The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Advanced Product Quality Planning (APQP) in IATF. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.
1.0 Process Approach for Advanced Product Quality Planning (APQP)



2.0 Turtle Diagram for Advanced Product Quality Planning (APQP)

3.0 AQP Timing Plan Macro Level

Project Name : Project No : Project Leader : | |||||
Description | Planned | Actual | Remarks | ||
1 | CFT Sign Off | Team Leader & CFT | |||
2 | Availibility of Ref sample /3d model | ||||
3 | Feasibility review | Team Leader & CFT | |||
4 | Drawings finalize on TAL Format | Team Leader & Engg. HOD | |||
5 | Lsit of Discrepenceies observed in drgs. | Team Leader & Engg. HOD | |||
6 | Share Observations with Customer & Ask for Clarifications | 5- samples along with Insp. Report to be submit to customer 25th Dec.2015 | |||
Submiited for Clearance | Process owner | ||||
Signed for clearance of Gate -1 | Engg HOD | ||||
Signed for clearance of Gate -1 | DGM- | ||||
1 | BOM /List of Raw material – In – ERP | ||||
2 | Verification of Material TC from NABL Approved Lab | Quality | |||
3 | Fit & Finish Requirements & Agreement on Specimen / level with customer | Team Leader / Engg. Head & Customer | 5- samples to be submit to customer 25th Dec.2015 | ||
4 | Completion of Preliminary PFD /FMEA/CP | Team Leader & CFT | |||
5 | List OF Tools , Gauges & Jig fixtures | Team Leader & CFT | |||
6 | Closer of all Clarifications & Sign off | Customer SQA / Team Leader | Will be close after getting feed back of Customer | ||
7 | Tools, Fixture & Jig Designing (Tooling concepts to be Review & finalize in CFT ) | Team leader /CFT | |||
8 | Gauges Designing (Concepts to be Review & finalize in CFT) (Final check fixture & in process gauges) | Team leader /CFT | |||
9 | Validation of Tools, Jig & Fixture Design ( w.r.t. FMEA ) | Engg HOD / CFT | |||
10 | Validation of Gauge Designs (Final check fixture & in process gauges) | Engg HOD / CFT | |||
Submiited for Clearance | Process owner | ||||
Signed for clearance of Gate -2 | Engg HOD | ||||
Signed for clearance of Gate -2 | DGM- | ||||
1 | Tools, Jig & Fixture Manufacturing | Tool Room | |||
2 | Tools, Jig & Fixture Inspection ( Assy. & Stage inspection) | Tool Room | |||
3 | Tools, Jig & Fixture Issue to Production | Tool Room / Process Owner | |||
4 | Gauges Manufacturing | Tool Room | |||
5 | Gauges Inspection -Tool room ( Assy. & Stage inspection) | Tool Room | |||
6 | Gauges Calibration -Standard Room | Quality | |||
7 | Floor plan Layout approved by Directors | Team leader | |||
8 | New / Existing Machines/Equipment Requirement | Team leader /CFT | |||
9 | Tool Trial report with 10 no’s of samples | Tool Room | |||
10 | 10 no’s child parts hand over to Std Room for layout with inspection report | Process Owner / Quality | |||
11 | Approved Samples along with Signed ISIR Document -Send to Customer | Quality /Team Leader | |||
12 | Fitment Trials at Customer End | ||||
4.0 TEAM FEASIBILITY COMMITMENT
Date:
Part Name: Part Number :
Customer : Vehicle / Model:
Feasibility Consideration:
CFT has considered the following questions, not intended to be all-inclusive in performing a feasibility evaluation. The drawings and / or specifications provided have been used as a basis for analyzing the ability to meet all specified requirements. All “NO” answers are supported with attached comments identifying comments and / or proposed changes to enable us to meet the specified requirements.
YES | NO | CONSIDERAION |
Is product adequately defined (application requirements etc.) to enable feasibility review? | ||
Can Engineering Specification be met as written? | ||
Can product be manufactured to tolerances specified on drawing? | ||
Can Product be manufactured with Cpks’ that meet requirements? | ||
Is there adequate capacity to make the product? | ||
Does the design allow the use of efficient materials handling techniques? | ||
Can the product be manufactured without incurring any unusual : | ||
Cost for Capital Equipment? | ||
Cost for Tooling? | ||
Alternative Manufacturing Methods? | ||
Is Statistical Process Control required on product? | ||
Is Statistical Process Control presently used on similar products? | ||
Where Statistical Process Control is used on similar products : | ||
Are the processes in control and stable? | ||
Are Cpk’s greater than 1.33? |
CONCLUSION :
Feasible | Product can be produced as specified with no revisions | |
Feasible | Changes Recommended (See Attached Comments) | |
Not Feasible | Design Revision required to produce product with in specified requirements |
Comments: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _
SIGN-OFF
Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date
Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date
SUPPLIER SIGN-OFF
Supplier Name/Date Supplier Name/Date Supplier Name/Date
5.0 APQP Cross Functional Team
Date:
Product: Part No.:
Customer:
Scope of Team:
Team Leader: Position:
Team Members:
Sr. No. | Name | Deptt. | Designation | Major Responsibility | Signature |
01 | |||||
02 | |||||
03 | |||||
04 | |||||
05 | |||||
06 | |||||
07 | |||||
08 | |||||
09 | |||||
Meeting Frequency:
Team Leader: Date:
6.0 Customer Specific Requirements
S. No. | Name of Customer | Part # | PPAP Level | APQP Timing Plan | Special Characteristics of Products | Delivery Instructions | Pre Dispatch Inspection Report | Packaging standard | Record Retention Period | MSA Plan | SPC (Cpk) | Callibration Lab Approval | Customer Approved Supplier (If any) | Inspection Standards (If any) | Ref. Standard | Proto type Samples size | Line Rejection at Customer end from other supplier | Remarks |
7.0 Listing of Special Characteristics
LISTING OF SPECIAL CHARACTERISTICS
Part Name: Part Number:
Customer:
Preliminary | |
Final |
Sr. No. | Description of Special Characteristics | Specification & Tolerances | Reason for Spl Characteristics | Control Mechanism | Remarks | |
Process | Product | (Refer Notes below) | ||||
Note: Reason for Special Characteristics are Given below:
F/F =Fit / Function;
R =Regulatory Requirement
E=Environmental
S=Safety Requirements;
CP=Customer Prescribed
These special characteristics must be taken care while formulating PFMEA & Control Plans.
(Signature)
8.0 Identification of New Machine
IDENTIFICATION OF NEW MACHINES/ EQUIPMENTS | ||||
1. Identify significant characteristics (a) Product b)Process (Machining / Heat treatment /Welding / Surface protection) c) EEC parameters etc. | ||||
S.No. | Characteristics | Operation (Stage) | Control Mechanism | |
2. Fit & Finish Requirements & Agreement on Specimen /Level | ||||
Aesthetics: Agreement on Surface finish, Appearance ,Abnormalities and Assy related like Gap,Mismatch,Eveness and eccentric etc | ||||
Reference Sample Sign Off | ||||
Revalidation Frequency | ||||
3. Tooling – Cutting tools & jigs and fixtures | ||||
S.No. | Tooling Requirement | Make | Quantity | Completion date |
4. New / Existing Machines / Equipment requirement | ||||
S.No. | Machine / Equipment | Make / Type | Availability Status | |
5. Material Handling Equipment Requirement | ||||
S.No. | Equipment | Make | Quantity | Completion date |
6. Supplier selection for Bought-out Parts | ||||
S.No. | Parts | Supplier Name | TVS to approve (Yes / NO) | |
7. Sub-contracting requirements | ||||
S.No. | Operation Name | Supplier Name | TVS to approve (Yes / NO) | |
8.Gauges/Instruments / Test Equipment requirements | ||||
S.No. | Gauges / Instruments / Test Equipment Description | Make | Quantity | Completion date |
9. Identification & Traceability | ||||
Method | Stamp | |||
Supplier identification | TAL & IR No. | |||
Location | Hing, Rear Brake | |||
Traceability | TAL & IR No. | |||
10.Packing Method agreement-Explain the method briefly | ||||
Part preparation (Cleaning and oil application etc.): | ||||
Method of Primary packing: | ||||
Method of Secondary packing:. | ||||
Type of strapping: |
9.0 PROCESS FAILURE MODE AND EFFECT ANALYSIS (PROCESS FMEA)
Item : | Process Responsibility : | FMEA Number : | ||||||||||||||||
Core Team : | Key Date : | Prepared By : | ||||||||||||||||
Part No./Latest Change Level: | FMEA Date(ORG) : | Rev : | ||||||||||||||||
ModelYear (S)/Program(S) | Customer:- | |||||||||||||||||
OPN No. | Process Function/ Requirement | Potential Failure Mode | Potential Effect(s) of Failure | Sev. | Class | Potential Cause(s) Mechanism(s) of Failure | Current Process Controls | RPN | Recommended Action(s) | Resp. & Target, Completion Date | Action Results | |||||||
Controls Prevention | Occ. | Controls Detection | Det. | Actions Taken Completion Date | Sev | Occ | Det | RPN | ||||||||||
Prepared By: Approved By: |
10) Control Plan
Customer:- | Customer code:- | Other Approval /Date (if Reqd.) | Other Approval / Date:- | |||||||||
Characteristics | Methods | |||||||||||
Process Name/ | Machine,Device, | No. | Product | Process | Special | Product/Process | Evaluation | Samples | Control Method | Reaction Plan | ||
Part/Process | Operation | Jig,Tools | Char. | Specification/ | Measurement | Size n | Freq. | |||||
Number | Description | For Mfg. | Class | Tolerances | Technique | |||||||
a – Stop Production, b – Notify Supervisor, c – Re-adjustment, d – Seggregate previous batch, e – Quarantine non-conforming parts, f – Tool Rectification | ||||||||||||
Prepared by :- | ||||||||||||
Approved by : | ||||||||||||
Revision History |
11) Process flow diagram
Part Name : | Customer:- | Revision : | |||||||
Part No./Latest Change Level: | PPD BY : | ||||||||
OPN No. | Fabricate | Move | Store | Inspect | Operation Description | Item No. | Key product / process characteristics | Key Control Characteristics | |
product | Process | ||||||||
12) Floor Plan Check list
CUSTOMER OR INTERNAL PART NO. :-
QUESTION | YES | NO | COMMENT/ ACTION REQUIRED | PERSON RESPONSIBLE | DUE DATE | |
1 | Does the floor plan identify all required process and inspection points? | Yes | ||||
2 | Have clearly marked areas for all material, tools, and equipment at each operation been considered? | Yes | ||||
3 | Has sufficient space been allocated for all equipment? | Yes | ||||
Are process and inspection areas: | ||||||
4 | Of adequate size? | Yes | ||||
5 | Properly lighted? | Yes | ||||
6 | Do inspection areas contain necessary equipment and files? | Yes | ||||
Are there adequate: | ||||||
7 | Staging areas? | Yes | ||||
8 | Impound areas? | Yes | ||||
9 | Are inspection points logically located to prevent shipment of nonconforming products? | Yes | ||||
10 | Have controls been established to eliminate the potential for an operation, including outside processing, to contaminate or mix similar products? | Yes | ||||
11 | Is material protected from overhead or air handling systems contamination? | Yes | ||||
12 | Have final audit facilities been provided? | Yes | ||||
13 | Are controls adequate to prevent movement of nonconforming incoming material to storage or point of use? | Yes |
13.0 Measurement System Analysis(MSA) Plan / Study Results
Part Name:
Part Number:
Customer:
S.No. | Instrument & ID No. | Range | Resolution (Least Count) | Characteristics | Spec of Part | Reason for MSA* | Type of analysis | Observed Results | Action, if any | ||
R&R | Bias/ Linearity | R&R | Bias/ Linearity | ||||||||
14.0 PpK and CpK PLAN / STUDY RESULTS
Part Name: Part Number:
Customer:
Sr. No | Product Characteristics | Reason for Identifying | Stage & M/C (Operation) | Results of Cpk / Ppk Study | Action, if any |
NOTE: Refer FMEA/Control Plan and ensure that for all Special Characteristics, Ppk must be identified.
1) Ppk / Cpk are applicable only for such operations which are stable.
2) For unstable processes, 100 % inspection is carried out.
Signature
14.0 PRODUCT / PROCESS QUALITY SYSTEM REVIEW
Part Name: Part Number:
Customer:
SR No | Expected Modifications | Required Yes / No | If Yes, Action Reqd | Responsibility | Remarks |
1 | Any Change in Documentation : – Manual – Procedures – Work Instruction – Control Plan – Inspection Std. – Process Control Sheet | ||||
2. | Changes in the Materials Storage Systems | ||||
3. | Change in the Inventory Norms | ||||
4. | Change in the Material Handling Systems | ||||
5. | Any Training required for new instruments being taken | ||||
6. | Any Modification in the existing processes | ||||
7. | Additional SPC tools to be used | ||||
8. | Mistake Proofing required, if any | ||||
9. | Change in Plant Layout | ||||
10. | Any Change in the Purchasing System | ||||
11. | New Vendors to be developed | ||||
12. | Modifications in the Internal Audit Schedule | ||||
13. | Any other not referred above: |
(Signature)
15 Process Sign Off Sheet
SUPPLIER: | PROGRAM: | ||||||||||
MFG LOCATION: | CHANGE LEVEL (S): | ||||||||||
PART NUMBER (S): | PRE-PSO MEETING DATE | ||||||||||
PART NAME (S): | ISO CERT. # TS CERTIFICTE # ISO 14001CERT. # EXPIRATION DATE: | ||||||||||
EARLY CONTAINMENT REVIEWED YES NO | |||||||||||
PSO PROCESS ELEMENTS VERIFIED | DOCUMENTATION | PROCESS | |||||||||
ACCEPT | UNACCEPT | ACCEPT | UNACCEPT | ||||||||
1 | PART NUMBER, DESCRIPTION AND CHANGE LEVEL | ||||||||||
2 | PROCESS FLOW DIAGRAM AND MANUFACTURING FLOOR PLAN | ||||||||||
3 | PROCES FMEA | ||||||||||
4 | ERROR AND MISTAKE PROOFING COMPLETE | ||||||||||
5 | PROBLEM SOLVING METHODS 8-D & 5-WHY | ||||||||||
6 | INCOMING AND OUTGOING MATERIAL QUALIF/CERT | ||||||||||
7 | TEST SAMPLE SIZES AND FREQUENCIES | ||||||||||
8 | PARTS PACKAGING AND SHIPPING SPECIFICATION | ||||||||||
9 | PARTS HANDLING PLAN | ||||||||||
10 | ENGINEERING STANDARDS IDENTIFIED | ||||||||||
11 | PREVENTIVE MAINTENANCE PLANS | ||||||||||
12 | GAUGE AND TEST EQUIPMENT EVALUATION | ||||||||||
13 | TOOLING, EQUIPMENT AND GAUGES IDENTIFIED | ||||||||||
14 | SPECIAL PRODUCT AND PROCESS CHARACTERISTICS IDENTIFIED | ||||||||||
15 | CONTROL PLAN | ||||||||||
16 | EVIDENCE OF PRODUCT SPECIFICATIONS | ||||||||||
17 | PROCESS MONITORING AND OPERATOR INSTRUCTION | ||||||||||
18 | LINE SPEED DEMONSTRATION | ||||||||||
19 | INTERNAL AUDIT | ||||||||||
20 | CUSTOMER SPECIFIC | ||||||||||
CORRECTIVE ACTION REQUIRED | YES | PROMISE DATE: | |||||||||
NO | |||||||||||
ALL PROCESS SIGN – OFF ELEMENTS APPROVED ? YES NO | |||||||||||
PROCESS SIGN OFF TEAM TITLE PRINT NAME & SIGN TITLE PRINT NAME & SIGN TITLE PRINT NAME & SIGN | |||||||||||
ALL CORRECTIVE ACTIONS ARISING FROM THIS PSO SHALL BE SUBMITTED TO THE CUSTOMER WITHIN THE PROMISE DATE SHOWN ON THIS FORM. |
16) Bill of Materials
Doc No : | |||||||
Part No : Drg.Rev.No : Part Name : Customer Name : | Rev No : Date: | ||||||
Page No : 1 of 1 | |||||||
Control status : | |||||||
BILL OF MATERIALS | |||||||
Sl.No | PART NO | DESCRIPTION | LEVEL | Drg.Rev. Status | Supplier | No.Off | units |
Prepared By : Approved By : |
17) Part Submission Warrent

18) BENCH MARK DATA / PRODUCT – PROCESS ASSUMPTION
Part Name: Part Number:
Customer: Person Contacted/ Interviewed, if any
Date of Visit:
A. Bench Marking Data
S. No. | Bench Marking Criteria | Bench Marking Data | Company’s Data (Similar Product) | |||
Supplier (Competitor) | Product | Data | Current Status | Assumed Target | ||
1.1 | Specific Applicable Features Requiring Attention : | |||||
a) | Productivity | |||||
b) | Cost / Unit | |||||
c) | Cost of Consumption of Consumables Per Unit | |||||
d) | Delivery Performance % | |||||
e) | Customer Satisfaction Index | |||||
f) | Plant Rejections % | |||||
g) | Re-works % | |||||
h) | Customer Returns | |||||
i) | Warranty Claims (ppm) | |||||
j) | Others (Specify) |
B. Product / Process Assumptions
2.1 | Specific Assumptions Related to Product Under Development: TechnologyMaterialsOperational Control / Features |
2.2 | The process of Bench Marking Partner (other supplier) and if the company needs the technological modification / acquisition. |
2.3 | Special Features of the process, (if Company does not have it). |
2.4 | Source of Acquisition if the Technology is new. |
Note : For Company’s Assumed Targets, make Action Plan (after feasibility is over) for achieving or exceeding the Bench Marking Data.
(SIGNATURES)
19) CHECK LIST FOR RELIABILITY & QUALITY GOALS
Part Name : Part Number :
Customer : Vehicle / Model:
A. Reliability Goals
S.No | Reliability & Safety | Requirements | |
Normal Conditions | Abnormal Conditions | ||
a. | Expected Life of development Product under different operating conditions | ||
b. | Safety Features (If any) |
ote: Use Bench Marking Data if any.
B ) QUALITY GOALS
(Make Action Plans for Achieving Targets)
Rejection at: Current Data Bench Marking Assumed Target
(Ppm / %) Similar (Product) (If any)
Customer End: —————— —————— ——————
End User : —————— —————— —————-
Car Mfr End : —————— —————— ——————
(OEM)
Different Stages of Production at Co. End
a) : —————— —————— ——————
b) : —————— —————— ——————
c) : —————— —————— ——————
d) : —————— —————— ——————
e) : —————— —————— ——————
(Signature)
20 ) CHECK LIST FOR MATERIAL SPECIFICATION
Part Name : Part Number :
Customer : Vehicle / Model:
S.No. | Check Point | Required | Comments / Action Required | Responsibility | Due Date | |
Yes | No | |||||
1. | Are Special Characteristics for materials been identified? | |||||
2. | Are specified materials, heat treat and surface treatments compatible with the product durability requirements? (For Design Companies only) | |||||
3 | Are the intended materials suppliers on the customer approved list? | |||||
4 | Will materials suppliers be required to provide Test Certificate / Report with each shipment? | |||||
5. | Have the materials characteristics requiring inspection been identified? If so: | |||||
a) | Will Characteristics be checked in-house? | |||||
b) | Is Test Equipment available? | |||||
c) | Will training be required to assure accurate result? | |||||
6 | Will Out-side Laboratories be used for the purpose? | |||||
7 | Are all Laboratories used accredited (if required)? | |||||
8. | Have the following materials requirements been considered? | |||||
a) | Handling | |||||
b) | Storage | |||||
c) | Environment during storage | |||||
d) | Identification during storage |
(SIGNATURE)
21) WORK INSTRUCTION FOR SPECIFIC PPAP REQUIREMENT
PURPOSE: To generate instruction for Customer Specific Requirements to perform PPAP Documents.
SCOPE: Applicable to all New Produced Parts, Correction of Discrepancy on previously submitted Parts & In case to change in part through Engineering change in design/specification/ material.
PPAP REQUIREMENTS:
Sr. No. | PPAP Documents | To Customers | From Suppliers | |||||
Level-1 | Level-2 | Level- 3 | Level-4 | Level-5 | Non ISO/TS | ISO/TS | ||
16949 | ||||||||
1 | Product Drawing | R | S | S | * | R | S | S |
2 | Product Specification | R | S | S | * | R | S | S |
3 | Engineering change documents, if any | R | S | S | * | R | S | S |
4 | Customer Engg. approval, if required | R | R | S | * | R | – | – |
5 | Process Flow Chart | R | R | S | * | R | – | – |
6 | Process flow diagrams | R | R | S | * | R | S | S |
7 | Process FMEA | R | R | S | * | R | – | S |
8 | Dimensional results | R | S | S | * | R | S | S |
9 | Customer Inspection Report (If Available) | R | S | S | * | R | S | S |
10 | Material performance Test results | R | S | S | * | R | S | S |
11 | Initial process study | R | R | S | * | R | – | S |
12 | Measurement system analysis studies | R | R | S | * | R | – | S |
13 | Qualified laboratory documentation | R | S | S | * | – | – | S |
14 | Control plan | R | R | S | * | R | S | S |
15 | Part submission warrant (PSW) | S | S | S | S | R | – | S |
16 | Appearance approval report,(AAR) If applicable | S | S | S | * | – | – | – |
17 | Sample product | R | S | S | * | R | S | S |
18 | Master sample If available | R | R | R | * | R | – | – |
19 | Packaging and Labelling Std & Logistics | |||||||
20 | List of checking aids for all drawing dimns | R | R | R | * | R | – | – |
21 | Records of compliance with customer- specific requirements | R | R | S | * | R | – | – |
22 | Sub Supplier PPAP (s) | |||||||
- If customer demands PPAP and does not specify level or requirements, Level 3 shall be considered as default level.
- Level 4 shall be followed if customer does not specify the level but gives only specific requirements.
- If customer does not demand PPAP, level 5 shall be followed.
* If required by customer.
R: Retain S: Submit
Perform only specific PPAP – if any of the following situations take place:
- When an Optional construction or material than the previously submitted part in used.
- When production is carried out using new or modified tooling (not the perishable tools).
- When there is any rearrangement/ refurbishment of equipment / tooling.
- When there is any change in process or method of manufacture that affects quality of end product.
- When production is carried out from equipment /tooling transferred to different plant / location on from an additional plant / location.
- When there is any change in source of subcontractor of non standard Part or material that affects end product quality.
- When a production is carried out with a tooling inactive for last 12 month or more.
- When there is any change in component or its process that affects end product quality.
- When there is any change in Test / inspection methodology / technique