provide for preventive maintenance of any checking aids for the life of the part . Measurement system analysis studies, e. g., gage R & R, accuracy, bias, linearity, stability studies, shall be conducted in compliance with customer requirements.
NOTE: Checking aids can include ﬁxtures, variable and attribute gages, models, templates, mylars
speciﬁc to the product being submitted. Checking aids, etc. typically do not apply to Bulk Materials. If checking aids are used for bulk materials, the organization should contact the authorized customer representative regarding this requirement.

17 Customer-Speciﬁc Requirements

The organization shall have records of compliance to all applicable customer-speciﬁc requirements. For bulk materials, applicable customer-speciﬁc requirements shall be documented on the Bulk Material Requirements Checklist.

18 Part Submission Warrant (PSW)

Upon completion of all PPAP requirements, the organization shall complete the Part Submission Warrant (PSW). A separate PSW shall be completed for each customer part number unless otherwise agreed to by the authorized customer representative. If production parts will be produced from more than one cavity, mold, tool, die, pattern, or production process, e. g., line or cell, the organization shall complete a dimensional evaluation on one part from each. The speciﬁc cavities, molds, line, etc., shall then be identiﬁed in the “Mold/Cavity/Production Process” line on a PSW, or in a PSW attachment. The organization shall verify that all of the measurement and test results show conformance with customer requirements and that all required documentation is available and, for Level 2, 3, and 4, is included in the submission as appropriate. A responsible ofﬁcial of the organization shall approve the PSW and provide contact information.
NOTE: One warrant per customer part number can be used to summarize many changes providing that the changes are adequately documented, and the submission is in compliance with customer program timing requirements. PSWs may be submitted electronically in compliance with customer requirements.

a) Part Weight (Mass)
The organization shall record on the PSW the part weight of the part as shipped, measured and expressed in kilograms to four decimal places (0.0000) unless otherwise speciﬁed by the customer. The weight shall not include shipping protectors, assembly aides, or packaging materials. To determine part weight, the organization shall individually weigh ten randomly selected parts, calculate and report the average weight. At least one part shall be measured rom each cavity, tool, line or process to be used in product realization. ‘
NOTE: This weight is used for vehicle weight analysis only and does not affect the approval process. Where there is no production or service requirement for at least ten parts, the organization should use the required number for calculation of the average part weight. For bulk materials, the part weight ﬁeld is not applicable.

Section 3-Customer Notification And Submission Requirements

3.1 Customer Notification

The organization shall notify the authorized customer representative of any planned changes to the design, process, or site. Examples are indicated in the table below .
NOTE: Organizations are responsible to notify the authorized customer representative of all changes to the part design and/or the manufacturing process. Upon notification and approval of the proposed change by the authorized customer representative, and after change implementation, PPAP submission is required unless otherwise speciﬁed.

Examples of changes requiring notiﬁcation	Clariﬁcations
Use of other construction or material than was used in the previously approved part or product	For example, other construction as documented on a deviation (permit) or included as a note on the design record and not covered by an engineering change
Production from new or modiﬁed tools (except perishable tools), dies, molds patterns, etc. including additional or replacement tooling	This requirement only applies to tools, which due to their unique form or function, can be expected to inﬂuence the integrity of the ﬁnal product. It is not meant to describe standard tools (new or repaired), such as standard measuring devices, drivers (manual or power), etc.
Production following upgrade or rearrangement of existing tooling or equipment.	Upgrade means the reconstruction and/or modiﬁcation of a tool or machine or to increase the capacity, performance, or change its existing function. This is not meant to be confused with normal maintenance, repair or replacement of parts, etc., for which no change in performance is to be expected and post repair veriﬁcation methods have been established. Rearrangement is defined as activity that changes the sequence of product/process ﬂow from that documented in the process ﬂow diagram (including the addition of a new process). Minor adjustments of production equipment may be required to meet safety requirements such as, installation of protective covers, elimination of potential ESD risks, etc.
Production from tooling and equipment transferred to a different plant site or from an additional plant site.	Production process tooling and /or equipment transferred between buildings or facilities at one or more sites.
Change of supplier for parts, non-equivalent materials, or services (e. g., heat-treating, plating).	The organization is responsible for approval of supplier provided material and services.
Product produced after the tooling has been inactive for volume production for twelve months or more.	For product that has been produced after tooling has been inactive for twelve months or more: Notification is required when the part has had no change in active purchase order and the existing tooling has been inactive for volume production for twelve months or more. The only exception is when the part has low volume, e.g., service or specialty vehicles. However a customer may specify certain PPAP requirements for service parts.
Product and process changes related to components of the production product manufactured internally or manufactured by suppliers.	Any changes, including changes at the suppliers to the organization and their suppliers, that affect customer requirements, e.g., fit, form, function, performance, durability.
Change in test/inspection method – new technique (no effect on acceptance criteria)	For change in test method, the organization should have evidence that the new method has measurement capability equivalent to the old method.
Additionally, for bulk materials: a) New source of raw material from new or existing supplier. b) Change in product appearance attributes	These changes would normally be expected to have an effect on the performance of the product.

3.2 Submission to Customer

The organization shall submit for PPAP approval prior to the ﬁrst production shipment in the following situations unless the authorized customer representative has waived this requirement NOTE: In the situations described below, prior notiﬁcation to, or communication with, the authorized customer representative is assumed.
The organization shall review and update, as necessary, all applicable items in the PPAP ﬁle to reﬂect the production process, regardless of whether or not the customer requests a formal submission. The PPAP ﬁle shall contain the name of the authorized customer representative granting the waiver and the date.

Requirement	Clariﬁcations
A new part or product (Le. a speciﬁc part,material, or color not previously supplied to the customer)	Submission is required for a new product (initial release) or a previously approved product that has a new or revised product/part number (e.g., sufﬁx) assigned to it. A new part/product or material added to a family may use appropriate PPAP documentation from a previously approved part within the same product family.
Correction of a discrepancy on a previously submitted part.	Submission is required to correct any discrepancies on a previously submitted part. A “discrepancy” can be related to: -The product performance against the customer requirements -Dimensional or capability issues -Supplier issues -Approval of a part replacing an interim approval -Testing, including material, performance, or engineering validation issues
Engineering change to design records,speciﬁcations, or materials for production product/part numbers(s).	Submission is required on any engineering change to the production product/part design record, speciﬁcations or materials.
Additionally, for Bulk Materials: Process technology new to the organization, not previously used for this product.

Section 4 — Submission To Customer – Levels of Evidence

4.1 Submission Levels
The organization shall submit the items and/or records speciﬁed in the level identiﬁed below

Level 1	Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to the customer.
Level 2	Warrant with product samples and limited supporting data submitted to the customer.
Level 3	Warrant with product samples and complete supporting data submitted to the customer.
Level 4	Warrant and other requirements as deﬁned by the customer.
Level 5	Warrant with product samples and complete support data reviewed at the organization’s manufacturing location.

The organization shall use level 3 as the default level for all submissions unless otherwise specified by the authorized customer representative. The minimum submission requirement for bulk materials is the PSW and the Bulk Materials Checklist. For Bulk Material PPAP submissions, check “Other” in the Reason for Submission Section on the PSW form and specify “Bulk Material.” This indicates that the ”Bulk Material Requirements Checklist” was used to packet. specify the PPAP requirements for the bulk material and shall be included in the submission

NOTE: The authorized customer representative may identify a submission level, different from the default level, that is to be used with each organization, or organization and customer part number combination. Different customer locations may assign different submission levels to the same organization manufacturing location. All of the forms referenced in this document may be replaced by computer-generated facsimiles. Acceptability of these facsimiles is to be conﬁrmed with the authorized customer representative prior to the ﬁrst submission.

Retention/Submission Requirements
Table lists submission and retention requirements. Mandatory and applicable requirements for a PPAP record are deﬁned in the PPAP manual and by the customer.

Section 5 – Part Submission Status

5.1 General

Upon approval of the submission, the organization shall assure that future production continues to meet all customer requirements
NOTE: For those organizations that have been classiﬁed as “self certifying” (PPAP submission level 1) by a speciﬁc customer, submission of the required organization-approved documentation will be considered as customer approval unless the organization is advised otherwise.

5.2 Customer PPAP Status

a) Approved
Approved indicates that the part or material, including all sub—components, meets all customer
requirements. The organization is therefore authorized to ship production quantities of the product, subject to releases from the customer scheduling activity.

b) Interim Approval
Interim Approval permits shipment of material for production requirements on a limited time or piece quantity basis. Interim Approval will only be granted when the organization has:

clearly deﬁned the non-compliances preventing approval; and,
prepared an action plan agreed upon by the customer. PPAP re—submission is required to obtain a status of “approved.”

Note: The organization is responsible for implementing containment actions to ensure that only
acceptable material is being shipped to the customer. Parts with a status of “Interim Approval” are not to be considered “Approved.” Material covered by an interim approval that fails to meet the agreed—upon action plan, either by the expiration date or the shipment of the authorized quantity, will be rejected. No additional shipments are authorized unless an extension of the interim approval is granted. For bulk materials, the organization shall use the “Bulk Material Interim Approval” form, or its equivalent.

5.2.3 Rejected

Rejected means that the PPAP submission does not meet customer requirements, based on the production lot from which it was taken and/or accompanying documentation. In such cases, the submission and/or process, as appropriate, shall be corrected to meet customer requirements. The submission shall be approved before production quantities may be shipped.

Section 6 — Record Retention

PPAP records , regardless of submission level, shall be maintained for the length of time that the part is active plus one calendar year. The organization shall ensure that the appropriate PPAP records from a superseded part PPAP ﬁle are included, or referenced in the new part PPAP ﬁle.
NOTE: An example of an appropriate document/record that should be carried forward from the old ﬁle to the new part ﬁle would be a material certiﬁcation from a raw material supplier for a new part that represents only a dimensional change from the old palt number. This should be identiﬁed by conducting a PPAP “gap analysis” between the old and new part numbers.

Part Submission Warrent

PART INFORMATION

1.Part Name and 2a. Customer Part Number: Engineering released ﬁnished end item part name and number.
2b. Org, Part Number: Part number deﬁned by the organization, if any.

3.Shown on Drawing Number: The design record that speciﬁes the customer part number being submitted.
4. Engineering Change Level & Date: Show the change level and date of the design record.

5.Additional Engineering Changes & Date: List all authorized engineering changes not yet incorporated in the design record but which are Incorporated in the part.

6.Safety and/or Government Regulation: “Yes” if so indicated by the design record, otherwise “No.”

7.Purchase Order Number: Enter this number as found on the contract/purchase order.

8.Weight: Enter the actual weight in kilograms to four decimal places unless otherwise speciﬁed by the customer.
9./10. Checking Aid Number, Change Level and Date: If requested by the customer, enter the checking aid number, its change level and date.

ORGANIZATION MANUFACTURING INFORMATION

11.Organization Name & Supplier/Vendor Code: Show the name and code assigned to the manufacturing site on the purchase order/contract.

12.Street Address, Region, Postal Code, Country: Show the complete address of the location where the product was manufactured.For “Region,” enter state, county, province, etc.

CUSTOMER SUBMITTAL INFORMATION

13 Customer Name/Division: Show the corporate name and division or operations group.

14 Buyer/Buyer Code: Enter the buyer’s name and code.

15 Application: Enter the model year, vehicle name, engine, transmission, etc.

MATERIALS REPORTING

16. Substances of Concern: Enter “Yes,” “No,” or “n/a”.
IMDS/Other Customer Format: Circle either “IMDS” or “Other Customer Format” as appropriate. If submitted via IMDS include: Module ID #, Version #, and Creation Date. If submitted via other customer format, enter the date customer conﬁrmation was received.

17. Polymeric Parts Identiﬁcation: Enter “Yes,” “No,” or “n/a”.

REASON FOR SUBMISSION

18. Check the appropriate box(es). For bulk materials, in addition to checking the appropriate box, check “Other” and write “Bulk Material” in the space provided.

SUBMISSION LEVEL

19. SUBMISSION LEVEL: Identify the submission level requested by the customer.

SUBMISSION RESULTS

20. Check the appropriate boxes for dimensional, material tests, performance tests, appearance evaluation, and statistical data.

21. Check the appropriate box. If “no,” enter the explanation in “comments” below.

22. Molds/Cavities/Production Processes: For instruction, see Part Submission Warrant

DECLARATION

23. Enter the number of pieces manufactured during the signiﬁcant production run.

24. Enter the time (in hours) taken for the signiﬁcant production run.

25. EXPLANATION/COMMENTS: Provide any explanatory comments on the Submission Results or any deviations from the Declaration. Attach additional information as appropriate.
26 CUSTOMER TOOL TAGGING/NUMBERING: Are customer-owned tools identified in accord with IATF 16949 and any customer-speciﬁc requirements, answer “Yes” or “No.” May not be applicable to OEM internal suppliers.
27 ORGANIZATION AUTHORIZED SIGNATURE: A responsible organization ofﬁcial, after verifying that the results show conformance to all customer requirements and that all required documentation is available, shall approve the declaration and provide Title, Phone Number, Fax Number, and Email address.
FOR CUSTOMER USE ONLY: Leave Blank

Appearance Approval Report

1.Customer part number: Engineering released customer part number.
2. Drawing Number: Use the number of the drawing on which the part is shown if different from
the part number.
3.Application: Enter the model year and vehicle or other program on which the part is used.
4.Part Name: Use the ﬁnished part name on the part drawing.
5.Buyer Code: Enter the code for speciﬁc buyer of part.
6/7. E/C Level & Date: Engineering change level and E/C date for this submission.
8. Organization Name: Organization responsible for submission (include supplier if applicable)
9. Manufacturing Location: Location Where part was manufactured or assembled.
10.Supplier/Vendor Code: Customer-assigned code for organization location where the part was
manufactured or assembled.
11.Reason for Submission: Check box(es) explaining the reason for this submission.
12.Organization Sourcing & Texture Information: List all first surface tools, graining source(s),
grain type(s), and grain and gloss masters used to check part
13. Pre-Texture Evaluation: To be completed by authorized customer representative
14. Color Sufﬁx: Use alphanumeric or numeric color identiﬁcation.
15. Tristimulus Data: List numerical (colorimeter) data of submission part as compared to the
customer-authorized master.
16. Master Number: Enter alphanumeric master identiﬁcation.
17. Master Date: Enter the date on which the master was approved.
18. Material Type: Identify first surface ﬁnish and substrate (e.g., paint/ABS).
19. Material Source: Identify ﬁrst surface and substrate suppliers. Example : Redspot /Dow.
20. Color Evaluation, Hue, Value, Chroma, Gloss and Metallic Brilliance: Visual assessment by
customer.
21. Color Shipping Sufﬁx: Color part number sufﬁx or color number.
22. Part Disposition: To be determined by customer (approved or rejected).
23. Comments: General comments by the organization or customer (optional).
24. Organization Signature, Phone No. & Date: Organization certiﬁcation that the document
information is accurate and meets all requirements speciﬁed.
25. Authorized Customer Representative Signature & Date: Authorized Customer
Representative approval signature.
THE AREAS INSIDE THE BOLD LINES ARE FOR CUSTOMER USE ONLY.

Production Part Approval, Dimensional Results

Production Part Approval, Material Test Results

Production Part Approval, performance Test Results

Bulk Material – Specific Requirements

Introduction

All organization supplying bulk materials shall comply with the requirements in this Appendix or use guidance herein for clariﬁcation of PPAP. The requirements in this Appendix are minimums and may be supplemented at the discretion of the organization and/or the customer.

Applicability

Organizations are responsible for applying PPAP to their suppliers of ingredients which have organization- designated special characteristics. Where OEM PPAP approval of a bulk material exists, evidence of that approval is sufﬁcient as the PPAP submission at other levels in the supply chain. Examples of bulk material include, but are not limited to: adhesives and sealants (solders, elastomers); chemicals (rinses, polishes, additives, treatments, colors/pigments, solvents); coatings (top coats, undercoats, primers, phosphates, surface treatments); engine coolants (antifreeze); fabrics; ﬁlm and ﬁlm laminates; ferrous and nonferrous metals (bulk steel, aluminum, coils, ingots); foundry (sand/silica, alloying materials, other minerals/ores); fuels and fuel Components; glass and glass components; lubricants (oils, greases, etc.); monomers, pre-polymers and polymers (rubbers, plastics, resins and their precursors); and performance ﬂuids (transmission, power steering, brake, refrigerant).

Bulk Materials Requirements Checklist
For bulk material, the PPAP elements required are deﬁned by the Bulk Materials Requirements Checklist. Any customer-speciﬁc requirements shall be documented on the Bulk Materials Requirements Checklist. Use the Bulk Materials Requirements Checklist as follows:

Required / Target Date: For each item listed in the checklist either enter a target date for completion of the element or enter “NR” for Not Required.
Primary Responsibility- Customer: Identify by name or function the individual who Will
review and approve the element.
Primary Responsibility – Organization: Identify by name or function the individual who will
assemble and assure the completeness of the element to be reviewed. 1
Comments / Conditions: Identify any qualifying information or references to attached documents that provide speciﬁc information regarding the element. For example, this may include speciﬁc formats to be used for the Design Matrix or acceptable tolerances for Measurement System Analysis (MSA) studies.
Approved by: Enter the initials of the authorized customer representative who has reviewed and accepted the element.
Plan agreed to by: Identify the individuals (and their functions) who made and agreed upon the project plan.

Design Matrix

Organizations supplying bulk material generally deal with the chemistry and functionality of the product being designed. Use of these suggestions will arrive at the same end point of a completed Design FMEA, but with greater applicability to bulk materials. For bulk materials, a Design Matrix, when required, shall be prepared prior to developing the Design FMEA. The Design Matrix determines the complex interactions of formula ingredients, ingredient characteristics, product characteristics, process constraints, and conditions for customer use. High impact items can then be effectively analyzed in the Design FMEA.

Design Matrix —— Elaboration
This matrix correlates customer expectations with the product design items. Construct the Design Matrix referring to the example which will follow:

Along the horizontal axis, list the Functions (Desired Attributes/Potential Failure Modes).
Along the vertical axis, list the design items as Potential Causes (Category/Characteristics) :
- Formula Ingredients
- Ingredient Characteristics
- Product Characteristics
- Process Constraints
- Conditions for Use (customer process constraints)
For each design item, enter the current robust threshold range levels and units.
Correlate the potential causes to the potential failure modes using a number, letter, or symbol representing the impact or strength of the relationship. Ask what would happen if a potential cause item is allowed to go under or over its robust minimum or maximum, respectively.
After completion of the rankings in the Design Matrix, review the category/characteristics for a preliminary assessment of Special Characteristics. Designate any Special Characteristics in column 1.
The high negative impact potential causes are transferred to the Design FMEA for analysis.

Negative impact on Customer expectation: High=3, Medium=2, Low =1,None=0, Unknown=?

Design FMEA

Effects of Failure and Severity Rankings

The following two steps provide an alternative method for identifying the Potential Effects of Failure and assigning a Severity Ranking.
List Effects of Failure

Consumer Effects- General terms identifying the loss experienced by the ultimate user of the product (e. g. the vehicle buyer).
Customer Effects- General terms identifying the loss experienced by the intermediate user of your product (e g., the vehicle manufacturer).

Assign a Severity Ranking to each Effect

See the Severity Deﬁnition and Evaluation Criteria in the Potential Failure Mode and Effects Analysis reference manual.
The goal for each of the items that multiply to arrive at the Risk Priority Number is to differentiate between the items in that category. The following ﬁgure provides a guideline for severity rankings. If your situation only uses a small portion of the scale then develop your own scale to improve the differentiation. If your situation is greater than two tiers back from the ﬁnal consumer, then the guideline figure should be adjusted to reﬂect the effects that will be felt by your customer’s customer.

Potential Cause(s)/Mechanisms of Failure and Design Matrix
From the Design Matrix (if used), list the high negative impact characteristics as the Potential Causes/Mechanisms of Failure which are associated with Potential Failure Modes. Mechanisms are generally described as over or under a certain threshold. These thresholds deﬁne the boundaries of the product approval and subsequent requirements for change notiﬁcation.

Likelihood of Occurrence Rankings
The following step provides an alternate method for assigning Occurrence ratings.
Rank Occurrence – the ranking scale in the Potential Failure Mode and Effects Analysis manual is
difﬁcult to relate to bulk materials and generally results in very low numbers with little differentiation in the ultimate risk. The following matrix is recommended as a replacement. It evaluates the frequency of occurrence based upon observed evidence the formulator has in the design.

Actual Experience: Obtained from appropriate experimentation on the-speciﬁc ﬁnal product and the potential failure mode.
Similar Experience: Based upon similar products or processes and the potential failure model.
Assumption: Based upon a clear understanding of the chemical impact of the material and the
potential failure mode.
Frequency ranking clariﬁcations:

High is deﬁned as – Repeated failures
Moderate is deﬁned as – Occasional failures
Low is deﬁned as – Relatively few failures

Current Design Controls

Design Control: Supplementing the Failure Mode Effects and Analysis manual bulk material design controls may also include:

Designed Experiments (DOE’ s)— List experiment #’ s
Customer validation tests and trial runs – e. g. gravelometer panels, fender sprayouts (list customer reference #’ S).
Test protocols- list Test Methods, Standard Operating Procedures etc.
Variation of supplier speciﬁcations.
Formulating practice robust ranges.

Design controls identiﬁed by a number should be available so that the relevant content of that control can be understood.

Likelihood of Detection Rankings

The next step provides an alternate method for assigning Detection rankings.
Rank Detection – the ranking scale in the Potential Failure Mode and Effects Analysis manual is difﬁcult to relate to bulk materials and generally results in very low numbers with little differentiation in the ultimate risk. The following matrix may be used. It evaluates the Detection as the ability of the current Design Control to actually detect a cause of failure and/or failure mode based upon the assessed Testing Method R&R’s percent of speciﬁcation range) and the quality of evidence.

DOE (Response Surface Analysis): Symmetric design space analyzed with appropriate statistical tools.
Screening Experiments: Screening design or ladder evaluation strategically set to develop DOE.
Assumption/Experience: Information/data based upon similar products or processes.
Note: The above R&R limits are suggested unless otherwise agreed upon by the customer and
organization. R&R calculations can initially be based using design matrix thresholds.

Process FMEA

Special Characteristics

If product characteristics/ attributes can have normal variation resulting in movement outside their design-intended robust range which results in signiﬁcant impact, they are designated special, and must be controlled by special controls.

Special Characteristics – Elaboration
For clarification purposes, the following figure is intended to demonstrate the ﬂow of potential special characteristics through the supply chain.

Control Plan

The Bulk Material Control Plan serves as a mechanism to:

Highlight Special Product/Process Characteristics and their controls
Link together sources of control methods, instructions and speciﬁcation/tolerance limits and reference them in one document

Additionally, this control plan is not intended to recreate speciﬁcationand/or tolerance limits that exist in other control sources such as batch tickets, work instructions and testing protocols.

Control Plan – Elaboration

Refer to the customer’s speciﬁed control plan format

Prototype (when required) — A listing of tests, evaluations and their associated specifications/tolerances used to assess an experimental or developmental formulation. This may be the only control plan that is product specific.
Pre-launch – Documentation of the product/process control characteristics, process controls affecting Special Characteristics, associated tests, and measurement systems employed during product scale up and prior to normal production.
Production – Documentation of the product/process control characteristics, process controls affecting Special Characteristics, associated tests, and measurement systems employed during normal production. Additional items may be included at the Organization’s discretion.

Pre-launch and production control plans may be applied to a family of products or speciﬁc processes.

Measurements system Analsis MSA Studies

Bulk materials often require further processing after sampling in order to make a measurement. Measurements are often destructive in nature and this prevents retesting the same sample. Measurement variability is often much larger for properties important in the process industries (e.g. viscosity and purity) than it is for properties measured in mechanical industries (e.g., dimensions). Measurement may account for 50% or more of the total observed variation. Standardized test methods (e. g. ASTM, AMS, ISO) are often followed. The organization need not re-verify bias, linearity, stability, and Gage R&R. MSA studies are not required where standardized tests are used, however it is still important for the organization to understand the measurement component of variation in the test methods used. Customer agreement on the actual requirements for MSA for either non-standard test methods or “new-to-supplier” test methods should be obtained during the planning phase. Any MSA studies should be applied to each test method associated with Special Characteristics, and not to each individual product measured by the test method. Therefore, the MSA studies should be conducted as broadly as possible across all products which use a particular test method. If the resulting variability is unacceptable, then either the studies should be conducted on a narrower class of products or action should be taken to improve the test method.

Initial Process Studies for special Characteristics

The manufacture of bulk materials consists of industries which span a variety of production processes, from high volume products to specialty products produced in small quantities no more than once or twice per year. Often the production process is completed or already in place before sufficient samples can be tested. By the time the product is made again, personnel and/or equipment may have changed. Also, these processes have numerous input variables, many control variables, and a variety of product variations. There are non-linearities – meaning for example that doubling the change in a particular input does not necessarily double the change in the output. The effects and relationships between all these variables and controls are also not usually known Without error. Multiple processes are usually interconnected, sometimes with feedback loops. There are also timing considerations and delays in reaction time. Further, measurements of component variables are generally less precise that measurements of component parts, such that in many cases correlated variables must be used

Master Sample

The requirements for master sample or equivalent shall be agreed by the customer and organization.
Physical Sample: Some bulk materials are stable and unchanging over an extended period of time (e.g., they do not signiﬁcantly change physical or chemical composition, if properly stored, for decades). In this case, a physical sample will serve as a Master Sample.
Analytical Sample Record: Other bulk materials change with time, but can be precisely quantiﬁed by appropriate analytical techniques. In this case the analytical record (e.g., Ultra—Violet or Infra—Red spectra “ﬁngerprint,” Atomic Absorption or Gas Chromatographic—Mass Spectrometric analysis) is an appropriate Master Sample.
Manufacturing Sample Record: When bulk materials can not be distinctly identiﬁed or change over time, a manufacturing sample record should be generated. The record Should include the information required to manufacture a “normal production size” run (lot or batch), according to the ﬁnal “Production Control Plan” supporting the PSW. This record provides an “audit trail” to the information which may be stored in various documents and or electronic systems. The following is the basic information suggested to accomplish this task:

The quantity of product produced.
The important performance results.
The raw materials utilized (including manufacturer, Lot #and important properties records).
The critical equipment required to manufacture the bulk material.
Analytical sample records, as described above, on the material as produced.
Batch ticket used to manufacture the bulk material.

Part Submission Warrant

A Part Submission Warrant shall be prepared and submitted for approval when required by the customer. If a customer agrees that PPAP is not required, no warrant needs to be prepared. The information required by the Submission Warrant which does not apply to bulk material (e. g., part weight, dimensional measurement) does not need to be provided. For those organizations that have been classiﬁed as “self certifying” by a speciﬁc customer, submission of a warrant signed only by the organization shall be evidence of PPAP approval, unless the organization is advised otherwise. For all other organizations, evidence of PPAP approval shall be a warrant signed by both the authorized customer representative and organization or other customer approval documents.

Interim Approval
Most products will achieve approval prior to initial use. In cases where approval cannot be obtained, a “Bulk Material Interim Approval” may be granted, A form is shown on the facing page; other forms may
be used.
COMPLETION OF THE BULK MATERIAL INTERIM APPROVAL FORM

1.ORGANIZATION NAME: Name assigned to Organization’s manufacturing location.
2. PRODUCT NAME: The Organization’s designated name for the product—as identiﬁed in the Customer’s Engineering Release Documents.
3. SUPPLIER/VENDOR CODE: Code (DUNS number or equivalent) assigned to the manufacturing location as shown on the Customer’s purchase order.
4. ENG. SPEC: Customer’s identified Specification through which the product is approved and released.
5. MANUF. SITE: Physical address of the manufacturing location as shown on the Customer’s purchase order.
6. PART #: Customer’s Part Number.
7.ENG. CHANGE #: Formula Revision Level or number identifying the formula.
8. FORMULA DATE: Engineering Release Date of the formula identiﬁed in item #7.
9. RECEIVED DATE: Customer Use Only.
10. RECEIVED BY: Customer Use Only (Customer Representative).
11.SUBMISSION LEVEL: Submission Level (1—5) that Organization is required to submit to as defined by the Customer.
12. EXPIRATION DATE: Date that the Interim Approval expires.
13. TRACKING CODE: Customer Use Only.
14. RE-SUBMISSION DATE: Date organization will resubmit for production approval.
15. STATUS: For each item, enter appropriate code (NR- Not Required, A-Approved, I-Interim).
16.SPECIFIC QUANTITY OF MATERIAL AUTHORIZED: Utilized when Interim Approval speciﬁes a specific quantity of volume of product.
17.PRODUCTION TRIAL AUTHORIZATION: Customer’s Engineering Release authorizing the use of the product in the Customer’s facility.
18.REASON(S) FOR INTERIM APPROVAL: Indicate reason for Interim Request.
19. ISSUES TO BE RESOLVED, EXPECTED COMPLETION DATE: For each item marked as “I” in #15, provide explanatory details regarding problem issues and furnish a date for problem resolution.
20.ACTIONS TO BE ACCOMPLISHED DURING INTERIM PERIOD, EFFECTIVE DATE: What is being done to ensure defective product is contained, date when the action was implemented and Exit Criteria necessary to end need for continuing the action or its individual. elements.
21. PROGRESS REVIEW DATE: Update on progress of problem resolution, generally the midpoint from issuance to expiration of the interim period.
22. DATE MATERIAL DUE TO PLANT: Date material is due to Customer’s site.
23. WHAT ACTIONS ARE TAKING PLACE TO ENSURE THAT FUTURE SUBMISSIONS WILL CONFORM TO ALL PPAP REQUIREMENTS BY THE SAMPLE PROMISE DATE? Why won’t this happen again?
24. ORGANIZATION: Responsible and Authorized Organization official to ensure compliance to the above mentioned actions and dates. ‘
25.PRODUCT ENG.: Product Engineer’s signature, printed name, phone number, and date.
26. MATERIALS ENG.: Material Engineer’s signature, printed name, phone number, and date.
27. QUALITY ENG: Quality Engineer’s signature, printed name, phone number, and date.
28. INTERIM APPROVAL NUMBER: Customer Use Only.

Customer Plant Connection .

1 Customer’s Responsibilities
The customer plant connection is a shared responsibility between the organization supplying bulk material and the customer. This connection deﬁnes the interaction of speciﬁc customer plant processing steps with Special Characteristics and ﬁnal product attributes of the bulk material. This interaction is especially signiﬁcant when bulk materials undergo chemical or physical transformation(s). Three key components of the Customer Plant Connection are the development of a Customer Process Matrix, determination of Special Characteristics from the Customer Process Matrix, and the preparation of a Control Plan which systematically directs corrective actions. For bulk materials, conducting the steps outlined in this “Customer Plant Connection” is highly recommended.
NOTE: It is not the intent of PPAP to compromise proprietary information.
2 Customer Plant Connection — Clariﬁcation
The following is applicable to materials that are transformed ﬁ‘om bulk (e.g., wet can of paint) to ﬁnal product (e. g., cured paint ﬁlm). This may not be applicable to all bulk materials (i.e. washer ﬂuid, engine oil, etc.). It is recognized by the organization that it is their responsibility to deliver the product to the customer with the characteristics of the bulk material per organization and customer agreement. The impact of the transformation of bulk materials by the customer plant on ﬁnal product attributes may be accounted for in the customer’s application process. During the transformation from bulk product to ﬁnal product, both bulk product characteristics and ﬁnal product attributes may be impacted by customer process controls. PPAP does not require a Process FMEA or Control Plan for the customer process. Since the product is frequently two products (bulk and ﬁnished), there is a shared responsibility for the ﬁnal product attribute. For example, percent solids and viscosity of a bulk coating which impacts the ﬁnal coating’s ﬁlm build attribute, may be affected by the customer’s mix room percent solvent reduction. The percent reduction process parameter may therefore be controlled to aid in control of ﬁlm build. The process steps at customer plants may be matrixed versus the Special Characteristics (determined jointly by the organization and the customer). Where high impact is evident, those process steps may be analyzed by the Process FMEA methodology. The Special Characteristics may then be determined, and be included in a Control Plan for the customer process. These special control characteristic items may be monitored and continuously improved.

3. Customer Plant Connection – Guidelines
The following is a recommended set of guidelines for the customer plant when implementing process controls for bulk materials.

Assemble cross—functional teams of customer personnel for each customer process area.
Include appropriate organization representatives on each team.
Select Champions for each team – these are the customer process owners (i.e., chief process
engineer, area supervisor, etc.).
Deﬁne critical customer handling, application steps and process parameters in each area.
Review the organization’s Design Matrix and Design FMEA items for application functions
which have been designated as Special Characteristics. Also review the desired ﬁnal product
attributes for items needing control.
From #4, develop a list of Special Characteristics and Attributes.
Construct a Customer Process Matrix, using #3 as the top, and #5 as the side. of a matrix.
Perform a Customer Process FMEA, focusing on the high‘impact customer process areas which impact the Special Characteristics.
Determine Special Characteristics from the Customer Process Matrix and PF MEA (e.g., paint ﬂuid ﬂow, gun distance, etc.).
Prepare a Control Plan for each affected customer process area. The plan might contain at a minimum all process steps containing Special Characteristics.
Monitor and record all Special Characteristics by appropriate means (control charts, checklists, etc.).
Ensure stability of Special Characteristics and continuously improve where possible.

Tires – Specific Requirements

1 Introduction and Applicability
An organization supplying tires shall comply with the requirements of PPAP. This Appendix is to be used as guidance for clariﬁcation of requirements unless otherwise speciﬁed by the authorized OEM customer representative. Performance testing, based upon design requirements used by each OEM to select tire construction (technical approval), reduces the need to repeat all tests during PPAP. Speciﬁc PPAP conﬁrmation tests are speciﬁed by each OEM.

2 Guidelines for PPAP Requirements
Signiﬁcant Production Run: Unless otherwise speciﬁed by the OEM, the size of the production run for the PPAP parts is a minimum of 30 tires.
NOTE: The above deﬁnition applies to all uses of “signiﬁcant production run” within PPAP. The typical development of a new tire design involves multiple builds of a small quantity of tires. Most designs are basic to the organization’s process. For the tire industry, PPAP is typically completed with an initial mold or molds, and well in advance of customer requirements for large volume production. The PPAP for the tire industry typically is derived from 1 to 8 hours of tire curing from the approved production process as speciﬁed in the organization’s control plan. PPAP is not required for additional molds that are brought on line in the approved production process.All additional molds shall be certiﬁed by the organization’s internal certiﬁcation criteria and documentation. For tires, tooling is deﬁned as the tire mold. This deﬁnition of tooling applies to all uses of “tooling” within PPAP.

Material Test Results: Testing is applicable only to ﬁnished tires and not to raw materials. Tire industry practice does not require chemical, physical, or metallurgical testing. Material test results are not required for PPAP.
Special Characteristics: Tire uniformity (force variation) and balance are designated Special Characteristics.
Appearance Approval Report (AAR): The AAR requirement is not applicable.
Master Sample: Master samples are not retained.
Process Flow Diagrams: See above

Checking Aids: Checking aids are not required.
PPAP Submission Warrant: Reporting of multiple cavities, molds, lines, etc. on the PSW is not required for tires.
Part Weight (Mass): PPAP tires are weighed to two (2) signiﬁcant decimals (XX.XX). The average is reported on the PSW to four (4) decimals (XX.XXXX)

3 Submission to Customer – Levels of Evidence
Retention/Submission Requirements : Records of items submitted (S) and retained (R) are maintained at appropriate locations designated by the organization.

Truck Industry – Specific Requirements

Introduction
An organization supplying to subscribing truck OEMs shall comply with the requirements in this Appendix or use guidance herein for clariﬁcation of PPAP. The requirements in this Appendix are minimums and may be supplemented at the discretion of the organization and/or the customer.

Applicability
The following additional requirements are added:

The Customer has the right to request a PPAP at any time to re-qualify a production component.
Feature Base Process or Part Number Generated components are PPAP qualiﬁed using the highest content conﬁguration to qualify the master part number. All other conﬁgurations may be approved with the submission of a PSW linking the new part number with the master part number.
For bulk material and standard catalog parts, the organization shall formally qualify their product to their design record and submit a PSW when requested by the customer.

Signiﬁcant Production Run

It is important that adequate quantities of parts be manufactured during this run to conﬁrm the quality and capability of production process at rate prior to full production. It is recognized that in low volume applications, sample sizes as small as 30 pieces may be utilized for preliminary process capability studies. When performing the Signiﬁcant Production Run, all aspects of variability within the production process should be considered and tested where practicable, e.g., set-up variability or other potential process related issues identiﬁed within the PFMEA. Sample sizes must be discussed and agreed to early in the APQP process. If projected volumes are so low
that 30 samples are not attainable prior to production, interim PPAP approval may be granted. A
dimensional report with 100% inspection on special characteristics is required during the interim period. Once the 30 consecutive production samples are produced, measured, and the quality index calculated and accepted, then the interim approval is changed to approved.

Dimensional Results
The organization shall submit, as part of the PPAP package, a copy of the drawing with each dimension, test, and or speciﬁcation identiﬁed with a unique number. These unique numbers shall be entered onto the dimensional or test results sheet as applicable, and actual results entered onto the appropriate sheets. The organization shall also identify the print zone for each numbered characteristic as applicable.

Material Test
The organization shall also submit a completed Design Veriﬁcation Plan and Report that summarizes appropriate performance and functional test results.

Quality Indices
When the customer speciﬁes special characteristics and the estimated annual usage is less than 500 pieces the organization shall document in their control plan that they will either perform 100% inspection and record the results or conduct an initial process capability study with a minimum of 30 production pieces and maintain SPC control charts of the characteristics during production.
For special characteristics that can be studied using variables data, the organization shall utilize One of the following techniques to study the stability of the process:
X-Bar and R Charts, n=5, plot minimum 6 subgroups or Individual X – Moving Range, plot minimum 30 data points.
When performing the initial process study, data shall be plotted from consecutive parts taken from the production trial run. These studies could be augmented or replaced by long-term results from the same or similar process run on the same equipment with prior customer concurrence.

Master Sample
The master sample shall be retained after PPAP approval when specified by the Customer.

Part Submission Warrant
When speciﬁed by the customer, organizations shall use the Truck Industry PSW

Part Weight (mass)
The organization may record the part weight of the part submitted on the PSW measured and expressed in kilograms to four significant ﬁgures (e.g., lOOOKg, 100.0Kg, 10.00Kg, and 1.000Kg) unless otherwise speciﬁed by the customer. To determine part weight, the organization shall individually weigh ten randomly selected parts, and calculate and report the average weight. At least one part shall be measured from each cavity, tool, line, or process used in product realization.

Customer Notiﬁcation
The organization shall notify the customer of any planned design and process changes. The customer may subsequently elect to require a submission for PPAP approval. Organizations supplying to subscribing truck OEMs are required to complete the Product Process Change notiﬁcation form to advise of forthcoming process or proprietary product changes.

Completion of the Part Submission Warrant
PART INFORMATION
1. Part Name: Engineering released finished end item part name.
2. Customer Part Number(s): Engineering released ﬁnished end item part number.
3. Part Revision Level: if applicable.
4. Tool Purchase Order Number: if applicable.
5. Engineering Drawing Change Level & Approval Date: Show change level and date for submission.

6. Additional Engineering Changes: Include all authorized engineering change documents and approval dates not yet incorporated on the drawing but which are incorporated in the part.

7. Shown on Drawing Number: The design record that speciﬁes the customer part number being submitted.

8. Purchase Order Number: Enter this number as found on the purchase order.
9. Part weight: Enter the actual weight in kilograms to four significant places.

10 Checking Aid Number: Enter the checking aid number, if one is used for dimensional inspection,
11. Its Engineering Change Level and Approval Date.

ORGANIZATION MANUFACTURING INFORMATION

12. Organization Name and Code: Show the code assigned to the manufacturing location on the purchase order.

13. Organization Manufacturing Address: Show the complete address of the location where the product was manufactured.

SUBMISSION INFORMATION

14. Customer Name/Division: Show the corporate name and division or operations group.

15. Contact Name: Enter the name of your customer contact.

16. Application: Enter the model year, vehicle name, or engine, transmission, etc.

17. Check the appropriate box to indicate Substances of Concern/ISO marking reporting.

REASON FOR SUBMISSION

18. Check the appropriate box. Add explanatory details in the “other” section.

REQUESTED SUBMISSION LEVEL

19. Identify the submission level requested by your customer. Check the submission items if a level 4 is requested.

DECLARATION

20. Explanation/Comments: Provide any explanatory details on the submission results; additional information may be attached as appropriate.

21. Enter the number or code that identiﬁes the speciﬁc mold, cavity, and/or production process used to manufacture the sample parts.

22.The responsible supplier official, after verifying that the results show conformance to all customer requirements and that all required documentation is available, shall approve the declaration and provide Title, Phone Number, Email Address, and Fax Number.

FOR CUSTOMER USE ONLY: Leave blank.

IATF 16949:2016 clause 9.3.1.1 Management review, Clause 9.3.2.1 Management review inputs and Clause 9.3.3.1 Management review outputs

The purpose of conducting management reviews of the QMS is to gauge the health of the QMS. The review must determine QMS suitability, adequacy and effectiveness. Are the QMS resources and controls that were planned and implemented, suitable and adequate for the QMS to be effective in achieving customer and regulatory requirements; and in achieving quality objectives? Are changes needed to improve product, processes and use of resources? The process must address the frequency, schedule, quorum and agenda for review meetings to be attended by top management. For the management review process itself to be effective, top management must plan the review of all agenda items with some regularity to gauge the health of the QMS and take timely action to change or improve any part of it, including the quality policy and objectives. To avoid problems on frequency and scope of review, an effective way would be incorporate QMS agenda items into regular monthly or quarterly operational meetings. Some OEM’s require management review to be held not less than once a year The review of QMS deployment and performance might be measured through gap analysis for new systems and the results of internal audits for established systems. Management review must include the results of such analysis and audits. The costs of internal and external poor quality as well as process metrics for all processes must be measured and evaluated against business objectives and customer satisfaction goals. Management review input should preferably be in summary form, showing QMS and operational performance measured against the business and quality plans, customer and regulatory objectives and goals. Appropriate actions must result from such reviews. Review decisions and actions must relate to improving products and processes or even creating new ones; providing more resources or perhaps improving the efficiency of existing resources; improving QMS controls; policies and objectives; and improving overall QMS effectiveness and customer satisfaction. Responsibilities and timelines should accompany these decisions and actions. The performance of these actions must be followed up at subsequent management review meetings. Performance indicators to measure the effectiveness of the management review process could include – achievement of quality objectives and improvement in customer satisfaction rating. You must identify and document the management review process as part of your QMS . You must also identify what specific documents are needed for effective planning, operation and control of this process . These documents may include – a documented procedure; review schedule; agenda and action forms; etc., combined with unwritten practices, procedures and methods. Management review records must include topics discussed; decisions; responsibilities for corrective or improvement actions and related timelines; provision of resources; and follow-up actions from previous management reviews.

clause 9.3.1.1 Management review

In addition the the requirements given ISO 9001:2015 Clause 9.3.1 Management review , clause 9.3.1.1 requires that Management review must be conducted at least annually. The frequency of management review(s) must be increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system and performance-related issues.

please click here for ISO 9001:2015 Clause 9.3.1 Management review

Conducting management reviews at least annually is a fundamental requirement of a Quality Management System (QMS) . However, it’s crucial to recognize that the frequency of management reviews should be flexible and responsive to changes and risks that could impact the QMS and its ability to meet customer requirements. Here’s why this approach is important:

Adaptive to Change: The business environment is dynamic, and internal or external changes can have a significant impact on the QMS. Increasing the frequency of management reviews when changes occur allows the organization to quickly assess and respond to new challenges or opportunities.
Risk Management: Changes in the internal or external environment can introduce new risks or modify existing ones. By conducting more frequent management reviews in response to heightened risk, the organization can proactively address potential compliance and performance-related issues.
Customer Focus: The primary goal of a QMS is to meet customer requirements and enhance customer satisfaction. Adapting the frequency of management reviews based on risks to compliance ensures that customer needs and expectations are consistently met.
Continuous Improvement: Frequent management reviews enable the organization to continuously monitor its processes, identify areas for improvement, and implement corrective actions promptly.
Operational Agility: Increasing the frequency of management reviews in response to performance-related issues ensures that the organization remains agile and can swiftly address any operational shortcomings.
Regulatory Compliance: Regulatory requirements and standards may evolve over time. More frequent management reviews can help ensure ongoing compliance with these changing requirements.
Data-Driven Decision-Making: Frequent management reviews provide a steady flow of up-to-date information that top management can use to make informed decisions and guide the organization’s strategic direction.
Organizational Learning: Conducting management reviews more frequently facilitates organizational learning and enhances the organization’s ability to adapt and innovate.
Stakeholder Engagement: By reviewing and addressing changes and risks on a more regular basis, the organization can better engage stakeholders and demonstrate its commitment to quality and continuous improvement.
Performance Monitoring: Frequent management reviews allow for real-time monitoring of performance-related metrics and indicators, helping the organization maintain a high level of operational excellence.
Efficient Problem Solving: More frequent reviews enable quicker identification and resolution of problems, minimizing disruptions and potential negative impacts.
Cultural Emphasis on Quality: A culture of quality and continuous improvement is reinforced when management places a strong emphasis on regularly evaluating and enhancing the QMS.

The periodicity of management reviews should be matched to the evidence that demonstrates the effectiveness of the system. Initially the reviews should be frequent, say monthly, until it is established that the system is effective. Thereafter the frequency of reviews can be modified. If performance has already reached a satisfactory level and no deterioration appears within the next three months, extend the period between reviews to six months. If no deterioration appears in six months extend the period to twelve months. It is unwise to go beyond twelve months without a review as something is bound to change that will affect the system. Shortly after a reorganization (the launch of a new product/service, breaking into a new market, securing new customers, etc.), a review should be held to establish if performance has changed. After new technology is planned, a review should be held before and afterwards to measure the effects of the change. Your procedures need to state the criteria for scheduling the reviews. Don’t set them at a specific period, other than a maximum interval, as it limits your ﬂexibility. You can define the interval between reviews in the minutes of the review meeting, thereby giving you the ﬂexibility to change the frequency when desirable.

Clause 9.3.2.1 Management review inputs

In addition the the requirements given ISO 9001:2015 Clause 9.3.2 Management review input , clause 9.3.2.1 requires that Input to management review to include cost of poor quality (cost of internal and external non conformance); measures of process effectiveness; measures of process efficiency; product conformance; assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product; customer satisfaction ; review of performance against maintenance objectives ;warranty performance if applicable;review of customer scorecards if applicable; identification of potential field failures identified through risk analysis (such as FMEA) ; actual field failures and their impact on safety or the environment.

please click here for ISO 9001:2015 Clause 9.3.2 Management review inputs

Cost of poor quality

A management review is an essential part of a quality management system, where the organization’s top management evaluates the performance of the system and makes decisions for improvement. Including the cost of poor quality in this review can provide valuable insights into the effectiveness of your quality processes. Here’s what you might want to include:

Cost of Internal Nonconformance: This refers to the expenses incurred due to quality issues within your organization. It includes the cost of rework, scrap, retesting, and any other resources required to rectify nonconforming products or processes before they leave your premises. It’s important to calculate these costs accurately to understand the impact on your operations.
Cost of External Nonconformance: External nonconformance refers to quality issues that are identified after your products or services have reached customers or the market. This includes costs associated with customer complaints, returns, replacements, warranty claims, legal issues, and damage to your brand reputation. Calculating these costs helps you gauge the effects of poor quality on customer satisfaction and your organization’s financial health.
Data Analysis and Reporting: Provide detailed data and analysis regarding the instances of internal and external nonconformance. Present trends, patterns, and the frequency of occurrences. Visual aids such as graphs and charts can make the data more accessible and understandable for management.
Root Cause Analysis: Include information about the root causes of the nonconformances. Highlight any recurring issues or common factors contributing to poor quality. This will help management identify areas for improvement and allocate resources effectively.
Corrective and Preventive Actions: Outline the corrective and preventive actions that have been taken to address the identified nonconformances. Describe the effectiveness of these actions and whether they have successfully prevented similar issues from recurring.
Impact on Overall Performance: Discuss how the cost of poor quality has impacted the organization’s financial performance, customer satisfaction, and overall business objectives. This could include missed opportunities, increased operational costs, and potential lost revenue.
Continuous Improvement Initiatives: Propose strategies for continuous improvement to reduce the cost of poor quality. These could include process optimization, employee training, quality control enhancements, and other measures to prevent nonconformance from occurring in the future.
Future Goals and Targets: Set specific goals and targets related to reducing the cost of poor quality. Outline a plan for how these goals will be achieved and the expected impact on the organization’s bottom line and reputation.
Management Decision and Action: Based on the information presented, management should make informed decisions regarding resource allocation, process changes, and quality improvement initiatives. These decisions should be documented and tracked for accountability.

Remember, the goal of including the cost of poor quality in a management review is to provide a clear picture of how quality issues are affecting the organization and to drive continuous improvement efforts.

Measures of process effectiveness;

Including measures of process effectiveness in the management review of a Quality Management System (QMS) is crucial for evaluating the overall performance of the system and making informed decisions for improvement. These measures help management understand how well the organization’s processes are functioning, whether they are achieving their intended objectives, and where adjustments or enhancements might be needed. Here are some key points to consider:

Key Performance Indicators (KPIs): Identify and present relevant KPIs that provide insights into process effectiveness. These could include metrics such as on-time delivery, customer satisfaction scores, defect rates, rework rates, cycle times, and other indicators that directly reflect the performance of your processes.
Process Efficiency: Evaluate the efficiency of your processes by analyzing factors like resource utilization, waste reduction, and process cycle times. If you’ve implemented process improvements, provide data that demonstrates their impact on efficiency.
Process Stability and Control: Assess the stability and control of your processes by utilizing statistical process control (SPC) charts, control limits, and other tools. Highlight instances where processes have remained within acceptable control limits and flag any trends that could indicate instability.
Root Cause Analysis: Share information about root cause analysis conducted for any process deviations or failures. This could include detailing the methods used to identify the underlying causes, the corrective actions taken, and the outcomes of those actions.
Customer Feedback: Incorporate feedback from customers related to your processes. Discuss any trends in customer complaints, suggestions, or comments that can provide insights into process effectiveness and areas for improvement.
Process Audits and Inspections: Provide results from internal and external audits or inspections of your processes. Highlight any findings, corrective actions taken, and improvements made based on audit recommendations.
Employee Input: Gather input from employees who are directly involved in the processes. Their perspectives can offer valuable insights into process effectiveness and areas where adjustments could lead to improvements.
Comparison to Objectives: Compare the actual performance of processes to the objectives set in your QMS. This helps management assess whether processes are meeting their intended goals and if any adjustments are necessary.
Trends and Patterns: Present trends and patterns in process performance over time. Visual representations like trend charts or graphs can help management easily identify improvements, declines, or areas of inconsistency.
Benchmarks and Best Practices: Compare your process effectiveness to industry benchmarks or best practices. This can provide context and help management understand where your organization stands in relation to others in the same field.
Impact on Business Goals: Discuss how process effectiveness contributes to achieving overall business objectives, such as increased revenue, reduced costs, improved customer satisfaction, and enhanced competitiveness.
Continuous Improvement: Propose actionable suggestions for continuous improvement based on the analysis of process effectiveness. Highlight areas where focused efforts could lead to meaningful enhancements.

By including measures of process effectiveness in your management review, you enable top management to make informed decisions about allocating resources, prioritizing improvements, and ensuring the QMS aligns with the organization’s strategic goals.

Measures of process efficiency

Including measures of process efficiency in the management review of a Quality Management System (QMS) is essential for evaluating the effectiveness of your organization’s processes and identifying opportunities for improvement. Process efficiency is a critical aspect of a well-functioning QMS, as it directly impacts productivity, resource utilization, and overall operational performance. Here’s why it’s important to include measures of process efficiency in your management review:

Performance Evaluation: Process efficiency metrics provide a clear and quantifiable way to assess how well your processes are performing. These metrics help management understand whether processes are meeting their intended objectives and where improvements can be made.
Resource Utilization: Efficiency measures allow you to gauge how effectively your resources (time, labor, materials, equipment) are being used in your processes. Management can identify areas of resource waste or inefficiency and take corrective actions.
Waste Reduction: Measuring process efficiency helps you identify sources of waste, such as rework, excessive wait times, or redundant activities. By pinpointing these areas, you can implement strategies to reduce waste and optimize resource allocation.
Cost Savings: Efficient processes lead to reduced operational costs. Including efficiency metrics in the management review allows management to quantify the financial impact of process improvements and prioritize initiatives that contribute to cost savings.
Process Variability: Monitoring process efficiency helps identify variations in performance. Consistent and efficient processes result in lower variability, leading to more predictable outcomes and higher quality products or services.
Continuous Improvement: Efficiency measures provide a basis for continuous improvement efforts. By tracking efficiency over time, you can assess the impact of improvement initiatives and identify trends that require further attention.
Goal Alignment: Process efficiency metrics can be aligned with your organization’s strategic goals. Management can evaluate whether process efficiency is contributing to achieving broader objectives and adjust strategies accordingly.
Operational Performance: Efficient processes lead to smoother operations, reduced bottlenecks, and faster cycle times. This can result in improved customer satisfaction, shorter lead times, and better overall performance.
Decision-Making: Including efficiency metrics in the management review equips decision-makers with data-driven insights. This enables informed decisions regarding process optimization, resource allocation, and investments in technology or training.
Employee Engagement: Efficient processes often lead to improved employee morale and engagement. When employees see the positive outcomes of their efforts, it can boost motivation and satisfaction.
Benchmarking and Best Practices: Process efficiency metrics can be compared to industry benchmarks or best practices. This external perspective provides valuable context and helps identify areas for improvement.
Communication and Transparency: Inclusion of process efficiency measures in the management review promotes transparency and open communication within the organization. It fosters a culture of accountability and continuous improvement.

When presenting measures of process efficiency in the management review, consider using visual aids such as graphs, charts, and trend analyses to make the data more accessible and understandable for management. Be prepared to discuss the implications of the efficiency metrics, any improvement initiatives undertaken, and future plans for optimizing processes.

Product conformance

Including product conformance in the management review of a Quality Management System (QMS) is a critical aspect of evaluating the overall effectiveness of your organization’s quality processes. Product conformance refers to the extent to which products meet specified requirements and standards. Here’s why it’s important to include product conformance in your management review:

Customer Satisfaction: Product conformance directly impacts customer satisfaction. By reviewing product conformance data, management can assess how well your products are meeting customer expectations and identify areas for improvement to enhance customer satisfaction.
Quality Performance: Product conformance is a fundamental indicator of the quality of your products. It provides insights into the consistency and reliability of your manufacturing or service delivery processes.
Compliance: In many industries, products must adhere to specific regulatory and industry standards. Management needs to ensure that products are conforming to these requirements to avoid legal and compliance issues.
Risk Management: Non-conforming products can pose risks to both customers and the organization. By monitoring product conformance, management can identify potential risks and take proactive measures to mitigate them.
Process Evaluation: Product conformance data can reveal patterns and trends in manufacturing or service delivery processes. This information helps management identify areas of improvement and make informed decisions about process adjustments.
Root Cause Analysis: If non-conforming products are identified, including details about root cause analysis in the management review helps management understand the underlying issues and take appropriate corrective actions.
Continuous Improvement: Product conformance metrics provide a baseline for evaluating the impact of continuous improvement efforts. By tracking changes in conformance rates over time, management can assess the effectiveness of improvement initiatives.
Supplier Performance: If your organization relies on suppliers, product conformance data can also reflect their performance. This can help management make informed decisions about supplier relationships and collaborations.
Decision-Making: Product conformance data informs decision-making related to process optimization, resource allocation, training needs, and investment in quality improvement initiatives.
Communication and Accountability: Including product conformance in the management review promotes transparency and accountability within the organization. It ensures that top management is aware of the current state of product quality and can take appropriate actions to drive improvements.
Strategic Alignment: Product conformance data can be aligned with your organization’s strategic goals. If product quality is a key differentiator or a core part of your value proposition, monitoring conformance helps ensure alignment with strategic objectives.
Benchmarking: Comparing your product conformance rates to industry benchmarks or best practices provides valuable insights into your competitive position and areas where you can excel.

When presenting product conformance data in the management review, consider providing clear and concise summaries, visual aids such as charts and graphs, and contextual information about the significance of the data. Highlight any improvement initiatives, corrective actions taken, and plans for maintaining or enhancing product conformance in the future.

Assessments of manufacturing feasibility

Including assessments of manufacturing feasibility for changes to existing operations, new facilities, or new products in the management review of a Quality Management System (QMS) is crucial for ensuring that potential risks and challenges are evaluated before implementation. This proactive approach helps maintain product quality, operational efficiency, and customer satisfaction. Here’s why it’s important to include these assessments in your management review:

Risk Identification and Mitigation: Assessing manufacturing feasibility helps identify potential risks and challenges that may arise during changes to existing operations, new facility setups, or the introduction of new products. This enables management to take preventive measures and develop strategies to mitigate these risks.
Resource Allocation: Evaluating manufacturing feasibility provides insights into the resources (including manpower, equipment, materials, and time) required for successful implementation. Management can allocate resources effectively and make informed decisions regarding investment and capacity planning.
Operational Efficiency: Feasibility assessments allow management to identify bottlenecks, process constraints, and potential inefficiencies that could impact production or service delivery. Addressing these issues before implementation can lead to smoother operations and reduced disruptions.
Quality Assurance: Changes to operations or the introduction of new products can impact product quality. Assessing manufacturing feasibility helps ensure that quality standards can be maintained or enhanced throughout the changes.
Cost Management: Feasibility assessments enable management to estimate the costs associated with changes to operations, new facilities, or new products. This allows for accurate budgeting and cost control.
Timeline and Project Planning: Understanding manufacturing feasibility helps in developing realistic timelines for implementation. Management can set achievable milestones and deadlines, reducing the likelihood of delays.
Alignment with Strategy: Assessing manufacturing feasibility ensures that proposed changes align with the organization’s overall strategic goals and objectives. Management can evaluate whether the changes support the organization’s mission and long-term vision.
Cross-Functional Collaboration: Feasibility assessments often involve input from various departments, promoting cross-functional collaboration and communication. This holistic approach ensures that all relevant perspectives are considered.
Regulatory Compliance: For industries with regulatory requirements, assessing manufacturing feasibility helps identify potential compliance challenges early on. Management can ensure that changes and new initiatives meet all necessary regulations and standards.
Decision-Making: Including feasibility assessments in the management review provides decision-makers with data-driven insights. This allows management to make well-informed decisions about the feasibility of proposed changes and the potential impact on the organization.
Learning from Past Experiences: If the organization has undergone similar changes in the past, assessing manufacturing feasibility provides an opportunity to learn from previous experiences and apply lessons learned.
Continuous Improvement: The feasibility assessment process itself can be subject to continuous improvement. Management can analyze the effectiveness of past assessments, identify areas for enhancement, and refine the assessment process over time.

When presenting assessments of manufacturing feasibility in the management review, it’s important to provide clear and comprehensive documentation of the assessment process, findings, and recommendations. Visual aids such as flowcharts, diagrams, and cost breakdowns can help convey complex information effectively. Additionally, highlighting any lessons learned or best practices from previous feasibility assessments can add value to the management review process.

Customer satisfaction

Including customer satisfaction in the management review of a Quality Management System (QMS) is essential for maintaining a customer-centric approach and ensuring that your organization’s products or services meet or exceed customer expectations. Customer satisfaction is a key indicator of the effectiveness of your quality processes and the overall success of your business. Here’s why it’s important to include customer satisfaction in your management review:

Customer-Centric Focus: Customer satisfaction emphasizes the importance of meeting customer needs and preferences. Including customer satisfaction in the management review reinforces a customer-centric mindset throughout the organization.
Performance Evaluation: Customer satisfaction provides direct feedback on how well your products, services, and processes are performing from the customer’s perspective. Management can evaluate the success of your QMS in delivering value to customers.
Quality Assurance: Satisfied customers often indicate that your products or services are meeting quality standards and conforming to their expectations. Management can use customer satisfaction data as an assurance of product and service quality.
Continuous Improvement: Customer feedback highlights areas for improvement. By analyzing customer satisfaction data, management can identify trends, recurring issues, or opportunities for enhancement that should be addressed through continuous improvement efforts.
Competitive Advantage: High customer satisfaction can differentiate your organization from competitors. Including customer satisfaction data in the management review allows management to assess how well your organization is positioned in the market.
Reputation Management: Satisfied customers are more likely to promote your brand and refer others. Monitoring customer satisfaction helps protect and enhance your organization’s reputation.
Risk Identification: Low customer satisfaction scores or negative feedback can signal potential risks to the organization’s success. Management can identify these risks and take appropriate actions to mitigate them.
Communication: Including customer satisfaction data in the management review fosters open communication between different levels of the organization. It encourages a shared understanding of customer needs and expectations.
Goal Alignment: Customer satisfaction metrics can be aligned with your organization’s strategic goals. Management can assess whether customer satisfaction efforts are contributing to broader business objectives.
Employee Engagement: Positive customer feedback can boost employee morale and engagement by showcasing the impact of their efforts on customer experiences.
Product and Service Development: Customer feedback can provide insights for developing new products or enhancing existing ones based on customer preferences and needs.
Relationship Building: Monitoring customer satisfaction fosters stronger relationships with customers. Satisfied customers are more likely to become loyal, long-term clients.

When presenting customer satisfaction data in the management review, consider providing a comprehensive analysis that includes overall satisfaction scores, specific feedback from customers, trends over time, and any actions taken based on customer feedback. Visual aids such as charts, graphs, and customer testimonials can help convey the information effectively. Discuss how customer satisfaction aligns with the organization’s goals and how it informs decisions regarding process improvements and strategic directions.

Review of performance against maintenance objectives

Including a review of performance against maintenance objectives in the management review of a Quality Management System (QMS) is crucial for ensuring the effective management of your organization’s assets and facilities. Maintenance objectives play a significant role in maintaining operational efficiency, preventing downtime, and ensuring the reliability of your processes and products. Here’s why it’s important to include this review in your management review:

Asset Reliability: Reviewing performance against maintenance objectives allows management to assess the reliability and availability of critical assets. This ensures that equipment and facilities are properly maintained and capable of delivering consistent performance.
Operational Continuity: Effective maintenance helps prevent unexpected breakdowns and downtime, ensuring that your organization can operate smoothly and meet production or service delivery commitments.
Resource Allocation: Performance against maintenance objectives provides insights into resource utilization, including labor, materials, and time. Management can make informed decisions about resource allocation and budget planning.
Cost Management: Reviewing maintenance performance allows management to evaluate the cost-effectiveness of maintenance activities. It helps identify opportunities to optimize costs while ensuring asset reliability.
Compliance and Regulatory Requirements: Maintenance objectives often include compliance with regulatory standards and safety requirements. A review ensures that your organization is meeting these obligations and avoiding potential legal or operational risks.
Performance Metrics: Assessing maintenance objectives provides a basis for measuring key performance indicators (KPIs) related to asset reliability, maintenance efficiency, mean time between failures (MTBF), mean time to repair (MTTR), and other relevant metrics.
Root Cause Analysis: If maintenance objectives are not being met, conducting a root cause analysis can help identify underlying issues or process gaps that need to be addressed.
Process Improvement: By analyzing performance against maintenance objectives, management can identify opportunities for process improvement, such as optimizing maintenance schedules, implementing predictive maintenance strategies, or enhancing maintenance training programs.
Impact on Quality and Customer Satisfaction: Effective maintenance contributes to consistent product or service quality. A review ensures that maintenance practices are aligned with quality objectives, leading to improved customer satisfaction.
Risk Management: Maintenance objectives help manage risks associated with equipment failures, which can lead to safety hazards, production delays, and customer dissatisfaction.
Sustainability and Environmental Impact: Maintenance practices can impact energy consumption, waste generation, and environmental sustainability. Reviewing maintenance objectives allows management to assess the organization’s commitment to environmental responsibility.
Continuous Improvement: Including a review of maintenance performance supports the principle of continuous improvement within the QMS. It encourages a proactive approach to identifying areas for enhancement and implementing corrective actions.

When presenting the review of performance against maintenance objectives in the management review, provide data on maintenance KPIs, relevant metrics, and trends over time. Highlight any notable achievements, challenges, or improvement initiatives related to maintenance practices. Discuss how maintenance objectives align with the organization’s broader goals and contribute to operational excellence. Visual aids, such as charts, graphs, and before-and-after comparisons, can help convey the information effectively.

Warranty performance

Including a review of warranty performance in the management review of a Quality Management System (QMS) is essential for evaluating the quality and reliability of your products or services from the customer’s perspective. Warranty performance provides valuable insights into how well your organization’s offerings meet customer expectations, and it plays a significant role in maintaining customer satisfaction and trust. Here’s why it’s important to include warranty performance in your management review:

Customer Satisfaction: Warranty performance directly impacts customer satisfaction. A review of warranty data helps management understand whether products are meeting customer expectations, and whether any issues are being addressed promptly and effectively.
Product Quality: Monitoring warranty performance allows management to assess the overall quality and reliability of products. Patterns in warranty claims can indicate potential design flaws, manufacturing defects, or other issues that need to be addressed.
Defect Identification: Warranty performance data can highlight recurring defects or trends in product failures. This information is crucial for root cause analysis and for making improvements to prevent similar issues in the future.
Continuous Improvement: Reviewing warranty performance contributes to a culture of continuous improvement. By analyzing warranty data, management can identify areas for enhancement in design, manufacturing, and quality control processes.
Risk Management: Effective warranty management helps mitigate financial and reputation risks. By addressing warranty issues promptly, management can prevent escalation of problems and protect the organization’s brand image.
Resource Allocation: Warranty performance review informs decisions about resource allocation for addressing warranty claims, customer support, repairs, replacements, and other related activities.
Supplier Evaluation: Warranty data can provide insights into the performance of suppliers and components. Management can assess the impact of external factors on product quality.
Root Cause Analysis: When warranty issues arise, a review can include details about root cause analysis and corrective actions taken. This demonstrates the organization’s commitment to addressing problems systematically.
Decision-Making: Warranty performance data informs decisions regarding product design changes, process improvements, and customer support strategies.
Product Development: Insights from warranty data can guide product development efforts by identifying areas for innovation and enhancements based on real-world usage and feedback.
Communication: Including warranty performance in the management review promotes transparency and open communication within the organization. It ensures that management is aware of customer experiences and any challenges related to product quality.
Legal and Regulatory Compliance: Warranty-related issues can have legal and regulatory implications. A review of warranty performance ensures that the organization is meeting its obligations in this regard.

When presenting warranty performance in the management review, include data on warranty claims, analysis of claim types, trends, and the effectiveness of corrective actions. Visual aids, such as warranty claim trend charts, comparison graphs, and summaries of significant warranty-related actions, can help convey the information effectively. Discuss how warranty performance aligns with the organization’s quality goals and how it informs decision-making and process improvements.

Customer scorecards

Including a review of customer scorecards in the management review of a Quality Management System (QMS) is a valuable practice for assessing your organization’s performance from the customer’s perspective. Customer scorecards provide a comprehensive and quantifiable way to evaluate how well your products, services, and processes are meeting customer expectations and requirements. Here’s why it’s important to include this review in your management review:

Customer-Centric Focus: Customer scorecards emphasize the importance of meeting customer needs and preferences. Including these scorecards in the management review reinforces a customer-centric approach and helps align the organization’s efforts with customer expectations.
Performance Measurement: Customer scorecards offer specific metrics and KPIs that reflect the customer’s perception of your organization’s performance. A review provides insights into how well your products and services are being received.
Continuous Improvement: By analyzing customer scorecards, management can identify areas for improvement and implement strategies to enhance customer satisfaction and loyalty.
Objective Feedback: Customer scorecards provide objective feedback that can guide decision-making. Management can base their actions on quantifiable data rather than assumptions.
Risk Mitigation: Reviewing customer scorecards helps identify potential risks related to customer dissatisfaction, allowing management to take proactive measures to address concerns.
Product and Service Development: Insights from customer scorecards can inform product and service development efforts. Management can identify areas where innovation is needed or where existing offerings can be enhanced.
Competitive Analysis: Customer scorecards can include comparisons to competitors’ performance. This provides valuable insights into your organization’s competitive position and areas where you can excel.
Relationship Building: By reviewing customer scorecards, management can understand the strength of customer relationships and identify opportunities to strengthen ties with key clients.
Alignment with Quality Goals: Customer scorecards reflect the effectiveness of your QMS in delivering quality products and services. Management can assess whether the QMS is achieving its intended outcomes.
Communication: Including customer scorecards in the management review fosters open communication and collaboration between different departments and levels of the organization.
Benchmarking: Customer scorecards can be benchmarked against industry standards or best practices, providing context for your organization’s performance.
Employee Engagement: Sharing positive feedback from customer scorecards can boost employee morale and engagement by showcasing the impact of their work on customer satisfaction.

When presenting customer scorecards in the management review, provide a summary of key metrics, trends over time, and any actions taken based on customer feedback. Use visual aids such as charts, graphs, and comparative analyses to convey the information effectively. Discuss how the feedback from customer scorecards aligns with the organization’s quality objectives and how it influences decisions regarding process improvements and strategic direction

Field failures

Including the identification of potential field failures through risk analysis (such as Failure Modes and Effects Analysis or FMEA), as well as reporting actual field failures and their impact on safety or the environment, in the management review of a Quality Management System (QMS) is crucial for ensuring product safety, regulatory compliance, and environmental responsibility. Here’s why it’s important to include these aspects in your management review:

Risk Management: Identifying potential field failures through risk analysis (FMEA) helps the organization proactively address and mitigate risks before they escalate into actual field failures. This proactive approach prevents safety hazards, quality issues, and environmental impacts.
Prevention of Harm: By addressing potential field failures early, management can take preventive measures to avoid harm to customers, end-users, employees, and the environment.
Product Quality and Safety: Field failures directly impact product quality and safety. Including these failures in the management review emphasizes the importance of maintaining high-quality standards and ensuring that products meet safety requirements.
Regulatory Compliance: Actual field failures and their impact on safety or the environment are often subject to regulatory oversight. Including these failures in the management review demonstrates the organization’s commitment to meeting regulatory requirements.
Customer Satisfaction: Field failures can lead to customer dissatisfaction and damage the organization’s reputation. Reviewing actual failures and their impacts reinforces the importance of meeting customer expectations.
Continuous Improvement: Analyzing actual field failures and their consequences contributes to a culture of continuous improvement. Management can identify areas for enhancement, refine risk analysis processes, and implement corrective actions.
Root Cause Analysis: Reporting actual field failures and their impacts includes details about root cause analysis and corrective actions taken. This shows the organization’s commitment to addressing problems systematically.
Environmental Responsibility: Field failures can have environmental implications. By including their impact on the environment in the management review, management can assess the organization’s environmental responsibility and compliance.
Resource Allocation: Field failures can lead to unplanned resource allocation for recalls, repairs, replacements, or customer support. Reviewing these failures allows management to make informed decisions about resource allocation.
Decision-Making: Including potential and actual field failures in the management review provides decision-makers with data-driven insights. It enables management to prioritize and allocate resources for risk mitigation and corrective actions.
Learning and Improvement: Field failures provide learning opportunities for the organization. Management can analyze failures to prevent their recurrence, share lessons learned, and enhance the organization’s knowledge base.
Transparency and Accountability: Including field failures in the management review promotes transparency and accountability within the organization. It ensures that top management is aware of potential risks, actual failures, and the organization’s responses.

When presenting potential field failures identified through risk analysis and reporting actual field failures in the management review, provide detailed information about the failures, their impacts, root cause analysis, corrective actions, and any follow-up actions taken. Use visual aids such as tables, graphs, and diagrams to enhance clarity. Discuss how these failures align with the organization’s commitment to quality, safety, regulatory compliance, and environmental sustainability.

Clause 9.3.3.1 Management review outputs

In addition the the requirements given ISO 9001:2015 Clause 9.3.3 Management review output , clause 9.3.3.1 requires that top management to document and implement an action plan when customer performance targets are not met.

please click here for ISO 9001:2015 Clause 9.3.2 Management review inputs outputs

It’s a crucial practice for top management to document and implement an action plan when customer performance targets are not met. This proactive approach helps ensure that any deviations from customer expectations are addressed promptly and effectively. Here’s why documenting and implementing an action plan in such cases is important:

Accountability: Documenting an action plan holds the organization accountable for addressing issues that impact customer performance targets. It demonstrates the commitment of top management to resolving customer-related challenges.
Continuous Improvement: An action plan provides a structured approach to identify root causes of underperformance and implement corrective actions. This contributes to continuous improvement and prevents recurring issues.
Problem Solving: An action plan guides the organization in systematically analyzing the reasons for not meeting customer performance targets. It helps identify underlying issues and provides a framework for finding effective solutions.
Resource Allocation: Documenting an action plan helps allocate necessary resources, including personnel, time, budget, and technology, to address the issues and improve customer performance.
Timely Response: An action plan ensures a timely response to customer-related challenges. This helps prevent customer dissatisfaction and further escalation of issues.
Prevention of Recurrence: By implementing corrective actions based on the action plan, the organization can prevent similar issues from arising in the future, enhancing long-term customer satisfaction.
Communication: Documenting an action plan facilitates clear communication within the organization about the steps to be taken, responsibilities, timelines, and expected outcomes.
Transparency: An action plan demonstrates transparency and commitment to improvement, both internally and externally. It shows that the organization takes customer concerns seriously.
Alignment with Objectives: Implementing an action plan ensures that the organization’s actions are aligned with its objectives of meeting or exceeding customer expectations.
Learning Opportunity: An action plan provides a learning opportunity for the organization. It allows the organization to learn from its mistakes and make informed decisions for future improvements.
Customer Relationships: Addressing issues promptly and effectively through an action plan contributes to building and maintaining positive relationships with customers.
Risk Management: Addressing issues related to customer performance targets through an action plan helps manage risks associated with customer dissatisfaction, contract breaches, and potential financial impacts.

When documenting and implementing an action plan for customer performance targets that are not met, consider the following steps:

Identify the Issue: Clearly define the specific customer performance targets that were not met and the associated issues or challenges.
Root Cause Analysis: Analyze the root causes of the issue to understand why the targets were not met. This may involve data analysis, process evaluation, and stakeholder input.
Develop Corrective Actions: Based on the root cause analysis, develop specific corrective actions that address the identified issues and improve customer performance.
Assign Responsibilities: Clearly assign responsibilities for each corrective action to individuals or teams within the organization.
Set Timelines: Establish realistic timelines for the implementation of each corrective action. Ensure that deadlines are achievable and aligned with customer expectations.
Allocate Resources: Determine the resources required, such as personnel, budget, technology, and training, to implement the corrective actions effectively.
Monitor Progress: Regularly monitor the progress of the action plan to ensure that corrective actions are being implemented as planned.
Measure Results: Assess the impact of the corrective actions on customer performance targets. Determine if the desired improvements are achieved.
Documentation: Document the entire process, including the issue, root cause analysis, corrective actions, responsible parties, timelines, and outcomes.
Communication: Keep stakeholders, including top management, informed about the progress of the action plan and any updates or changes.
Review and Adjust: Periodically review the effectiveness of the action plan. If necessary, make adjustments based on new insights or changing circumstances.
Learning and Improvement: Use the experience gained from the action plan to improve processes, enhance customer relations, and prevent similar issues in the future.

By documenting and implementing an action plan when customer performance targets are not met, top management demonstrates a commitment to customer satisfaction, quality improvement, and the success of the organization’s QMS.

IATF 16949:2016 Clause 10.3.1 Continual improvement

Continual improvement is defined as a recurring activity to increase the ability to fulfill requirements. The ‘ability to fulfill requirements’ refers to both conforming as well as nonconforming processes. Conforming processes can be further improved; and nonconforming processes must be improved by taking corrective action to prevent recurrence. Recurring activity refers to the quality improvements – quality policy and objectives; audit results; analyses of data; etc. Continual improvement is only applicable to processes that are stable and capable (i.e. under control or conforming). It cannot be applied to nonconforming processes. Corrective action must first be taken to bring nonconforming (unstable or non-capable) processes under control, before any continual improvement can be done. The continual improvement process can be conducted by: Significant breakthrough projects that either revise or improve existing processes or lead to new processes. These are usually done by cross-functional teams outside routine operations. Small-step ongoing improvement activities conducted by personnel within existing processes. Use of continual improvement tools include: Quality Policy and Quality objectives. Changes in product, customer base, organization ownership, management, technology, QMS standards, etc., may require changes to your quality policy and objectives. As a tool for continual improvement, it requires top management to review and understand these changes; make changes, if necessary, to the quality policy and objectives and use these changes to continue further improvement of the QMS and customer satisfaction. Audit Results – Results of product, process, process and QMS audits usually provide many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate to communications; information systems; processes; controls; use of resources; technology; etc. The management representative must report these opportunities to top management as included as part of the management review agenda. They can also be reported and reviewed at regular operational meetings, etc. Other Audits – Besides product, process and QMS audits, you might find it very productive to conduct financial; health and safety; environmental; technology; product profitability; social responsibility; information and communication systems audits. You will be amazed at what you will find and improvement opportunities you will uncover. In using ‘analyses of data’ as a tool for continual improvement, use the TGR and TGW approach to classify your data for decision-making. Examples of situations which might lead to improvement projects include: machine set-up, die change, machine changeover times; cycle time; scrap; non value-added use of floor space; variation in product characteristics and process parameters; less than 100% first run capability; process averages not centered on target values; testing requirements not justified by accumulated results; waste of labor and materials; difficult manufacture, assembly and installation of product; excessive handling and storage; etc. Other tools that are often used to continually improve, include: capability studies; design of experiments; evaluation procedure; quality control chart system; risk analysis; SPC; supplier evaluation; test and measurement technology; theory of constraints; overall equipment effectiveness; parts per million (ppm) to achieve zero defects; value analysis; benchmarking; analysis of motion/ergonomics and error-proofing. Ensure that personnel applying these tools are competent and trained Use SPC, new material, tooling, equipment or technology to control and reduce variation in product characteristics and process parameters. Document improvements in drawings, FMEA, control plans, work instructions, etc., and update PPAP. Performance indicators to measure the effectiveness of the continual improvement process may include – quality objectives being met sooner than planned;; achieving and exceeding business and quality objectives; improved efficiency in use of resources; cost reduction; improved product quality; increased C_pk’s; etc.

Clause 10.3.1 Continual improvement

In addition to the requirement given in Clause 10.3 Continual improvement , Clause 10.3.1 requires that the organization to have a documented process for continual improvement which shall include identification of the methodology used, objectives, measurement, effectiveness, and documented information; a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste; and risk analysis (such as FMEA). Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable and meet customer requirements

Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable and meet customer requirements. “Statistically capable” refers to processes that have achieved a level of capability where the variation in their outputs is within acceptable limits. This means that the process is predictable and can consistently produce products that meet specifications. “Stable” processes are those that exhibit consistent and predictable behavior over time, with minimal variability. Stability indicates that the process is under control and not subject to significant fluctuations. In essence, the organization should focus on establishing a solid foundation of stable and capable processes, ensuring that products consistently meet customer requirements. Once this foundation is established, the organization can then shift its focus to continual improvement, seeking ways to further optimize processes, enhance product quality, reduce waste, and achieve higher levels of efficiency and customer satisfaction.This approach aligns with the principles of quality management, including those outlined in IATF 16949, and emphasizes the importance of basing improvement efforts on a solid understanding of process capability, stability, and customer needs. It ensures that improvements are built upon a strong and reliable manufacturing foundation, leading to sustainable and meaningful enhancements.

Having a documented process for continual improvement is a fundamental aspect of an effective quality management system, aligned with standards such as IATF 16949. This process provides a structured framework for identifying, prioritizing, implementing, and evaluating improvements across various aspects of the organization. Here’s how you can establish a documented process for continual improvement:

Process Definition and Scope: Clearly define the scope of the continual improvement process. Determine which areas, processes, and functions within the organization will be subject to improvement efforts.
Leadership Commitment: Obtain commitment and support from top management to ensure that the organization is dedicated to driving continual improvement as a core value.
Cross-Functional Teams: Establish cross-functional improvement teams that include representatives from different departments. These teams will collaborate on identifying and implementing improvement opportunities.
Identification of Improvement Opportunities: Develop a systematic approach for identifying improvement opportunities. This could involve analyzing customer feedback, performance metrics, audits, internal assessments, and benchmarking.
Prioritization and Selection: Evaluate and prioritize the identified improvement opportunities based on factors such as potential impact, feasibility, resource availability, and alignment with strategic goals.
Action Planning: Create detailed action plans for selected improvement initiatives. Specify objectives, strategies, timelines, responsibilities, and required resources for each improvement project.
Implementation and Execution: Execute the action plans, making necessary changes to processes, procedures, or systems. Engage the relevant teams and stakeholders to ensure smooth implementation.
Monitoring and Measurement: Establish key performance indicators (KPIs) to measure the progress and effectiveness of improvement initiatives. Regularly monitor and measure results against established targets.
Review and Evaluation: Conduct periodic reviews of improvement projects to assess their outcomes, identify any deviations, and determine if the desired improvements have been achieved.
Learning and Knowledge Sharing: Encourage a culture of learning and knowledge sharing within the organization. Ensure that insights gained from improvement projects are communicated across teams and departments.
Documentation and Records: Document all aspects of the continual improvement process, including improvement plans, actions taken, results achieved, lessons learned, and any changes made.
Feedback Mechanisms: Establish mechanisms for collecting feedback from employees, customers, and other stakeholders on improvement initiatives. Use feedback to refine processes and drive further enhancements.
Training and Skill Development: Provide training to employees involved in the continual improvement process. Equip them with problem-solving skills, data analysis techniques, and tools for process enhancement.
Integration with Quality Management System: Integrate the continual improvement process with the organization’s overall quality management system. Ensure alignment with other processes such as corrective action, preventive action, and risk management.
Communication and Reporting: Communicate the progress and results of improvement initiatives to all relevant stakeholders. Share success stories and lessons learned to inspire and motivate the organization.

Having a documented process for continual improvement demonstrates your organization’s commitment to achieving excellence, driving innovation, and delivering value to customers. This structured approach helps foster a culture of continuous learning and enhancement, ultimately leading to sustained growth and improved competitiveness.

Methodology for Continual improvement

The process for the identification of the methodology used, objectives, measurement, effectiveness, and documented information in the context of continual improvement is a structured approach to ensure that improvement initiatives are well-defined, measurable, and result in meaningful enhancements. Determine the methodology or approach to be used for the specific improvement initiative. This could include established methodologies like Six Sigma, Lean, PDCA (Plan-Do-Check-Act), DMAIC (Define-Measure-Analyze-Improve-Control), or other suitable frameworks. Define clear and specific objectives for the improvement initiative. What do you aim to achieve through this improvement? Objectives should be aligned with the organization’s strategic goals and customer requirements. Establish measurement criteria or key performance indicators (KPIs) that will be used to assess the success of the improvement initiative. These criteria should be quantifiable, measurable, and relevant to the objectives. Determine how the effectiveness of the improvement initiative will be evaluated. This could involve assessing factors such as cost reduction, cycle time improvement, defect reduction, customer satisfaction enhancement, etc. Create and maintain documented information related to the improvement initiative. This includes action plans, process maps, data analysis, reports, and any other relevant documentation. Involve cross-functional teams in the process to ensure diverse perspectives and expertise. Collaborate with different departments to gather insights and input. Develop a detailed action plan outlining the steps, responsibilities, timelines, and resources required to implement the improvement initiative. Execute the action plan according to the defined methodology. Monitor progress and ensure that tasks are carried out as planned. Collect relevant data and measurements according to the established measurement criteria and KPIs. Use data analysis tools to assess the current state and identify areas for improvement. Evaluate the effectiveness of the improvement initiative based on the measurement criteria. Compare the results to the objectives to determine the level of success achieved. Document the results of the improvement initiative, including before-and-after data, analysis findings, lessons learned, and any challenges encountered. Encourage a culture of continuous learning by sharing insights and experiences gained from the improvement initiative. Use this knowledge to inform future improvement projects. Review the documented information and results with relevant stakeholders. Gather feedback on the process, outcomes, and potential areas for further enhancement. Communicate the outcomes and benefits of the improvement initiative to internal teams and, when applicable, to customers or other external parties. Integrate the methodology identification, objectives, measurement, and effectiveness evaluation into the broader continual improvement process of the organization. By following this process, your organization can ensure that improvement initiatives are well-defined, effectively executed, and result in measurable enhancements that contribute to the organization’s overall goals and success.

Manufacturing process improvement action plan

Incorporating a manufacturing process improvement action plan with a focus on reducing process variation and waste is a proactive step towards enhancing product quality, efficiency, and overall operational excellence. Begin by conducting a thorough assessment of the current manufacturing process. Identify areas where process variation and waste are prominent and affecting product quality, lead times, and resource utilization. Clearly define the objectives of the improvement action plan. Specify the desired outcomes, such as target levels of process variation reduction and waste reduction, and how these align with overall organizational goals. Establish a cross-functional team consisting of experts from different departments, including manufacturing, quality, engineering, and operations. This team will collaborate to design and implement the improvement plan. Collect relevant data on process parameters, variations, defects, and waste generation. Utilize statistical tools and techniques to analyze the data and identify root causes of process variation and waste.Perform a thorough root cause analysis to understand the underlying factors contributing to process variation and waste. Use tools such as fishbone diagrams, Pareto charts, and 5 Whys to identify key factors. Based on the root cause analysis, work with the cross-functional team to redesign and optimize the manufacturing process. Implement changes that reduce sources of variation and waste, and enhance process stability. Implement a system for continuous monitoring and measurement of process parameters, variation levels, and waste generation. Use real-time data to track progress and ensure that improvements are sustained. Standardize the improved process by documenting standard operating procedures (SOPs) and providing training to relevant personnel. Ensure that everyone is aligned with the new process. Integrate quality control measures, such as in-process inspections and quality gates, to detect and address process variations early in the production cycle. Implement waste reduction strategies such as lean principles, 5S (Sort, Set in order, Shine, Standardize, Sustain), and visual management techniques to systematically eliminate waste from the process. Foster a culture of continuous improvement where employees are encouraged to identify and address process variations and waste in their daily work. Provide incentives for innovative ideas and contributions. Establish key performance indicators (KPIs) to measure the success of the improvement action plan. Regularly report progress and outcomes to management and relevant stakeholders. Encourage feedback from employees involved in the process and gather their insights on further improvements. Use lessons learned to refine the process and drive further enhancements. Document all steps of the improvement action plan, including data analysis, root cause findings, process changes, and results achieved. Communicate the plan and outcomes across the organization. Periodically review the effectiveness of the improvement action plan. Make adjustments based on new insights, changing conditions, or shifts in organizational priorities. By implementing a manufacturing process improvement action plan with a focus on reducing process variation and waste, your organization can achieve significant gains in product quality, cost efficiency, and customer satisfaction. This approach aligns with the principles of continual improvement and contributes to the organization’s long-term success.

Risk Analysis:

Integrating risk analysis, such as Failure Mode and Effects Analysis (FMEA), into the continual improvement process enhances your organization’s ability to proactively identify and mitigate potential risks, thereby ensuring more robust and sustainable improvements. As you identify areas for improvement within your processes, products, or systems, also consider potential risks associated with these areas. This can include risks related to process variation, waste, quality, safety, and customer satisfaction.Create a cross-functional team comprising experts from different disciplines. This team will collaborate to perform the FMEA as part of the continual improvement process. Define the scope of the FMEA. Identify the specific process, product, or system that will be analyzed. Clearly outline the boundaries and interfaces of the analysis. List all possible failure modes that could occur within the scope of the analysis. These failure modes represent potential risks or issues that may impact the desired improvement. Evaluate the potential effects or consequences of each identified failure mode. Consider how each failure mode could impact product quality, customer satisfaction, safety, and other critical factors. Assign a severity rating to each failure mode based on the potential impact. Use a predefined scale to rate the severity, with higher ratings indicating more severe consequences. Determine the root causes of each failure mode. Understand why these failure modes might occur and what factors contribute to their occurrence. Assign an occurrence rating to each failure mode to represent the likelihood of its occurrence. Use data, historical records, and expert judgment to determine the likelihood. Assign a detection rating to each failure mode, indicating how likely the failure mode is to be detected before reaching the customer. Lower detection ratings signify a higher likelihood of the failure going undetected. Calculate the Risk Priority Numbers (RPNs) for each failure mode by multiplying severity, occurrence, and detection ratings. Prioritize the failure modes based on their RPNs. Develop mitigation and control measures for high-priority failure modes with elevated RPNs. These measures aim to reduce the severity, occurrence, or improve detection of potential issues. Implement the identified mitigation measures and monitor their effectiveness over time. Adjust and refine the measures as needed based on real-world results. Document the entire FMEA process, including failure modes, severity, occurrence, detection ratings, RPNs, root causes, and mitigation actions taken. Communicate the outcomes and actions to relevant stakeholders. Gather feedback from the team and stakeholders on the effectiveness of the FMEA-based improvements. Use this feedback to refine the continual improvement process and future FMEA analyses Integrate the outcomes of the FMEA into your broader continual improvement initiatives. Use the insights gained from FMEA to guide improvement efforts and ensure that risks are proactively addressed. By incorporating risk analysis like FMEA into the continual improvement process, your organization can identify potential risks early, implement effective control measures, and drive more robust and sustainable improvements. This approach aligns with the principles of quality management and contributes to overall organizational resilience and excellence.

IATF 16949:2016 clause 10.2.6 Customer complaints and field failure test analysis

Customer complaints

In the context of IATF 16949, which is the automotive industry’s quality management standard, the handling of customer complaints is a critical component of the quality management system. Effective management of customer complaints helps organizations address issues, improve products and processes, and enhance customer satisfaction. Here’s how customer complaints are typically managed in compliance with IATF 16949. Establish a formal process for receiving and registering customer complaints. Designate responsible personnel to handle complaint intake and ensure that all relevant information is accurately documented. Classify and categorize customer complaints based on factors such as the nature of the issue, product or service involved, severity, and potential impact on safety and quality. Initiate a comprehensive investigation into the root cause of the complaint. Use methodologies such as the 8D (Eight Disciplines) problem-solving process or other recognized problem-solving approaches. Involve cross-functional teams, including engineering, quality, manufacturing, and relevant stakeholders, to collaboratively analyze the issue and identify its underlying causes. Implement immediate corrective actions to address the identified root cause and prevent recurrence of the issue. Take steps to contain and mitigate the impact of the problem. Maintain open and transparent communication with the customer throughout the investigation and resolution process. Provide timely updates on the progress of corrective actions. If the complaint reveals a design flaw or manufacturing process issue, provide feedback to design and production teams to drive improvements. Develop and implement long-term corrective actions to address systemic issues and prevent similar complaints from occurring in the future. Monitor the effectiveness of implemented corrective actions through ongoing verification and validation. Ensure that the issue has been fully resolved and no further recurrence is observed. Maintain detailed documentation of the entire complaint handling process, including complaint details, investigation findings, corrective actions, and verification results. Analyze customer complaint data to identify trends, patterns, and common issues. Use this analysis to drive continuous improvement efforts. Implement mechanisms to capture customer feedback, whether positive or negative, and integrate this feedback into product development and improvement processes.
Training and Awareness: Provide training to employees involved in handling customer complaints to ensure they are equipped with the necessary skills and knowledge. Include customer complaint management as part of your organization’s internal audit process to verify compliance with IATF 16949 requirements. Effectively managing customer complaints in accordance with IATF 16949 not only ensures compliance with quality standards but also contributes to improved product quality, customer satisfaction, and overall business success in the automotive industry.

Field Failure Analysis

Field failure analysis involves collaboration between customers and suppliers to analyze returned failed components, particularly those with no-fault found reports. It is suitable for the entire supply chain, including original equipment manufacturers (OEM) and suppliers. It provides discrete steps, defined procedures, and a clear allocation of responsibilities.

When a component failure occurs ‘in the field,’ the defective part is replaced, and the manufacturer (OEM) or supplier may request their return to allow analysis. There is often no fault found during the analysis. In the past, suppliers or the OEM took no further action. But that had to change. The objective of the FFA was to establish the reason for removing a field failed part from a vehicle, identify the root cause of the failure, and implement corrective actions. A subsequent process was designed to address the no-fault-found parts once they trigger an agreed threshold.

The steps of the FFA process

Field failure analysis follows an escalating test philosophy to ensure a rigorous analysis, but one that can be economically justified.

Phase #1: Part analysis

The FFA process begins upon receipt of a defective part from the field and involves a part analysis. The part analysis takes place in three discrete steps: standard tests, complaint evaluation, and tests under load.

1a: Standard tests

The standard test begins with a comprehensive visual inspection before testing the component at ambient temperatures and in an environment that mirrors in-service conditions, including loads. All tests must follow accepted test methods and use unambiguous test criteria, with all normal tests fully completed. Identification of a fault is not a reason to prematurely cease testing. The person carrying out the tests should carefully document the process, findings, and observations. Standard and load tests should not damage the inspected part so it can be re-installed into the machine for further testing. This is why destructive testing is avoided (unless the supplier and the customer specifically agree to it).

1.b: Failure complaint evaluation

An explicit fault description must accompany any part received from the field. After completing the standard test, the testing team will evaluate the complaint or fault description, and any faults found are checked for plausibility against the customer’s complaint. If the fault is proven, the FFA process proceeds to a problem-solving process. If no faults are detected or the failure found does not align with the original complaint, the testing team will plan additional specific load tests to elicit the original failure.

1.c: Load tests

Proceeding to the load testing phase assumes the standard tests found no fault, or the identified faults do not accord with the customer complaint. The test plan must be agreed on, based on the component design parameters and requirements specifications. It must ensure the testing is equivalent to the environmental and in-operation conditions, including humidity, speeds, voltages, and physical loads. Extra load parameters should form part of the test plan to evoke the defects highlighted in the complaint.If a fault is proven, the FFA process proceeds to a product-handling procedure, with the component tagged as ‘not in order,’ or N.I.O. Tagging a part as N.I.O does not mean the customer complaint is proven, simply that testing found a fault. Those parts with no proven faults are tagged as ‘in order,’ or I.O., based on part analysis. The I.O. tag does not mean the part is serviceable, simply that testing failed to elicit a fault. If the triggering criteria are met for parts tagged as I.O., the defective part proceeds to the NTF or ‘no trouble found’ phase; if not, the part passes to a product handling procedure.Completing the load tests is an inflection point, determining whether the component proceeds to a product handling procedure as an individual failure or triggers the NTF process to investigate possible systemic or process defects due to the number or importance of the failures.The NTF trigger is an agreed metric between the parties involved, usually the supplier and OEM. It may be an agreed threshold of parts reported as ‘in order’ following the part analysis, based on the number of complaints received from a customer or any faults that arise from a new component or product launch.

Phase #2: The NTF process

The NTF process comprises of three distinct but highly iterative stages, making it incorrect to consider them a linear progression. Instead, you should look at them as three corners of a triangle, in the center of which lies the answer.

2a: Data collection and evaluation

The data collection and evaluation stage involves each party in the NTF process carrying out data collection and evaluation related to their area of responsibility. This stage is wide-ranging and may include failure databases, the geographic specificity of failure, service and repair data, or production process information. Evaluation techniques can include statistical analysis, equipment history, correlations between failure rates and production changes, or failures due to mileage.

2b: System tests

The system tests are a more comprehensive and wider-ranging version of the load tests. They may include involvement from outside testing laboratories, aging tests, functional tests under varying loads, or tests in the vehicle producing the problems. Rather than focus solely on the component, the system tests investigate relationships and active connections within the system.

2c: Process study

The process study investigates interface issues between organizations and systemic problems in programming, diagnosis, or equipment and parts manuals. It may also investigate possible influences from peripheral components that might impact the failure, such as seals, hoses, clamps, or electrical connectors. If the NTF process has failed to identify an issue, all parties must agree whether to continue with further analysis or document and conclude the process. If the NTF process identifies the problem, the FFA proceeds to the problem-solving stage.

Phase #3: Problem solving

The automobile industry uses the 8D method for sustainable problem-solving. However, for this stage, an organization may use any of the root cause analysis process they are familiar with.The 8D method uses the following steps:

Assemble the team
Describe the problem
Contain the problem – isolate from client impact
Carry out a root cause analysis
Plan permanent corrective actions
Implement and validate permanent corrective actions
Prevent recurrence
Recognize team contributions

The OEM will usually initiate the FFA process, as they will receive the warranty returns or defective parts. However, the supplier should begin their part of the process the moment they receive defective parts into their stores’ system. Under the FFA procedure, a supplier has strict responsibilities to quarantine, document, track, and preserve the defective parts to ensure a rigorous chain of custody.The FFA procedure is collaborative and depends on the context of the failure, with all parties agreeing on who will lead the process and who will take part, as well as the responsibilities and deliverables of all parties. Much of the process will require the involvement of all parties, with one nominated to take the lead. The data management and collection process underpins the integrity of the FFA process. This process revolves around two principles:

The first is a rigorous and documented chain of custody and evidence preservation management system that starts upon receipt of the part from the field and does not end until its disposal.
The second principle is that once a part failure is found, at any point in the FFA process, it is declared defective regardless of whether the failure can or cannot be reproduced.

To ensure a meaningful analysis, upon receipt of a defective part, the supplier or OEM must implement a system of traceability that will follow the part through the FFA and which may be examined at any point to understand the component’s test status. The item must be reliably marked and retained in a quarantine area to prevent it from being returned to service, sold, or destroyed. To prevent affecting the investigation process, the supplier or OEM must exercise care not to clean, modify, or damage the component, unless such cleaning or modification forms part of the formal FFA procedure agreed upon by the parties.The outlined field failure analysis process provides a useful template for other industries and manufacturers who wish to stop spending money on warranty returns and product recalls. Implementing such a strictly controlled and documented process removes subjectivity and external influence from product investigations and testing. It provides a scientific and systematic approach for applying corrective actions and building quality into existing products.

10.2.6 Customer complaints and field failure test analysis

The organization are to perform analysis on customer complaints and field failures, including any returned parts, and initiate problem solving and corrective action to prevent recurrence. Where requested by the customer, this shall include analysis of the interaction of embedded software of the organization’s product within the system of the final customer’s product. The organization shall communicate the results of testing/analysis to the customer and also within the organization.

Customer Complaint

Performing analysis on customer complaints and initiating problem-solving and corrective action is a fundamental practice in quality management, especially in compliance with standards like IATF 16949. This approach helps organizations identify the root causes of issues, implement effective solutions, and prevent the recurrence of similar problems. Here’s how the process can be structured:

Complaint Analysis: Collect and gather detailed information about the customer complaint. This includes the nature of the issue, product details, circumstances, and any supporting evidence provided by the customer.
Problem Identification: Analyze the complaint data to identify the specific problem or nonconformity that led to the customer’s concern. Determine whether the issue is related to design, production, service, or other aspects.
Root Cause Analysis: Perform a thorough root cause analysis using appropriate methodologies such as the 5 Whys, Fishbone diagrams (Ishikawa), Fault Tree Analysis, or Failure Mode and Effects Analysis (FMEA). Identify the underlying factors contributing to the issue.
Cross-Functional Collaboration: Involve relevant teams and departments, such as engineering, manufacturing, quality, and customer service, in the analysis process. Collaborative efforts enhance the accuracy of root cause identification.
Immediate Corrective Action: Implement immediate corrective actions to address the identified root cause and prevent the issue from affecting other products or processes. This may involve containment measures to prevent further occurrences.
Long-Term Corrective Action: Develop and implement long-term corrective actions that address systemic issues and prevent the recurrence of similar problems. Focus on process improvements, design enhancements, or training.
Validation and Testing: Verify the effectiveness of the corrective actions through testing or validation. Ensure that the implemented solutions successfully address the root cause and produce the desired results.
Documentation and Reporting: Document the entire analysis process, root cause findings, corrective actions taken, and their outcomes. Maintain accurate records for future reference, audits, and continuous improvement.
Communication with Customer: Maintain transparent and consistent communication with the customer. Provide updates on the analysis progress, actions taken, and expected resolutions. Seek their feedback and input.
Feedback Loop: Integrate the lessons learned from the analysis and corrective action into your organization’s continuous improvement efforts. Apply insights to enhance product design, manufacturing processes, and overall quality.
Training and Skill Development: Ensure that employees involved in the analysis and corrective action process have the necessary skills and training to perform effective root cause analysis and problem-solving.
Audit and Verification: By systematically performing analysis on customer complaints, identifying root causes, and implementing appropriate corrective actions, the organization not only resolves immediate concerns but also strengthens its overall quality management system. This approach aligns with the principles of IATF 16949 and contributes to delivering high-quality products and services that meet or exceed customer expectations.

Field failure

Performing analysis on field failure test results and initiating problem-solving and corrective action is a crucial aspect of quality management and continuous improvement, particularly in industries like automotive where product reliability and safety are paramount. Here’s how the process can be structured:

Field Failure Test Analysis: Gather data and information from field failure tests, which involve real-world conditions and usage scenarios. This data can include failure rates, patterns, and other relevant information.
Data Collection and Segmentation: Collect detailed data on field failures, including product details, failure modes, locations, and environmental conditions. Segment the data based on factors such as product models, batches, or geographical regions.
Root Cause Analysis: Analyze the field failure data to identify root causes of the failures. Use techniques like the 5 Whys, Fishbone diagrams, or Failure Mode and Effects Analysis (FMEA) to determine underlying factors.
Cross-Functional Collaboration: Collaborate across departments, including engineering, manufacturing, quality, and testing, to collectively analyze the field failure data. Different perspectives can lead to more accurate root cause identification.
Immediate Corrective Action: Implement immediate corrective actions to address the root causes of identified failures. Focus on containing and preventing further occurrences of the same issues.
Long-Term Corrective Action: Develop and implement long-term corrective actions that address systemic issues to prevent recurrence. This may involve design changes, process improvements, or material upgrades.
Validation and Testing: Verify the effectiveness of corrective actions through additional testing or validation. Ensure that the implemented solutions successfully resolve the identified root causes.
Documentation and Reporting: Document the entire analysis process, root cause findings, corrective actions taken, and validation results. Maintain accurate records for future reference and audits.
Communication and Reporting: Communicate the analysis findings, corrective actions, and outcomes to relevant stakeholders, including management, design teams, and customers if necessary.
Feedback Loop and Continuous Improvement: Incorporate the lessons learned from the field failure test analysis into your organization’s continuous improvement efforts. Use insights to drive enhancements in product design, manufacturing, and quality control.
Training and Skill Development: Provide training to employees involved in the analysis and corrective action process to ensure they have the necessary skills for effective root cause analysis and problem-solving.
Audit and Verification: Include the field failure test analysis and corrective action process in your internal audit program to verify compliance with quality standards and the organization’s quality management system.

By systematically analyzing field failure test results, identifying root causes, and implementing appropriate corrective actions, the organization can enhance product reliability, safety, and customer satisfaction. This approach aligns with the principles of quality management and contributes to delivering products that meet or exceed customer expectations in industries like automotive.

Embedded Software

When requested by the customer, conducting an analysis of the interaction of embedded software of the organization’s product within the system of the final customer’s product is an important step to ensure that the software functions correctly and seamlessly within the larger context. This is particularly relevant in industries where embedded software plays a critical role in the operation, functionality, and safety of products. Here’s how you can approach this requirement:

Customer Requirement Clarification: Clearly understand and document the specific customer request for analyzing the interaction of embedded software within the final customer’s product system. Seek clarification if needed to ensure alignment.
Identify Scope and Boundaries:Define the scope of the analysis, including the embedded software components to be considered, the final customer’s product system, and any specific interfaces or interactions to be studied.
Collaboration with Customer: Establish open communication and collaboration with the customer to gather relevant information about the final product system, its requirements, interfaces, and expected behavior.
Embedded Software Assessment: Evaluate the embedded software components in terms of their compatibility, functionality, and performance within the larger system. Identify any potential points of interaction, integration challenges, or areas of concern.
Interoperability Testing: Perform interoperability testing to verify that the embedded software interacts as intended with other components of the final customer’s product system. This may involve functional, interface, and performance testing.
Risk Assessment: Assess the potential risks associated with the embedded software’s interaction within the larger system. Identify any potential vulnerabilities, compatibility issues, or risks that may arise.
Root Cause Analysis: If any issues or discrepancies are identified, conduct root cause analysis to determine the underlying causes of the problems. This may involve analyzing software code, system configurations, or communication protocols.
Corrective and Preventive Actions: Develop and implement corrective actions to address any identified issues or risks. Focus on ensuring that the embedded software performs optimally within the final product system.
Validation and Verification:Validate the effectiveness of corrective actions through testing and verification. Ensure that the embedded software’s interaction with the larger system has been improved and optimized
Documentation and Reporting: Document the entire analysis process, including findings, actions taken, testing results, and validation outcomes. Maintain detailed records for future reference and audits.
Customer Communication: Provide the customer with comprehensive reports and updates on the analysis process, outcomes, and any actions taken to enhance the embedded software’s performance within their product system.
Continuous Improvement: Incorporate the insights gained from the analysis into your organization’s continuous improvement efforts. Apply lessons learned to enhance software design, development processes, and system integration.
Training and Expertise:Ensure that the team members responsible for conducting the analysis have the necessary expertise in software engineering, system integration, and quality management.

By conducting a thorough analysis of the interaction of embedded software within the final customer’s product system, the organization demonstrates its commitment to meeting customer requirements and ensuring the reliable and effective operation of its products. This approach aligns with the principles of quality management and customer satisfaction, contributing to the organization’s success in delivering high-quality products with embedded software components.

Communicate the results of testing/analysis

Communicating the results of testing and analysis to both the customer and within the organization is a crucial aspect of quality management and transparency. Effective communication ensures that all relevant stakeholders are informed about the outcomes, allowing for informed decision-making, continuous improvement, and alignment with customer expectations. Here’s how you can approach this communication process:

Customer Communication: Prepare a comprehensive report detailing the results of the testing or analysis. The report should include clear and concise information about the purpose of the analysis, methodologies used, findings, any identified issues, corrective actions taken, and validation outcomes. Tailor the communication to the customer’s needs and preferences. Provide the information in a format that is easily understandable and relevant to the customer’s perspective.
Timely Updates: Communicate the results in a timely manner to ensure that the customer is promptly informed about the outcomes. Timeliness is especially important if the analysis reveals any critical issues that may impact the customer’s operations or decisions.
Transparency and Accuracy: Be transparent and honest in presenting the results, both positive and negative. Accurate reporting builds trust and credibility with the customer.
Clarification and Q&A: Be available to address any questions or concerns the customer may have about the testing/analysis results. Provide clarification as needed to ensure that the customer fully understands the findings and implications.
Documentation Sharing: Provide the customer with copies of the detailed analysis report, as well as any relevant documentation such as test protocols, validation results, and corrective action plans.
Internal Communication: Within the organization, disseminate the results of testing/analysis to relevant departments and teams. This ensures that all stakeholders are aware of the outcomes and can contribute to follow-up actions and improvements.
Cross-Functional Collaboration: Engage cross-functional teams within the organization to share the results. This may involve quality, engineering, manufacturing, design, and other relevant departments.
Learning and Improvement: Encourage internal discussions and meetings to review the results and identify opportunities for improvement. Use the insights gained from the analysis to drive continuous improvement efforts.
Action Plans: Develop action plans based on the analysis results, whether it involves implementing corrective actions, making design improvements, or enhancing testing methodologies.
Training and Awareness: Provide training and awareness sessions within the organization to ensure that employees understand the significance of the analysis results and their role in implementing follow-up actions.
Documentation and Records: Maintain accurate and well-organized records of the testing/analysis results, communication with the customer, and internal discussions. Proper documentation supports accountability and auditability.
Feedback Loop: Establish a feedback loop with the customer to ensure that they are satisfied with the communication and that the results align with their expectations.

By effectively communicating the results of testing and analysis both to the customer and within the organization, you demonstrate a commitment to transparency, accountability, and continuous improvement. This approach aligns with the principles of quality management and contributes to building strong relationships with customers and internal stakeholders.

IATF 16949:2016 Clause 10.2.5 Warranty management systems

Warranty is a statement of assurance or undertaking issued by the manufacturer of a product concerning the performance of the product and parts supplied by him by way of sale transaction to the customer, for a certain period as stated in the Warranty Card accompanying the product. In other words, it is a performance guarantee for the product given by the manufacturer. In case of any poor performance due to the nonperformance of any part or defect in any part of the product, will be made good by the supplier/manufacturer with either replacement of the part or product or repair of the product.Warranty Management is today a function of Service Parts Management Stream in the organization.Service Parts Management Teams and structure are the Service Support Delivery owners and function as primary contact points with the customer. At the first level Service, support teams comprise of Customer Desk, which is the first point contact for the customers to register the service request. Technicians and Engineers as front end site supports and second point contacts to the customers. Parts Support Managers oversee the functioning of the operations and take responsibility to close calls and for delivery performance.

Warranty Management and Claims Processing System are driven by the Internet and e-commerce enabled system application that generally consists of the following modules:

Service Warranty Database and Tracker (Database information uploaded from Sales Module)
Service Request Registration, authorization, service job ticket issue, job ticket closure & Report functions.
Parts procurement request, parts issue authorization
Parts Inventory Management, Purchase Order Management, Repair Management, Vendor Management etc.

Parts Procurement and Logistics may be handled by a single department or by separate teams depending upon the volume of business and the management structure. These functions manage parts procurement functions, inbound logistics, parts warehousing and distribution on the outbound cycle. Reverse Logistics functions managed by the team involve – Parts collection, parts segregation, inventory holding of defective parts, parts repair, warranty replacement with OE manufacturer, Re-Export, and Waste disposal or Scrapping functions.

IPTV (en. Incidents Per Thousand Vehicles)
Also known as the C1000. This indicator determines the number of problems reported by final customers visiting the dealer stations. This does not automatically mean the replacement of components. In this case dealer can for example, only update the software, lubricate interface elements, or perform their additional tightening. The starting point for defining the above-mentioned indicator is a joint work which is carried out by the customer’s engineering and the organization of the reliability plan, which corresponds to the implementation of APQP point 1.4. Product and process assumptions.

TF (Technical Factor – %)
Defines the percentage share of the organization’s financial responsibility for the parts replaced by the dealer that are covered by the warranty period. From the supplier’s point of view, this is a key indicator that directly translates into poor quality costs. Defining its value should start immediately after SOP (start of production) with the analysis of the first parts. Usually the first meetings with clients regarding defining of Technical Factor take place a few months after the project is launched. In this case is already analyzed several dozen parts (of course, it can be more which is more advantageous for the organization). To the final evaluation is taken into account:

the number of parts analyzed in a given period
number of parts for which a defect can be assigned for supplier responsibility
the number of parts for which no defect from final customer has been confirmed

It is also worth remembering that TF is not an indicator that is defined once. Depending on the achieved quality performance, this value may be reduced (in case of actions implemented by the organization for identified defects) or increased. Second case will be related to chronic problem assigned to the process, subcomponents or design. Such issue should be analysed in automotive warranty management activity by organization with big attention.

NTF (No trouble found)
No confirmation of the defect. The term used when analyzing warranty returns, for which, after performing standard tests, no defects indicated by the end user were found. Depending on the customer (OEM) additional requirements related to NTF may be applied.

Months in Service (MIS)
Defined as the time period during which the vehicle is used by the end customer. The usual assumption is that 30 days of use is equivalent to the index unit (30 days = 1.0 MIS). When working with a Ford customer, it is worth remembering that it is referred to as TIS: Time-In-Service. The most popular time periods are: 3 months (3 MIS) when the incident occurred, counting from the date of vehicle purchase by the end customer until issue reporting to the dealer, 12 (12 MIS) and 24 (24 MIS) months. Nevertheless, customers such as VW, GM and Ford give the opportunity to see the performance even for one month.

In summary, each person in the organization who is responsible for managing warranty returns should familiarize themselves with the above terms in order to correctly understand the links between them and identify their impact on the potential financial invoices.

10.2.5 Warranty management systems

When the organization is required to provide warranty for their product, the organization must implement a warranty management process. The organization shall include in the process a method for warranty part analysis, including NTF (no trouble found). When specified by the customer, the organization shall implement the required warranty management process.

An automotive warranty management system is a structured and systematic approach used by automotive manufacturers, suppliers, and service providers to manage warranty-related processes, claims, data, and customer interactions. This system helps ensure that products meet quality standards, provides effective customer support, and addresses warranty claims efficiently. Here are the key components and functions of an automotive warranty management system:

Warranty Policy and Guidelines: Define the warranty terms, conditions, and coverage for automotive products. Establish guidelines for handling warranty claims, including what is covered, claim submission deadlines, and customer responsibilities.
Claims Management: Receive, process, and manage warranty claims from customers, dealerships, or other stakeholders. Verify claim validity, assess the nature of defects, and determine whether the claim is eligible for reimbursement or repair.
Data Collection and Analysis: Collect and analyze warranty data to identify trends, patterns, and recurring issues. Use data insights to improve product design, manufacturing processes, and overall quality.
Supplier Collaboration: Collaborate with suppliers to track and address issues related to defective components or materials. Work together to identify root causes and implement corrective actions.
Customer Support: Provide efficient and responsive customer support for warranty-related inquiries, claims submission, and dispute resolution. Keep customers informed about the status of their claims.
Documentation and Records: Maintain detailed records of warranty claims, including customer information, product details, defect descriptions, repair actions, and claim outcomes.
Repair and Replacement: Coordinate and manage repair or replacement activities for defective products. Ensure that repairs are performed correctly and that replacement parts meet quality standards.
Communication Channels: Establish clear communication channels for customers, dealerships, and other stakeholders to submit warranty claims, seek assistance, and provide feedback.
Escalation and Approval: Define escalation procedures for handling complex or high-value warranty claims. Ensure proper authorization and approval processes for claims resolution.
Reporting and Analytics: Generate reports and dashboards that provide insights into warranty trends, costs, claim processing times, and other key performance indicators.
Continuous Improvement: Use warranty data and analysis to drive continuous improvement in product design, manufacturing processes, and quality control.
Regulatory Compliance: Ensure compliance with relevant automotive industry regulations, standards, and laws related to warranty coverage, consumer protection, and data privacy.
Integration with Quality Management: Integrate the warranty management system with quality management processes, such as root cause analysis, corrective and preventive actions, and process improvement initiatives.

An effective automotive warranty management system helps organizations enhance customer satisfaction, reduce warranty costs, identify quality improvement opportunities, and strengthen their reputation within the automotive industry. It aligns with the principles of quality management, customer focus, and continuous improvement, supporting the organization’s commitment to delivering reliable and high-quality automotive products and services.

Warranty part Analysis

Including warranty part analysis in the automotive warranty management process is essential for identifying root causes of product failures, improving product quality, and effectively managing warranty claims. This analysis involves a systematic examination of warranty-related data, including information about defective parts, to gain insights into the underlying issues that lead to warranty claims. Here’s how you can integrate warranty part analysis into your warranty management process:

Data Collection and Aggregation: Gather comprehensive data on warranty claims, including information about the specific parts or components that have experienced failures. Collect data related to part numbers, quantities, failure descriptions, dates of failure, and customer feedback.
Categorization and Segmentation: Categorize warranty claims based on the type of parts or components that are failing. Segregate claims by part number, product model, production batch, or any other relevant criteria.
Root Cause Analysis: Perform thorough root cause analysis on each category of warranty parts. Use techniques such as the 5 Whys, Fishbone diagrams (Ishikawa), Failure Mode and Effects Analysis (FMEA), and statistical analysis to identify underlying causes of failures.
Trend Identification: Analyze warranty part data to identify trends and patterns across different parts or components. Look for common failure modes, recurrence rates, and potential systemic issues.
Supplier Involvement: Collaborate with suppliers to investigate and understand potential defects in the supplied parts. Share warranty data and analysis to jointly identify root causes and implement corrective actions.
Quality Improvement: Based on the analysis, develop and implement corrective and preventive actions to address the identified root causes. Improve part design, manufacturing processes, quality control, and materials to prevent future failures.
Feedback Loop: Establish a feedback loop between warranty part analysis and the product development process. Share insights from warranty data with design and engineering teams to inform design improvements and modifications.
Documentation and Reporting: Document the findings of warranty part analysis, including root causes, corrective actions, and outcomes. Generate reports and dashboards that communicate trends and improvement initiatives.
Continuous Monitoring: Continuously monitor the effectiveness of implemented corrective actions. Track changes in warranty part performance over time to ensure sustained improvement.
Knowledge Sharing: Share insights and lessons learned from warranty part analysis across the organization. Disseminate information to relevant departments, including manufacturing, engineering, and quality assurance.
Training and Skill Development: Provide training to employees involved in warranty part analysis to ensure they have the necessary skills and knowledge to perform effective root cause analysis and data interpretation.
Alignment with Quality Objectives: Ensure that the outcomes of warranty part analysis align with the organization’s quality objectives and contribute to the overall improvement of product quality and customer satisfaction.

By integrating warranty part analysis into the warranty management process, the organization can proactively address product failures, reduce warranty costs, enhance customer satisfaction, and drive continuous improvement in product design and manufacturing processes. This approach supports the organization’s commitment to delivering high-quality automotive products and services and aligns with the principles of IATF 16949 and other quality standards.

NTF (No Trouble Found)

Incorporating NTF (No Trouble Found) cases into the automotive warranty management process is important to effectively handle warranty claims where no identifiable defects or issues are found with the claimed product. Handling NTF cases systematically helps maintain customer satisfaction, reduce unnecessary costs, and improve the overall warranty management process. Here’s how you can include NTF cases in your warranty management process:

Clearly identify and segregate warranty claims that fall under the category of NTF. These are cases where no actual defects or issues are identified upon investigation.
Thoroughly document the customer’s complaint and description of the issue. Capture all relevant details to ensure a complete understanding of the reported problem.
Conduct an initial assessment of the claimed product to verify the reported issue. This may involve basic inspections, tests, or diagnostics to determine if any visible or obvious problems exist.
Maintain open and transparent communication with the customer throughout the process. Inform them of the assessment results and the steps being taken to investigate further.
If no immediate issues are found, conduct a more detailed analysis involving specialized testing, diagnostics, or collaboration with relevant technical teams.
Apply root cause analysis methodologies to explore potential underlying causes of the reported issue, even if they are not immediately apparent.
If applicable, involve suppliers in the investigation to ensure that the reported issue is not related to components or parts they have supplied.
Perform validation testing under various conditions to replicate the reported problem and determine if it can be reproduced.
If the claimed product was initially assessed by a dealership or service center, collaborate with the Dealerships to gather additional insights and observations.
Provide feedback and training to service technicians, dealerships, and personnel involved in diagnosing and handling NTF cases. Enhance their ability to accurately assess and address such situations.
Maintain detailed records of NTF cases, including the steps taken, analysis results, customer interactions, and any follow-up actions.
Educate customers about the possibility of NTF cases, explaining that complex systems may exhibit intermittent or difficult-to-replicate issues.
In cases where no defects are found, consider offering compensation, discounts, or additional support to the customer to maintain a positive relationship.
Analyze NTF cases as part of your overall warranty data analysis to identify trends, improve diagnostic processes, and enhance overall product quality.

By including NTF cases in your warranty management process, you demonstrate a customer-focused approach to addressing reported issues, even when no immediate defects are found. This approach contributes to improved customer satisfaction, efficient use of resources, and ongoing enhancement of your organization’s quality management efforts in the automotive industry.

Customer specified Warranty Management Process

When a customer specifies specific requirements for the warranty management process, it is imperative for the organization to implement and adhere to these requirements. This demonstrates a commitment to meeting the customer’s expectations and ensuring that warranty-related processes align with the customer’s preferences. Review and analyze the customer’s specified warranty management process in detail. Ensure a clear understanding of their expectations, guidelines, and any unique requirements they have outlined. Document the customer-specified warranty management process, including all relevant details, instructions, and specific steps to be followed. Map out the customer-specified process and integrate it with your existing warranty management framework, if applicable. Identify points of alignment and potential gaps. Allocate the necessary resources, personnel, and tools to effectively implement the customer-specified process. Ensure that the required skills and competencies are in place. Customize workflows, procedures, and documentation to match the customer’s requirements while ensuring they integrate seamlessly with your overall quality management system.Provide training to employees involved in the warranty management process to ensure they understand and can effectively implement the customer-specified requirements. Facilitate open communication about the new process. Engage in ongoing communication with the customer to clarify any ambiguities, seek clarification, and address any questions or concerns. Validate the implementation of the customer-specified warranty management process through pilot testing or trial runs. Ensure that it functions as intended and produces the desired outcomes. Seek feedback from both internal stakeholders and the customer regarding the implementation of the specified process. Use feedback to identify areas for improvement and make necessary adjustments. Maintain comprehensive documentation of the implementation process, any changes made, and the outcomes achieved. Keep records of any communication with the customer related to the process. Continuously monitor the performance and effectiveness of the customer-specified warranty management process. Track key performance indicators and customer satisfaction metrics. Ensure that the implemented process is audited as part of your quality management system’s internal audit process to verify compliance with the customer’s requirements. Be prepared to adapt and adjust your processes as needed based on the customer’s feedback and changing requirements over time. By diligently implementing the customer-specified warranty management process, the organization not only meets the customer’s expectations but also enhances its reputation as a reliable and customer-focused partner. This approach fosters strong customer relationships, drives customer satisfaction, and contributes to the organization’s success in the automotive industry.

IATF 16949:2016 Clause 10.2.4 Error-proofing

Please click here for more on Error-proofing.

Error-proofing is a means to prevent the manufacture or assembly of nonconforming product. All people make mistakes. Mistakes are inadvertent errors and arise through human fallibility. We all occasionally forget things and we can either make actions error- proof in order that they can only be performed one way or we can provide signals to remind us of what we should be doing. The terms fool-proofing and Poka-Yoke (coined by Shigeo Shinto) are also used to describe the same concepts. Error-proofing can be accomplished by product design features in order that the possibility of incorrect assembly, operation, or handling is avoided. In such cases the requirements for mistake-proofing need to form part of the design input requirements for the part. Error-proofing can also be accomplished by process design features such as sensors to check the set-up before processing, audible signals to remind operators to do various things. However, signals to operators are not exactly mistake-proof; only mechanisms that prevent operations commencing until the right conditions have been set are proof against mistakes. In cases where computer data-entry routines are used, mistake-proofing can be built into the software such that the operator is prompted to make decisions before irreversible actions are undertaken. In both cases the Design FMEA and Process FMEA should be analyzed to reveal features that present a certain risk which can be contained by redesign with error-proofing features.Error-proofing involves designing processes and systems in a way that prevents errors, defects, and mistakes from occurring or detects them immediately when they do occur. The goal of error-proofing is to minimize the potential for errors to impact product quality, customer satisfaction, and overall process efficiency. Here’s how error-proofing is implemented within the framework of IATF 16949:

Analyze processes, workflows, and activities to identify potential sources of errors or defects. This could involve reviewing historical data, conducting risk assessments, and involving cross-functional teams.
Implement measures that prevent errors from happening in the first place. This might include redesigning processes, improving work instructions, automating tasks, and incorporating fail-safes.
Use visual cues and indicators to guide operators through processes, reducing the risk of errors. Color coding, signage, labels, and visual instructions can help ensure correct actions are taken.
Design tools, components, and equipment in a way that only allows correct assembly or usage. For instance, components that can only fit in one orientation or shape can help prevent assembly errors.
Develop standardized work procedures and checklists that guide operators through each step of a process. This minimizes the likelihood of omitting critical steps or making mistakes.
Incorporate sensors, alarms, and detectors that alert operators when errors occur. This can include detecting missing components, incorrect settings, or deviations from specifications.
Implement Andon systems that allow operators to immediately signal when an error or abnormality is detected. This prompts swift corrective action and prevents the progression of defects.
Utilize automation and robotics to perform tasks that are highly repetitive or prone to errors. Automated systems can consistently perform tasks without the risk of human error.
Ensure that operators receive proper training and skill development to perform tasks accurately. Skilled operators are less likely to make errors.
If errors do occur, conduct root cause analysis to identify the underlying factors that led to the error. This helps implement targeted corrective actions to prevent future occurrences.
Continuously evaluate the effectiveness of error-proofing measures and seek opportunities for further improvement. Incorporate lessons learned into the organization’s quality improvement initiatives.

Error-proofing is a proactive approach to quality management that aligns with the principles of IATF 16949. By preventing errors and defects from occurring, organizations can enhance product quality, customer satisfaction, and overall process efficiency. It also contributes to a culture of continuous improvement and supports the organization’s commitment to delivering high-quality products and services in the automotive industry.

Clause 10.2.4 Error-proofing

The organization must have a documented process to determine the use of appropriate error-proofing methodologies. Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test frequencies shall be documented in the control plan. The process shall include the testing of error-proofing devices for failure or simulated failure. Records shall be maintained. Challenge parts, when used, shall be identified, controlled, verified, and calibrated where feasible. Error-proofing device failures shall have a reaction plan.

In the context of the automotive industry and IATF 16949, the use of appropriate error-proofing methodologies is essential to ensure the highest level of quality, safety, and reliability in products and processes. Error-proofing, also known as mistake-proofing or poka-yoke, aims to prevent errors and defects from occurring or to detect them at an early stage. Here are some commonly used error-proofing methodologies that are relevant to the automotive industry:

Visual Management and Signage:
- Implement visual cues, color coding, labels, and signs to guide operators through correct assembly, usage, and processes. Clear visual indicators help prevent errors and promote standardized practices.
Checklists and Standardized Work:
- Develop standardized work instructions and checklists that outline each step of a process. Operators follow these instructions to ensure consistency and accuracy.
Physical Design and Geometry:
- Design components, parts, and tools in a way that ensures they can only fit or be assembled in the correct orientation or sequence. This prevents incorrect assembly.
Error Detection Sensors and Alarms:
- Install sensors and alarms that detect deviations from specified conditions or tolerances. Alarms alert operators when anomalies occur, allowing for immediate corrective action.
Andon Systems:
- Implement Andon systems that allow operators to raise alerts or signals when errors or abnormalities are detected. This prompts quick intervention and prevents further defects.
Automated Guided Vehicles (AGVs):
- Use AGVs or robotic systems to transport materials or products within the manufacturing facility. AGVs can be programmed to follow specific routes and avoid collisions.
Automated Inspection Systems:
- Employ automated inspection equipment, such as vision systems or automated measuring devices, to check product dimensions, tolerances, and quality characteristics.
Error-Proofing through Tooling:
- Design tools, jigs, and fixtures that prevent incorrect assembly or usage. For example, using unique tooling that fits only in the correct orientation.
Electronic Interlocks:
- Use electronic interlocks that prevent certain actions or operations unless specific conditions are met. This can include safety interlocks in equipment or systems.
Error-Proofing in Software and Programming:
- Implement software-based error-proofing in computerized systems and programs. Use algorithms and logic to prevent invalid inputs or actions.
Training and Skill Development:
- Provide comprehensive training to operators to ensure they understand the importance of error-proofing methodologies and how to effectively use them.
Root Cause Analysis and Continuous Improvement:
- Regularly conduct root cause analysis to identify systemic issues and areas where error-proofing measures can be enhanced. Use lessons learned for continuous improvement.

By integrating these error-proofing methodologies into automotive manufacturing processes, organizations can enhance product quality, reduce defects, improve efficiency, and mitigate risks. These approaches align with the requirements of IATF 16949 and contribute to the overall success of the quality management system in the automotive industry.

Documentation of error-proofing methods

It’s important to document the details of error-proofing methods used for different processes. This documentation helps ensure consistent implementation, traceability, and compliance with quality standards. Here’s how you can effectively document error-proofing methods within the process risk analysis (such as PFMEA) and the control plan:

Process Risk Analysis (e.g., PFMEA – Process Failure Mode and Effects Analysis):
- Within the PFMEA, identify the specific steps or processes where error-proofing methods will be applied. These methods should align with the identified failure modes and potential risks.
- Clearly describe the error-proofing method being used. Explain how it prevents or detects errors, defects, or potential failures. Provide details about the design, mechanism, or function of the error-proofing measure.
- Document the methodology used to implement the error-proofing measure. This could include design changes, visual cues, automation, sensors, or any other relevant approach.
- Specify how often the error-proofing method will be tested or validated to ensure its effectiveness. Outline the criteria for passing the validation tests.
- Create a clear linkage between the error-proofing method identified in the PFMEA and its corresponding entry in the control plan.
Control Plan:
- Within the control plan, create a dedicated entry for each error-proofing method identified in the PFMEA.
- Describe the error-proofing method in detail, including its purpose, design, implementation, and how it contributes to preventing or detecting errors.
- Document the planned test frequencies for validating the error-proofing method. Specify when and how these tests will be conducted.
- Assign responsibility for monitoring, testing, and maintaining the effectiveness of the error-proofing method. Ensure that the necessary resources, equipment, and personnel are allocated.
- Include a reference or link to the corresponding entry in the PFMEA where the error-proofing method is documented.
- Document the results of testing and validating the error-proofing method. If applicable, indicate whether the method has passed the validation criteria.
Continuous Improvement:
- Provide a mechanism for documenting any improvements or updates made to the error-proofing method based on lessons learned or changes in process conditions.

By documenting error-proofing methods in both the process risk analysis (PFMEA) and the control plan, the organization ensures that these measures are systematically implemented, monitored, and maintained. This documentation contributes to the organization’s ability to prevent errors, defects, and failures, ultimately enhancing product quality and customer satisfaction in the automotive industry.

Testing of error-proofing devices

Testing error-proofing devices for failure or simulated failure is a critical step in ensuring the effectiveness and reliability of these devices in preventing or detecting errors. By conducting such testing and maintaining records, the organization can verify that error-proofing measures are functioning as intended and can promptly address any issues that may arise. Here’s how you can incorporate testing of error-proofing devices into your quality management process:

Test Plan Development:Create a comprehensive test plan that outlines the testing procedures, methods, and criteria for evaluating error-proofing devices for failure or simulated failure.
Device Identification:Clearly identify the error-proofing devices that will be subjected to testing. These devices should correspond to the ones documented in your process risk analysis (such as PFMEA) and control plan.
Test Scenarios: Define various test scenarios that simulate potential failures or errors that the error-proofing devices are designed to prevent or detect. These scenarios should represent realistic conditions that the devices may encounter during normal operations.
Testing Procedures: Outline step-by-step procedures for conducting the tests. This should include instructions for simulating failures, triggering the error-proofing devices, and observing their responses.
Data Collection and Documentation: During testing, collect detailed data on the performance of the error-proofing devices under different failure conditions. Document the test results, observations, and any anomalies encountered
Pass/Fail Criteria: Define clear pass/fail criteria for each test scenario. Determine what constitutes a successful response from the error-proofing device and what indicates a failure.
Records Maintenance: Maintain comprehensive records of the testing activities, including test plans, test results, observations, and any corrective actions taken based on the outcomes.
Validation and Verification: After testing, validate and verify the error-proofing devices’ ability to prevent or detect errors. Confirm that the devices function as intended and align with the organization’s quality objectives.
Corrective Actions: If any issues or failures are identified during testing, initiate corrective actions to address the root causes and ensure the devices are functioning correctly.
Continuous Improvement:Use insights gained from testing to drive continuous improvement of error-proofing devices, processes, and testing methodologies.
Review and Approval: Ensure that the results of testing and any modifications to error-proofing devices are reviewed and approved by relevant stakeholders, including quality assurance and management.
Integration with Documentation: Link the testing records to the corresponding entries in your process risk analysis (such as PFMEA) and control plan. This provides a clear traceability of testing efforts.

By systematically testing error-proofing devices for failure or simulated failure, and maintaining comprehensive records of these tests, the organization demonstrates its commitment to quality, safety, and continuous improvement. This practice helps ensure that error-proofing measures remain effective in preventing or detecting errors, contributing to the organization’s compliance with IATF 16949 and its ability to deliver high-quality products and services in the automotive industry.

Challenge parts

In the context of quality management, particularly in the automotive industry and compliance with standards such as IATF 16949, the concept of “challenge parts” refers to specially designated components or items used for testing, validation, or calibration purposes. These challenge parts are used to assess the performance of processes, equipment, or systems and to verify that they are functioning within specified tolerances. Here’s how the organization can implement the requirement of identifying, controlling, verifying, and calibrating challenge parts:

Clearly identify challenge parts with unique labels, codes, or markings that distinguish them from regular production parts. This ensures that challenge parts are easily recognizable and not confused with actual production items.
Establish a controlled storage area or system for challenge parts to prevent mix-up or contamination. Implement measures to prevent unauthorized access and use of challenge parts.
Maintain detailed documentation specifying when and how challenge parts are used. This includes the purpose of each challenge part, the process or equipment being tested, and the expected outcomes.
Verify and calibrate challenge parts whenever feasible. This ensures that challenge parts themselves are accurate and reliable for testing purposes. Calibration may involve comparing challenge parts to reference standards or calibration equipment.
Periodically inspect challenge parts for signs of wear, damage, or deterioration. Replace challenge parts as needed to maintain their accuracy and effectiveness.
Use challenge parts to perform validation testing on equipment, processes, or systems. This helps confirm that the equipment is functioning as expected and producing accurate results.
Collect and analyze data from challenge part tests to assess the performance of processes or systems. Compare the results to established benchmarks or specifications.
If challenge part tests reveal discrepancies or deviations, implement necessary adjustments or corrective actions to bring processes or equipment back into compliance.
Maintain traceability records that demonstrate the use of challenge parts, testing results, and any actions taken based on the test outcomes. These records provide evidence of compliance and continuous improvement efforts.
Ensure that employees involved in using challenge parts are properly trained in their correct handling, usage, and documentation procedures.
Maintain open communication with relevant stakeholders, including quality assurance, production, and engineering teams, to ensure that challenge parts are appropriately used and contribute to process improvement.

By implementing these measures, the organization can effectively utilize challenge parts to validate processes, equipment, or systems, and ensure that production processes are consistently meeting quality standards and specifications. This approach supports compliance with IATF 16949 and helps enhance the organization’s overall quality management efforts in the automotive industry.

Reaction Plan

Developing a reaction plan for error-proofing device failures is a crucial aspect of maintaining the effectiveness and reliability of error-proofing measures in your organization. A reaction plan outlines the steps to be taken when an error-proofing device fails or malfunctions, ensuring that appropriate actions are promptly implemented to prevent defects or errors from reaching customers. Here’s how you can create a comprehensive reaction plan for error-proofing device failures:

Identification and Escalation: Clearly define the conditions or triggers that indicate an error-proofing device has failed or malfunctioned. Establish a process for operators or personnel to identify and escalate such issues.
Immediate Containment: When a failure is detected, initiate immediate containment actions to prevent defective products from progressing further in the process. This could involve stopping production, isolating affected parts, or taking other appropriate measures.
Isolation and Investigation: Isolate the area or equipment associated with the failed error-proofing device. Form a cross-functional team to investigate the root cause of the failure and identify contributing factors.
Root Cause Analysis: Use structured problem-solving methodologies (e.g., 5 Whys, Fishbone diagrams) to conduct a thorough root cause analysis. Determine why the error-proofing device failed and what led to the failure.
Immediate Corrective Actions: Develop and implement immediate corrective actions to address the root cause of the error-proofing device failure. These actions should aim to prevent the same issue from recurring.
Validation and Testing: Verify the effectiveness of the corrective actions by testing the error-proofing device under controlled conditions. Ensure that it functions as intended and reliably prevents or detects errors.
Communication:Maintain clear and timely communication with relevant stakeholders, including production teams, quality assurance, management, and, if necessary, customers. Inform them about the failure, actions taken, and expected outcomes.
Revised Standard Operating Procedures (SOPs): Update standard operating procedures (SOPs) or work instructions related to the error-proofing device to reflect the corrective actions and any changes made to prevent future failures.
Training and Awareness: Provide training to operators and personnel on the updated procedures and any changes to the error-proofing device. Ensure that they understand the importance of following the new protocols.
Long-Term Corrective Actions: Develop long-term corrective actions that address systemic issues to prevent similar failures across different error-proofing devices or processes.
Documentation and Records: Document all actions taken, investigation findings, corrective actions, testing results, and communication related to the error-proofing device failure. Maintain detailed records for future reference.
Continuous Improvement: Use insights gained from the failure and investigation to drive continuous improvement in error-proofing devices, processes, and quality management systems.
Review and Approval: Ensure that the reaction plan and its implementation are reviewed and approved by relevant stakeholders, including quality assurance and management.

By developing and implementing a comprehensive reaction plan for error-proofing device failures, the organization demonstrates its commitment to proactive quality management, defect prevention, and continuous improvement. This approach aligns with the principles of IATF 16949 and contributes to the organization’s ability to consistently deliver high-quality products and services in the automotive industry.

IATF 16949:2016 Clause 10.2.3 Problem solving

Problem-solving in the context of IATF 16949, the automotive quality management standard, involves structured approaches to identifying, analyzing, and resolving issues within an organization’s processes, products, or services. IATF 16949 places a strong emphasis on preventing defects, reducing variation, and continuously improving the quality of automotive products. Effective problem-solving is essential for achieving these objectives. Here’s how problem-solving is typically approached within the framework of IATF 16949. Clearly articulate the problem or issue that needs to be addressed. This might involve identifying defects, non-conformities, customer complaints, or other quality-related concerns. Collect relevant data and information related to the problem. This could include data on defects, process outputs, customer feedback, and any other relevant metrics. Use structured methodologies such as the “5 Whys,” Fishbone (Ishikawa) diagram, or Failure Mode and Effects Analysis (FMEA) to identify the underlying root causes of the problem. Develop and implement corrective actions to address the root causes. These actions are designed to eliminate or mitigate the identified causes of the problem. Ensure that the corrective actions are effective in resolving the problem. Verify that the identified causes have been eliminated or controlled and validate that the problem no longer persists. Consider implementing preventive actions to avoid recurrence of the problem in the future. These actions focus on identifying and addressing potential issues before they lead to problems. Document the entire problem-solving process, including the problem statement, data collected, root cause analysis, corrective and preventive actions taken, and the results of verification and validation. Integrate the lessons learned from problem-solving efforts into the organization’s continuous improvement initiatives. Use the information to drive improvements in processes, products, and systems. Involve cross-functional teams in problem-solving efforts. Different perspectives and expertise can contribute to a more comprehensive and effective resolution. Consider the impact of the problem on customers and prioritize solutions that align with customer expectations and requirements. Ensure that top management is informed about significant problem-solving efforts and their outcomes. This helps demonstrate the organization’s commitment to quality improvement. Ensure that employees involved in problem-solving are properly trained in relevant methodologies and techniques. Problem-solving within IATF 16949 is an ongoing and systematic process that aims to enhance product quality, customer satisfaction, and overall organizational performance. It is an integral part of the quality management system and contributes to the organization’s ability to meet automotive industry standards and regulatory requirements.

10.2.3 Problem solving

The organization must have a documented process(es) for problem solving. The process must define approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings). The process must include containment, interim actions, and related activities necessary for control of nonconforming outputs ;root cause analysis, methodology used, analysis, and results;implementation of systemic corrective actions, including consideration of the impact on similar processes and products; verification of the effectiveness of implemented corrective actions; reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan). Where the customer has specific prescribed processes, tools, or systems for problem solving, the organization shall use those processes, tools, or systems unless otherwise approved by the customer.

The organization must define process for identifying and using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity. Use the customer prescribed problem-solving format (e.g. 8D form), where available. Problem-solving tools may include – analysis of failure mode; capability studies; correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); FMEA review; histograms; Pareto analysis; probability charts; stratification of data; graphic representations; etc. Ensure that personnel applying these tools are competent and trained. Do a Pareto analysis of the root causes of all your corrective actions by type, process, product, etc to prioritize problem-solving resources and applying lessons learned. Also, consider doing a Pareto analysis of cost of poor quality data to prioritize corrective action. Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc or any combination of these. Conduct tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity, you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete. There are many tools you can use to help you determine the root cause of problems. These are known as disciplined problem solving methods. Disciplined methods are those proven methods that employ fundamental principles to reveal information. There are two different approaches to problem solving. The first is used when data is available, as is the case when dealing with nonconformities. The sec ond approach is when not all the data needed is available. The seven quality tools in common use are as follows:

Pareto diagrams – used to classify problems according to cause and phenomenon
Cause and effect diagrams – used to analyze the characteristics of a process or situation
Histograms – used to reveal the variation of characteristics or frequency distribution obtained from measurement
Control charts – used to detect abnormal trends around control limits
Scatter diagrams – used to illustrate the association between two pieces of corresponding data
Graphs – used to display data for comparative purposes
Check-sheets – used to tabulate results through routine checks of a situation

Click here on more on seven quality tools

The further seven quality tools for use when not all data is available are:

Relations diagram – used to clarify interrelations in a complex situation
Affinity diagram – used to pull ideas from a group of people and group them into natural relationships
Tree diagram – used to show the interrelations among goals and measures
Matrix diagram – used to clarify the relations between two different factors (eg. QFD)
Matrix data-analysis diagram — used when the matrix chart does not provide information in sufficient detail
Process decision program chart – used in operations research
Arrow diagram – used to show steps necessary to implement a plan (e.g. PERT)

Please click here for more on new seven QC tools

There are other techniques such as force field analysis and the simple “Why? Why?” technique which very quickly often reveals the root cause of a problem. The source of causes is not unlimited. Nonconformities are caused by one or more of the following:

Deficiencies in communication
Deficiencies in documentation
Deficiencies in personnel training and motivation
Deficiencies in materials
Deficiencies in tools and equipment
Deficiencies in the operating environment

Each of these is probably caused by deficiencies in management, its planning, organization, or control. Once you have identified the root cause of the nonconformity you can propose corrective action to prevent its recurrence. Eliminating the cause of nonconformity and preventing the recurrence of nonconformity are essentially the same thing. The key to successful diagnosis of causes is to keep asking the question: why? When you encounter a “don’t know” then continue the investigation to find an answer.

Establishing a comprehensive problem-solving process

Establishing a comprehensive problem-solving process that covers various types and scales of problems is crucial for maintaining effective quality management and continuous improvement within an organization, as required by IATF 16949. Such a process ensures consistency, efficiency, and thoroughness in addressing different challenges that may arise. Here’s how the organization can develop a problem-solving process that encompasses various problem types and scales:

Clearly define the types of problems that can occur within the organization, such as new product development issues, manufacturing challenges, field failures, and audit findings.
Categorize problems based on their nature and impact. Prioritize problems according to their significance, potential risks, and urgency.
Establish cross-functional problem-solving teams that include individuals with diverse skills and expertise relevant to the specific problem type.
Define problem-solving methodologies and techniques suitable for different problem types. For example, use advanced problem-solving techniques like Six Sigma, Lean, or DMAIC for complex manufacturing issues, and use root cause analysis techniques for field failures.
Provide teams with appropriate problem-solving tools, such as Fishbone diagrams (Ishikawa), 5 Whys, Pareto charts, Process Failure Mode and Effects Analysis (PFMEA), Failure Mode and Effects Analysis (FMEA), and statistical analysis tools.
Develop a specific approach for addressing issues related to new product development, including requirements validation, design reviews, prototyping, and testing.
Define steps to address current manufacturing challenges, such as deviations from standard operating procedures, variations in processes, and quality control failures.
Establish protocols to investigate and rectify field failures, including procedures for analyzing returned products, diagnosing root causes, and implementing corrective actions.
Outline procedures for addressing audit findings, including internal and external audit results. Develop a plan to close identified non-conformities and implement corrective actions.
Require detailed documentation of problem-solving efforts, including problem statements, root cause analyses, corrective actions, verification of effectiveness, and any preventive measures taken.
Incorporate problem-solving outcomes and progress into management review meetings to ensure visibility and alignment with organizational objectives.
Continuously review and improve the problem-solving process based on feedback, lessons learned, and the organization’s evolving needs.
Provide training to employees on the problem-solving process, methodologies, and tools to ensure that they are equipped to address various types of problems effectively.

By establishing a well-defined problem-solving process that encompasses different problem types and scales, the organization can enhance its ability to identify, analyze, and resolve challenges in a systematic and timely manner. This contributes to the organization’s overall quality management efforts, customer satisfaction, and compliance with IATF 16949 requirements.

The process must include containment, interim actions, and related activities necessary for control of nonconforming outputs ;root cause analysis, methodology used, analysis, and results;implementation of systemic corrective actions, including consideration of the impact on similar processes and products; verification of the effectiveness of implemented corrective actions; reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan). Here’s how you can develop and execute this process:

When a nonconforming output is identified, the first step is to implement containment actions to prevent further distribution or use of the nonconforming product. This could involve segregating affected products, suspending production, or other appropriate measures.
Implement interim actions to minimize the immediate impact of the nonconformity. These actions could include rework, sorting, or temporary workarounds.
Conduct a thorough root cause analysis to identify the underlying factors that led to the nonconformity. Use techniques such as the 5 Whys, Fishbone diagrams, or Failure Mode and Effects Analysis (FMEA) to systematically explore the causes.
Define the methodology that will be used for the root cause analysis. Clearly document the approach, data sources, and tools employed.
Analyze the collected data and evidence to identify the primary and contributing causes of the nonconformity.
Document the results of the root cause analysis, including the identified root causes and any causal relationships between factors.
Develop corrective actions that address the identified root causes. Ensure that these actions are systemic and will prevent the recurrence of similar issues in the future.
Assess the potential impact of the corrective actions on similar processes, products, or areas within the organization. Address any potential ripple effects and take preventive measures if needed.
Implement the identified corrective actions, which may involve process changes, procedure updates, training, or other relevant measures.
Verify the effectiveness of the implemented corrective actions by monitoring the relevant metrics, performing tests, or other appropriate methods.
Review and update documented information that may have been affected by the nonconformity and corrective actions. This could include Process Failure Mode and Effects Analysis (PFMEA), control plans, work instructions, and other relevant documents.
Use the lessons learned from the problem-solving process to drive continuous improvement in processes, products, and systems.
Ensure that the proposed corrective actions and their potential impacts are reviewed and approved by relevant stakeholders, including management and quality assurance personnel.
Keep stakeholders informed about the progress of problem-solving efforts, corrective actions, and their outcomes.
Maintain a comprehensive record of the problem-solving process, including containment, root cause analysis, corrective actions, and verification results.

By following this structured process, the organization can effectively address nonconforming outputs, prevent recurrence, and improve overall process performance. This approach aligns with the requirements of IATF 16949 and contributes to a culture of quality and continuous improvement.

Customer’s specific prescribed processes, tools, or systems for problem-solving

Adhering to your customer’s specific prescribed processes, tools, or systems for problem-solving is crucial to maintaining a strong customer-supplier relationship and ensuring that issues are resolved in a manner that aligns with your customer’s expectations. Thoroughly review and understand the problem-solving processes, tools, or systems prescribed by each customer. This may be outlined in contracts, quality agreements, or specific documentation provided by the customer. Confirm that the organization’s existing problem-solving processes align with the customer’s requirements. Identify any gaps or differences between the organization’s processes and the customer’s prescribed methods. If the organization’s existing processes do not align with the customer’s requirements, seek approval from the customer before deviating from their prescribed processes, tools, or systems. This may involve formal communication and documentation. Maintain open communication with the customer regarding problem-solving efforts. Inform the customer about the steps being taken to address the issue, the proposed corrective actions, and any potential deviations from their prescribed methods. If the organization believes that a deviation from the customer’s prescribed processes is necessary and can lead to a more effective resolution, formally request approval from the customer before proceeding. Collaborate with the customer throughout the problem-solving process, seeking their input and feedback. This ensures that the approach taken is aligned with their expectations and preferences. Document any deviations from the customer’s prescribed processes, tools, or systems, along with the rationale for the deviation and the approval received (if applicable).Use insights gained from problem-solving efforts to enhance the organization’s processes and align them more closely with customer requirements over time. Ensure that employees involved in problem-solving are trained in the customer’s prescribed methods and are competent to use the specified processes, tools, or systems. In case of any disputes or challenges in aligning with the customer’s requirements, escalate the matter through appropriate channels to seek resolution. By following these steps, the organization can ensure that problem-solving efforts are conducted in a manner that meets the customer’s expectations and requirements. This approach fosters a collaborative relationship, enhances customer satisfaction, and contributes to the organization’s commitment to delivering high-quality products and services.

IATF 16949:2016 Clause 9.2.2.2 Quality management system audit

Please read the article of ISO 9001:2015 internal audit before reading this article. The Quality Management System audit process is covered on that article.

An audit is a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audits are structured and formal evaluations. The term systematic means the company must plan and document its system for auditing. It must have management support and resources behind it. Audits must be performed in an impartial manner, which requires auditors to have freedom from bias or other influences that could affect their objectivity. For example, having responsibility for the work, or a vested interest or shares in a supplier or third party company they are assigned to audit would be conflicts of interest. Internal audits must be carried out to a process . The process must address the responsibilities for conducting the audits, ensuring independence, recording results, and reporting to management. Audits obtain objective evidence of conformity with requirements. The evidence must be based on fact and may be obtained through observation, measurement, test, or by other means. Evaluating the extent to which audit criteria are fulfilled involves an assessment of both implementation and effectiveness. The presence of nonconformities in a department or process may indicate the system is ineffective for those areas.Audit results are a major input to the management review process. Management must take appropriate actions based on the review of quality system strengths, weaknesses, and opportunities for improvement. The allocated time and for conducting internal audits demonstrates top management commitment. If the purpose of the audit is properly communicated, and employees realize that the audit is not an evaluation of personal performance, they are more likely to discuss weak areas and opportunities for improvement. This should lead to an improvement in operational performance and improved customer satisfaction. A quality management system audit in IATF 16949 involves a comprehensive evaluation of an organization’s QMS to ensure it meets the requirements of the standard and is effectively implemented to ensure consistent product quality, customer satisfaction, and continuous improvement. Here are the key aspects of a quality management system audit in IATF 16949:

Scope and Objectives: Define the scope and objectives of the audit, including the areas, processes, and functions that will be audited. This should cover all relevant aspects of the QMS, including design and development, production, service, and support processes.
Audit Planning: Develop an audit plan that outlines the audit schedule, audit team composition, audit criteria, and the methods and tools to be used during the audit.
Document Review: Examine the organization’s QMS documentation, including the quality manual, procedures, work instructions, records, and any other relevant documents. Verify that the documentation is complete, up-to-date, and aligned with the requirements of IATF 16949.
Process Auditing: Conduct process audits to evaluate how the organization’s processes are planned, implemented, and controlled. This includes assessing the effectiveness of process controls, risk management, and the use of appropriate performance indicators.
Compliance Assessment: Evaluate the organization’s compliance with the specific requirements of IATF 16949, which include customer-specific requirements, core tools (e.g., APQP, PPAP, FMEA), and other industry-specific standards.
Performance Measurement: Assess the organization’s performance measurement and monitoring mechanisms to ensure that the QMS is achieving its intended outcomes, meeting customer requirements, and driving continuous improvement.
Internal Audits: Review the organization’s internal audit program and records to determine if internal audits are being conducted effectively and are adding value to the QMS.
Management Review: Evaluate the effectiveness of the organization’s management review process in providing top management with insights into the performance of the QMS and making informed decisions.
Corrective Actions: Verify the organization’s process for identifying and addressing non-conformities, implementing corrective actions, and preventing recurrence.
Continual Improvement: Examine the organization’s efforts in pursuing continual improvement, including the use of data-driven decision-making and the promotion of a culture of excellence.
Reporting: Compile audit findings into a comprehensive audit report that includes strengths, weaknesses, opportunities for improvement, and non-conformities. Ensure that the report is objective, factual, and clearly communicates the audit results.
Follow-up and Verification: Monitor the implementation of corrective actions and verify their effectiveness in resolving identified issues.

A successful quality management system audit in IATF 16949 helps the organization identify areas for improvement, ensure compliance with industry standards, and achieve its quality objectives. It also demonstrates the organization’s commitment to delivering high-quality products and services to customers and stakeholders.

Clause 9.2.2.2 Quality management system audit

The organization shall audit all quality management system processes over each three-year calendar period, according to an annual program, using the process approach to verify compliance with this Automotive QMS Standard. Integrated with these audits, the organization shall sample customer-specific quality management system requirements for effective implementation.

Auditing all quality management system (QMS) processes over a three-year calendar period, according to an annual program, is a structured approach to ensuring the effectiveness, compliance, and continuous improvement of the organization’s QMS. This periodic audit cycle allows the organization to systematically review its processes, identify areas for improvement, and maintain alignment with quality standards and customer expectations. Here’s how the process can be implemented:

Audit Planning:
- Establish an annual audit program that outlines the processes to be audited each year over the three-year cycle.
- Identify the scope and objectives of each audit, specifying the QMS processes and areas to be covered.
Process Selection:
- Determine which QMS processes will be audited in each year of the three-year cycle.
- Consider factors such as process criticality, risk, customer impact, changes in the organization, and any recent audit findings.
Audit Execution:
- Conduct audits according to the schedule defined in the annual program.
- Assign competent auditors to each audit who are knowledgeable about the QMS processes being audited.
Compliance and Effectiveness:
- Assess each audited process for compliance with relevant standards, regulations, and documented procedures.
- Evaluate the effectiveness of each process in achieving its intended objectives and contributing to the organization’s quality goals.
Data Collection and Analysis:
- Collect data and evidence during the audits to support the assessment of process compliance and effectiveness.
- Analyze the collected data to identify trends, patterns, and areas that require improvement.
Corrective Actions and Improvement:
- Document any non-conformities or opportunities for improvement identified during the audits.
- Recommend and implement corrective actions to address non-conformities and enhance process performance.
Reporting:
- Prepare audit reports for each process audit, summarizing findings, non-conformities, corrective actions, and improvement recommendations.
- Communicate the audit results to relevant stakeholders, including process owners and management.
Follow-up and Verification:
- Monitor the implementation of corrective actions to ensure their effectiveness in resolving identified issues.
- Conduct follow-up audits or verification activities as needed to confirm the successful closure of non-conformities.
Continuous Improvement:
- Use the insights gained from the process audits to drive continuous improvement efforts within the organization.
- Update processes, procedures, and practices based on lessons learned and best practices identified during audits.

By conducting regular audits of all QMS processes over the three-year calendar period, the organization can ensure the ongoing effectiveness of its quality management system, identify areas for enhancement, and demonstrate its commitment to maintaining high standards of quality, compliance, and customer satisfaction.

Customer-specific quality management system (QMS) requirements

Integrating customer-specific quality management system (QMS) requirements into the audit process is a proactive approach to ensuring that the organization effectively implements these requirements and meets the expectations of its customers. By sampling and assessing customer-specific QMS requirements alongside regular QMS audits, the organization can demonstrate its commitment to customer satisfaction and align its processes with specific customer needs. Here’s how this integration can be achieved:

Thoroughly review and understand the specific quality management system requirements outlined by each customer. These requirements may include contractual agreements, quality standards, industry-specific guidelines, and any additional expectations communicated by the customer.
Integrate customer-specific QMS requirements into the organization’s audit plan. Identify which customer requirements need to be audited and determine the appropriate timing and frequency for these audits.
Clearly define the scope of each audit to include both general QMS processes and the specific customer requirements that apply to those processes.
Develop a sampling approach for auditing customer-specific QMS requirements. This could involve selecting relevant processes, products, or projects that are directly impacted by the customer requirements.
Conduct audits according to the integrated plan. Auditors should assess the effective implementation of both general QMS processes and the customer-specific requirements associated with those processes.
Collect documentation and evidence that demonstrate compliance with customer-specific requirements. This may include records, reports, communication logs, and any other relevant artifacts.
Verify that the organization’s processes align with customer-specific requirements and that the appropriate controls and actions are in place to meet those requirements.
Include the assessment of customer-specific QMS requirements in the audit reports. Clearly communicate the organization’s conformance to these requirements and any areas that require improvement.
Use audit findings related to customer-specific requirements to identify opportunities for improvement. Address any gaps or non-conformities through corrective and preventive actions.
Maintain open communication with customers regarding the audit process and the organization’s commitment to implementing their specific requirements effectively.
Incorporate feedback from customer interactions and audits into the organization’s quality improvement initiatives. This can help refine processes and enhance customer satisfaction over time.

By integrating customer-specific QMS requirements into the audit process, the organization demonstrates its dedication to meeting customer expectations and delivering products and services that align with customer needs. This approach contributes to building strong customer relationships, enhancing customer loyalty, and positioning the organization as a reliable and customer-focused partner in quality.

IATF 16949:2016 Clause 9.2.2.4 Product audit

Product audit is defined as an examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards and customer requirements). A product audit is a systematic examination and evaluation of a company’s finished products to ensure they meet specified quality standards, customer requirements, and regulatory compliance. The primary purpose of a product audit is to assess the conformance of the actual product to its intended design and performance specifications. Product audits take place after manufacturing is complete, but before the product reaches the customer. If a product doesn’t meet standard requirements or specifications, the auditor documents the findings and logs a non-conformance.While each company will have its own procedures for addressing non-conformances, the process typically includes:

Identifying the problem
Containing the non-conformance
Reworking or repairing the products, if possible
Disposing of nonconforming products if you can’t rework or repair them
Determining the necessary countermeasures for preventing recurrence

Product audits can help a manufacturer improve quality, profits, customer satisfaction, and loyalty. There is one catch: you must do them consistently and effectively, taking steps to identify process errors that are the root cause of defects. If you don’t, you’ll still see high internal failure rates and an increased likelihood of defects going undetected until they reach the customer. The of the most important aspects of the product audit process is that it doesn’t just involve the product management team. While they are certainly key contributors, it is truly a 360-degree review of product strategy and product development. That means that representatives from the sales team to quality assurance to customer support should be participating, because the items being audited impact all of these departments.Like all projects, the audit should begin with a kick-off meeting, including the auditor(s), executive sponsors and stakeholders. This meeting should clearly communicate the purpose of the audit and that full participation is expected from all relevant departments. It should also set the tone that while this audit will undoubtedly uncover and identify shortcomings in the current product management process, this is an opportunity for improvement and not assigning blame or fault.The next phase is a documentation review, where the auditor should be given access to all relevant documents and tools used in the product management process (both templates and actual work product). This is the forensic stage of the audit where the auditor can cross-reference what exists vs. what should be in place.The third step is interviewing staff. These interviews will mostly be conducted one-on-one between the auditor and each relevant staff member, which will encourage participants to be as honest and open as possible as well as allowing the interview to get in-depth on the related topics. A key to the interview process—which can be augmented with written or online surveys—is asking all participants the same questions to rate the effectiveness and quality of different parts of the process. These individual responses will be critical to the final ratings and can drive prioritization for areas of improvement. Next, the auditor will aggregate the results of the reviews and interviews to compile their findings. The final report can be delivered as a presentation and/or as a written document, but both formats will contain the same information. The goal of the report is to score every single element of the current product management situation so gaps can be identified and weaknesses addressed. The official process can conclude with a workshop where the results are reviewed in a group setting with all relevant stakeholders. Based on the called out deficiencies in the current process, action plans can be developed and tasks assigned to improve things. The final item on the agenda should be determining when the next audit should be conducted so progress can be measured and new opportunities for improvement can be identified.

Key aspects of a product audit may include:

Inspection and Testing: The auditor inspects and tests randomly selected samples of finished products to verify that they meet the defined criteria, specifications, and quality standards.
Conformance to Specifications: The product is assessed against predetermined criteria, such as dimensions, tolerances, materials, functionality, and performance, to confirm whether it aligns with the intended design and requirements.
Customer Requirements: The product is evaluated to ensure that it meets the specific requirements and expectations of the customers.
Regulatory Compliance: The product audit verifies whether the finished product complies with relevant industry regulations, safety standards, and legal requirements.
Product Packaging and Labeling: The auditor examines the product’s packaging and labeling to ensure they are accurate and appropriate for the product’s intended use.
Traceability and Documentation: The auditor checks the product’s traceability back to the production process and confirms that all necessary documentation, such as production records and quality control reports, is complete and accurate.
Non-Conformance Identification: If any deviations or non-conformities are found during the product audit, they are documented, and appropriate corrective actions are recommended.
Sampling Techniques: Depending on the size of the production batch, the auditor may use various statistical sampling techniques to select representative samples for evaluation.
Continuous Improvement: Product audits provide valuable feedback to the organization, enabling them to identify areas for improvement in their production processes and enhance product quality over time.

Product audits are essential in ensuring that products meet the required quality standards and conform to customer expectations. By conducting these audits, companies can detect potential product defects or issues early on, prevent non-compliant products from reaching customers, and uphold their reputation for producing high-quality goods. Additionally, product audits contribute to maintaining compliance with industry regulations and building trust with customers, leading to increased customer satisfaction and loyalty.

Clause 9.2.2.4 Product audit

The organization is to audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization must define the approach to be used

Auditing products at appropriate stages of production and delivery to verify conformity to specified requirements is an essential quality management practice that ensures products meet the established standards and customer expectations. By conducting these audits at critical points throughout the production process and during delivery, the organization can identify and address any non-conformities early on, preventing defective or non-compliant products from reaching customers. Here’s how the organization can implement this process effectively:

Identify Critical Stages: Determine the key stages in the production process and delivery where product quality and conformity are critical. These stages may include raw material inspection, intermediate checkpoints during manufacturing, final product inspection, packaging, and shipping.
Define Audit Criteria: Establish specific criteria and requirements that products must meet at each identified stage. These criteria should align with the specified requirements, customer expectations, and any relevant industry standards or regulations.
Develop Audit Plans: Create detailed audit plans for each stage, outlining the scope, objectives, methods, and resources for conducting the audits. The plans should also specify the frequency of audits at each stage.
Inspection and Testing: Conduct inspections and tests at each stage to verify product conformity. This may involve visual inspection, dimensional checks, performance testing, or any other relevant assessment methods.
Document Review: Review documentation and records related to each product, such as material certifications, process control data, inspection reports, and quality records, to ensure that the products meet specified requirements.
Sample Selection: Use appropriate sampling techniques to select representative samples for evaluation at each stage. The sample size and method should be statistically sound and based on the level of confidence required.
Root Cause Analysis: If any non-conformities are identified during the audits, perform a root cause analysis to understand the underlying reasons for the issues. Address these root causes to prevent recurrence.
Corrective Actions: Implement timely corrective actions to address identified non-conformities and ensure that products are brought into compliance before proceeding to the next production stage or shipment.
Continuous Improvement: Use the audit findings to identify opportunities for process improvement and enhance product quality over time. Continuously update audit criteria and methods based on feedback and lessons learned.
Reporting: Document the audit results in comprehensive reports, including findings, non-conformities, corrective actions, and opportunities for improvement. Share the reports with relevant stakeholders and management.

By conducting product audits at appropriate stages of production and delivery, the organization can maintain consistent product quality, prevent defects, and ensure customer satisfaction. This systematic approach to quality control helps the organization deliver products that meet or exceed customer expectations and comply with all specified requirements. Additionally, it contributes to building trust with customers and stakeholders by demonstrating a commitment to producing reliable and conforming products.

Customer specific approaches

When an organization is required to audit products using customer-specific approaches, it means that each customer may have their own unique set of requirements and expectations for how product audits should be conducted. These requirements could include specific audit criteria, evaluation methods, sampling techniques, documentation, and reporting formats. The organization must adhere to these customer-specific approaches during the product audit process. Here’s how they can execute these audits effectively:

Understand Customer Requirements: Thoroughly review the requirements and expectations of each customer regarding product audits. This may involve studying contracts, quality agreements, specifications, and any other relevant documents provided by the customers.
Develop Customer-Specific Audit Plans: Based on the customer’s requirements and any industry standards or best practices, the organization should create tailored audit plans for each product audit. These plans should outline the scope, objectives, audit criteria, methods, and resources to be used in the audits.
Training and Competency: Ensure that the auditors who will conduct the product audits are well-trained and competent in using the customer-specific approach. They should be familiar with the audit criteria and methodologies required by each customer.
Compliance with Customer Standards: During the product audit, strictly adhere to the customer’s prescribed audit standards and procedures. The auditors should apply the specified evaluation methods, use the appropriate sampling techniques, and collect the required data accordingly.
Document Review: Thoroughly review all customer-specific requirements and documentation related to the product being audited. This may include checking product specifications, quality control records, and any other relevant documents provided by the customer.
Report Generation: After each product audit is completed, generate a comprehensive report that aligns with the customer’s reporting format and includes all the relevant findings, non-conformities, and recommendations for corrective actions.
Communication with Customers: Maintain open and transparent communication with customers throughout the audit process. Share the audit results, address any customer concerns, and collaborate on implementing corrective actions when necessary.
Continuous Improvement: Use the product audit findings to drive continuous improvement efforts in the production process. Implement corrective actions promptly and monitor their effectiveness over time.
Follow-Up Audits: In some cases, follow-up audits may be required to verify that corrective actions have been effectively implemented and to ensure sustained improvements.

By conducting product audits using customer-specific approaches, the organization can demonstrate its commitment to meeting customer expectations and delivering products that consistently meet the required quality standards. This approach also helps build strong relationships with customers and enhances the organization’s reputation as a reliable and quality-driven supplier.

Organization’s approach

when specific product audit approaches are not defined by the customer, it becomes the responsibility of the organization to establish and define the appropriate approach to be used during the product audit process. This involves creating audit plans and methodologies that align with the organization’s own quality standards, industry best practices, and regulatory requirements.Here are the steps the organization can follow to define the product audit approach:

Internal Standards and Procedures: The organization should review its internal quality management system and existing audit procedures. These standards should be based on recognized quality frameworks such as ISO 9001 or industry-specific standards, if applicable.
Best Practices: Research industry best practices for product audits. Look into guidelines and recommendations provided by industry associations, regulatory bodies, and quality management experts.
Risk-Based Approach: Consider adopting a risk-based approach to product audits. Identify critical products, processes, or areas with higher risks or impact on customers and focus auditing efforts accordingly.
Sample Selection: Determine the appropriate sampling techniques to be used during the product audit. Random sampling, stratified sampling, or other statistical methods may be employed based on the organization’s objectives and the characteristics of the products being audited.
Audit Criteria: Establish specific audit criteria that address product specifications, quality standards, customer requirements, and relevant regulatory compliance.
Audit Checklist: Develop an audit checklist that outlines the key areas to be examined during the audit. This may include product specifications, materials, manufacturing processes, inspection procedures, and documentation.
Audit Team: Assemble a qualified and competent audit team with knowledge and expertise relevant to the products being audited.
Document Review: Ensure that all relevant documentation, including product specifications, quality records, inspection reports, and related documentation, are reviewed during the audit.
Audit Scope: Define the scope of the product audit, including the extent of coverage and the frequency of audits for different products or product categories.
Reporting: Establish a standardized reporting format for the product audit results. The report should include findings, non-conformities, root causes, corrective actions, and opportunities for improvement.
Continuous Improvement: Use the audit findings to identify areas for improvement in the production process and to drive continuous improvement efforts across the organization.

By defining their own approach to product audits when customer-specific requirements are not provided, the organization can ensure that their product audit process is consistent, effective, and aligned with their own quality objectives and industry best practices. This proactive approach also enables the organization to maintain control over product quality and demonstrate their commitment to delivering high-quality products to their customers.

IATF 16949:2016 Clause 9.2.2.3 Manufacturing process audit

Manufacturing process audits are a type of quality assurance that is performed to ensure that manufacturing processes conform to the company’s quality standards. A manufacturing process audit is a systematic examination and evaluation of a company’s manufacturing processes to ensure they adhere to established standards, procedures, and best practices. The primary goal of a process audit is to identify any potential deviations, inefficiencies, or non-compliance issues in the production process. In addition, these audits aim to identify non-conformances and correct them before they cause problems downstream. Process audits can assess any type of manufacturing process, from simple assembly line processes to complex multi-step processes. This type of audit usually focuses on one specific process at a time but can also assess the entire manufacturing operation. Process audits come in various forms, from completing simple checklists to deeper and broader processes into specific manufacturing operations. During a process audit, the auditor records, aggregates, and categorizes potential non-conformances. Afterward, the operations staff will then perform corrective actions based on the audit findings. Process audits are a critical part of ensuring that lines are working properly and enforcing quality and safety. It also helps pinpoint non-conformances at the source. They help ensure that products are manufactured according to its quality standards. These audits can also help identify potential problems with the manufacturing process to be corrected before they cause defects in the finished product. They help to ensure that manufacturing processes are running smoothly and efficiently. By identifying bottlenecks and inefficiencies in the manufacturing process, process audits can help improve overall productivity. They can help to ensure compliance with regulatory requirements. By auditing the manufacturing process, companies can identify areas where they may be out of compliance and take corrective actions to fix the issue. Process audits offer several benefits to manufacturing companies. By conducting these audits, companies can assess the effectiveness and efficiency of their manufacturing processes, identify areas for improvement, and ensure the consistent production of high-quality products.Key aspects of a manufacturing process audit may include:

Documentation review: The auditor examines process documentation, including standard operating procedures (SOPs), work instructions, process flowcharts, and other relevant documents to ensure they are accurate, up-to-date, and being followed.
Observation: The auditor directly observes the manufacturing process in action, looking for deviations from established procedures, potential bottlenecks, and areas where improvements can be made.
Data analysis: The auditor may analyze production data, quality control records, and other performance metrics to identify trends, patterns, and possible issues affecting the manufacturing process.
Compliance check: The auditor verifies whether the manufacturing process complies with relevant industry standards, safety regulations, and any applicable legal requirements.
Root cause analysis: If any issues or non-conformities are identified during the audit, the auditor may conduct a root cause analysis to determine the underlying reasons for the problems and recommend corrective actions.
Continuous improvement: A key objective of the audit is to identify opportunities for process improvement. The auditor may suggest changes or enhancements to the manufacturing process to increase efficiency, reduce waste, and enhance product quality.

Manufacturing process audits can be conducted by internal auditors from the same organization or by external auditors who are independent of the manufacturing process being assessed. These audits play a vital role in maintaining product quality, ensuring consistency, and enhancing overall manufacturing performance. They also contribute to building trust with customers and stakeholders by demonstrating a commitment to delivering high-quality products.Some of the most important benefits are the following:

Helps ensure that products are manufactured according to company quality standards
Helps identify potential problems with the manufacturing process so they can have corrective action before they cause defects in the finished product
It Helps ensure that manufacturing processes are running smoothly and efficiently
Helps ensure compliance with regulatory requirements
Helps improve overall productivity

9.2.2.3 Manufacturing process audit

The organization has to audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specific required approaches for process audits. Where not defined by the customer, the organization must determine the approach to be used. Within each individual audit plan, each manufacturing process has to be audited on all shifts where it occurs, including the appropriate sampling of the shift handover. The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents.

The organization has to audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency. Conducting manufacturing process audits over a three-year calendar period helps to assess the effectiveness and efficiency of their production processes. This periodic audit approach allows the organization to gather sufficient data and make meaningful evaluations without being too burdensome on resources. .At the beginning of the three-year period, the organization should establish an audit plan. This plan outlines the schedule, scope, and objectives of the audits to be conducted during the period. It may identify the manufacturing processes that will be audited, the frequency of audits, and the resources required. The organization will decide which manufacturing processes will be audited based on their significance, risk level, impact on product quality, customer requirements, and any other relevant criteria. During the three-year period, individual audits are conducted based on the schedule outlined in the audit plan. The audits are typically carried out by internal or external auditors who have expertise in process evaluation and compliance. The auditors will gather relevant data during the audit process. This may include reviewing documentation, observing the manufacturing processes, interviewing personnel, and analyzing performance metrics. The auditors will assess the effectiveness and efficiency of the manufacturing processes based on predetermined criteria, such as adherence to standards, compliance with procedures, productivity levels, and quality output. Reporting: After each audit is completed, a comprehensive report is generated. The report includes findings, areas for improvement, non-conformities, and recommendations for corrective actions. Based on the audit findings, the organization will implement corrective actions to address identified issues and improve the manufacturing processes. Throughout the three-year period, the organization will continuously monitor the effectiveness of implemented corrective actions and make adjustments as needed. This process fosters a culture of continuous improvement within the organization. In some cases, follow-up audits may be conducted to verify that corrective actions have been effectively implemented and to ensure sustained improvements. By auditing all manufacturing processes over a three-year period, the organization can gain valuable insights into its overall manufacturing performance and identify trends or patterns that might not be apparent through more frequent but narrowly focused audits. It also allows them to allocate resources effectively and proactively address potential issues, resulting in enhanced product quality, increased efficiency, and improved customer satisfaction.

Customer-specific required approaches

When an organization is required to audit all its manufacturing processes using customer-specific approaches for process audits, it means that each customer may have their own unique set of requirements and expectations for how the audits should be conducted. These requirements could include specific audit criteria, evaluation methods, documentation, and reporting formats. Additionally, some customers might not provide explicit guidelines for the audit process, leaving the organization to decide on the appropriate approach.In such cases, the organization must follow these steps to ensure successful process audits. The first step is to thoroughly understand the specific requirements and expectations of each customer regarding process audits. This may involve reviewing contracts, quality agreements, specifications, and any other relevant documents provided by the customers. Based on the customer’s requirements and any industry standards or best practices, the organization should create tailored audit plans for each manufacturing process. These plans should outline the scope, objectives, audit criteria, methods, and resources to be used in the audits. Ensure that the internal or external auditors who will conduct the audits are well-trained and competent in using the customer-specific approach. They should be familiar with the audit criteria and methodologies required by each customer. During the audit, the organization must strictly adhere to the customer’s prescribed audit standards and procedures. The auditors should apply the specified evaluation methods and collect the required data accordingly. For customers who do not provide explicit audit requirements, the organization must be flexible and adaptable in determining the approach to be used. It may involve aligning with recognized industry standards or adopting best practices to ensure thorough and effective audits. After each audit, the organization should create comprehensive audit reports that align with the customer’s reporting format and include all the relevant findings, non-conformities, and corrective action recommendations. Open and transparent communication with customers is crucial throughout the audit process. The organization should share the audit results, address any customer concerns, and collaborate on implementing corrective actions when necessary. The organization should use the audit findings to drive continuous improvement efforts in their manufacturing processes. By addressing issues and making necessary enhancements, they can meet or exceed customer expectations. In summary, when faced with customer-specific approaches for process audits, the organization must carefully understand and comply with the unique requirements of each customer. By developing effective audit plans, using competent auditors, and maintaining open communication, the organization can demonstrate its commitment to quality and customer satisfaction.

Shift considerations

Auditing each manufacturing process on all shifts, including the appropriate sampling of shift handovers, is a comprehensive approach to ensure a thorough assessment of the process’s performance and consistency across different work shifts. Here’s how the organization can execute this process: For each manufacturing process, create a detailed audit plan that outlines the scope, objectives, and specific audit criteria to be evaluated during the audit. Determine the frequency of audits, ensuring that each shift is covered within the designated audit period. Identify all the shifts during which the manufacturing process occurs. This may include day shifts, night shifts, and any other shift patterns applicable to the organization’s production schedule. Determine the appropriate sampling size for each shift. The sample should be representative of the production activities and should provide sufficient data to assess the process’s effectiveness and compliance with standards. Pay special attention to shift handovers, where one shift’s team hands over responsibilities to the incoming shift. These handovers are critical points where communication and information transfer are crucial for maintaining process continuity and quality. During each shift, auditors should collect relevant data and observe the manufacturing process in action. This may include checking process parameters, equipment settings, quality control measures, and other critical factors. Engage with employees working on each shift to gain insights into their specific experiences and challenges during the production process. Effective communication with shift workers can provide valuable information about potential issues or opportunities for improvement. Assess whether the manufacturing process is being executed consistently across all shifts. Look for variations or deviations that may occur during different shifts and determine if there are any patterns or trends affecting process performance. Examine the shift handover procedures to ensure that critical information, including any ongoing process issues, quality concerns, and special instructions, are effectively communicated between shifts. After completing the audit for each shift, compile the findings into comprehensive reports. Compare the results between shifts and analyze any differences or trends observed. If any non-conformities or opportunities for improvement are identified during the audits, work with the relevant teams to implement corrective actions promptly. Use the audit findings and corrective actions to drive continuous improvement efforts across all shifts and manufacturing processes. By auditing each manufacturing process on all shifts, including sampling shift handovers, the organization can ensure that process effectiveness and efficiency are consistently monitored and improved. This approach also fosters a culture of accountability, encourages process standardization, and helps maintain a high level of product quality across all shifts.

Effective Implementation

Conducting an audit of the effective implementation of the process risk analysis, control plan, and associated documents is a critical aspect of ensuring the reliability, safety, and quality of the manufacturing processes. Here’s how the organization can carry out this audit:

Audit Scope and Objectives: Define the scope and objectives of the audit, focusing on the examination of the process risk analysis (e.g., Process Failure Mode and Effects Analysis – PFMEA), control plan, and other related documents.
Document Review: Gather and review all relevant documents, including the PFMEA, control plan, process flowcharts, work instructions, and any other documentation associated with the manufacturing process. Ensure these documents are up-to-date, accurate, and properly linked.
Risk Analysis Assessment: Evaluate the effectiveness of the process risk analysis (PFMEA) by examining how well potential failure modes, their effects, and mitigation measures are identified and documented. Verify whether risk rankings are appropriately assigned and whether the documented actions are relevant and actionable.
Control Plan Evaluation: Assess the control plan to determine if it adequately addresses the identified risks and ensures that appropriate control measures are in place to prevent or detect potential failures. Verify that the control plan aligns with the risk analysis and that it is followed consistently in the manufacturing process.
Compliance Check: Verify whether the documented risk analysis and control plan comply with the organization’s internal standards, industry best practices, and any customer-specific requirements.
Effectiveness Verification: Review records and data related to the process to assess the effectiveness of the implemented control measures in mitigating identified risks and preventing process deviations or defects.
Associated Documents Audit: Ensure that all associated documents, such as standard operating procedures (SOPs), work instructions, training materials, and change management records, are consistent with the risk analysis and control plan.
Process Operator Interviews: Interview the process operators and personnel involved in executing the manufacturing process to understand their awareness of risk analysis and control measures. Verify if they follow the prescribed procedures and if they have adequate training to handle potential risks effectively.
Gap Identification: Identify any gaps or deviations between the documented risk analysis, control plan, and their actual implementation in the manufacturing process.
Reporting and Corrective Actions: Compile the audit findings into a comprehensive report. Include any non-compliances, deviations, and improvement opportunities. Recommend corrective actions to address identified issues and enhance the effectiveness of the risk analysis and control plan implementation.
Continuous Improvement: Use the audit results to drive continuous improvement efforts in the manufacturing processes. Implement corrective actions promptly and monitor their effectiveness over time.

By conducting audits that focus on the effective implementation of the process risk analysis, control plan, and associated documents, the organization can strengthen its risk management practices, improve product quality, and enhance overall process performance. These audits also contribute to maintaining compliance with quality standards and regulatory requirements.