The purpose of the procedure is to maintain a process for management of change (MOC). XXX ensure that quality management system is maintained when changes to the quality management system are planned and implemented. The potential risks associated with the change and any required approvals prior to the introduction of such changes are identified and addressed.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2020/ API Spec Q1, 9th edition
API Spec …
API Spec ….
API Spec ….
API Spec …..
API Spec …..
3.0 RESPONSIBILITY
Management Representative
Quality Systems Manager
All concerned process heads
4.0 INPUT:
Management of Change note, Corrective actions report
5.0 RESOURCES
Competent Manpower, Computers, Printer & Internet connection, XXX Procedures
6.0 DESCRIPTION
All members of the XXX, including Company, contractors and vendors are responsible for identification, communication and management of change. The changes that might affect quality of the product:
Changes in the organizational structure,
Changes in key or essential personnel,
Changes in crucial suppliers,
Changes to the management system procedures, including changes resulting from corrective and preventive action
It is important when reviewing a potential change, that each of the above ‘Key Areas’ is considered, as each one could be influenced by, and in turn affect, others. Also, the potential changes should be circulated around the company in an expeditious manner so that a positive and prompt response can be issued to the initiator of the change notice.
7.0 PROCEDURE
The early identification, communication of management of change are the responsibility of all members of XXX. The management of change review process is illustrated Figure 1. Once a potential change is identified, the initiator who can be an individual or department shall inform the MR and raise a management of change request form.
7.1 CHANGES TO PROCESSES
Management system processes will undergo changes, typically when:
Improvement opportunities have been identified, typically to improve process effectiveness
Nonconformities within a process are identified and require corrective action
Conditions in the industry or company change, requiring a process to be updated
New processes are added which impact on existing processes, requiring changes
Customer requirements result in a need to change processes
Any other reason determined by management
In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
At a minimum, process changes shall include the steps herein:
The request for a process change shall be documented, in Management of change format XXX/MR/16. The justification for the change shall be recorded.
The change shall be reviewed by appropriate management, including the senior most manager responsible for the process. Changes must be approved prior to implementation.
The appropriate process will be updated to reflect the change. This document will undergo review and approval per the procedure of Control of Document
The follow-up verification step of the CAR process shall seek to ensure the change has had the intended effect, and/or has improved the process. If not, the change may be rolled back or a new change made to correct any new issues that arise as a result of the change.
7.2 CHANGES TO PROCESS OUTPUTS
Where a process output is a document, the rules for changing documents above shall apply.
Formal changes to process outputs will be used when the change is significant. Minor changes may be made without formal control, however the decision on what constitutes a significant vs minor change must be agreed upon by those involved in the change. If a customer indicates a change is significant, this will trump any internal decision.
7.3 CHANGES TO DOCUMENTATION
Management system documents undergo changes when there is a need to revise them.
Changes to documentation are done in accordance with the procedure of Control of Document
7.4 CHANGES TO ORDERS OR CONTRACTS
Changes to active orders or contracts may occur when the customer changes the requirements after the work has begun, or may be initiated by XXX when unforeseen circumstances are encountered.
When changes are initiated by the customer, the new requirements will undergo the same review and acceptance per the procedure for Contract review. If the changes cannot be accepted by XXX a satisfactory solution will be negotiated with the customer.
When changes are initiated by XXX the Machine shop Manager will notify the customer and negotiate a resolution.
7.0 OUTPUT:
Management of change form, training plan, related actions
To determine and implement preventive actions, both internally and within the supply chain.
To eliminate the causes of non-conformities in-order to minimize the likelihood of its recurrence.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001:2020/ API Spec Q1, 9th edition
API Spec …..
API Spec …..
API Spec …..
API Spec …..
API Spec …..
3.0 RESPONSIBILITY
Management representative
All concerned process owners
4.0 PROCEDURE
The Management determines action to eliminate the causes to potential nonconformities in order to prevent their occurrence.
Preventive Actions are appropriate to the effects of the potential problems.
The preventive action requires the following:
Identifying the areas of improvement.
The effective handling of customer complaints and reports of actual non-conformances.
Reviewing of nonconformities including customer complaints.
Determining potential nonconformities and their causes.
Evaluating the need for action to prevent occurrence of nonconformities.
Determining and implementing action needed.
Identifying the timeframe and responsible person(s) for implementing a preventive action.
Preventive actions are implemented to prevent and eliminate non-conformance to a degree, appropriate to the magnitude of problems and commensurate to the risks encountered.
Records of the results of action taken.
Reviewing the effectiveness of preventive action taken.
MOC when the preventive actions require new or changed controls within the Quality Management System.
Preventive actions which are implemented are monitored and audited by the Management Representative & Quality Systems Manager to assess the effectiveness of the action taken.
Records of Preventive Actions taken are maintained and retained for five years.
4.1 Effectiveness Review on Preventive Action:
In XXX, effectiveness of the Preventive action taken is reviewed through a NC closure verification checklist.
Management Representative reviews effectively and may insist for more action, if required. This activity is subject to further evaluation at the time of the Management Review.
4.2 Areas of responsibility:
The management and all employee of the respective location are responsible for introducing preventive action in the company
All employees in departments, which influence product quality are obliged to:
Identify and eliminate potential non conformities
Introduce effective preventive measures and show that these are effective
4.3 Source of information:
It is necessary for appropriate sources of information to be checked so that potential cause of discrepancy can be recognised, analysed and eliminated.
Such sources are:
Quality data from processes
Data and trends from goods inwards inspection
Data on scrap material
Data on rework
Results of intermediary and final inspection and checking
Results of system, procedure and process audits
The Management Representative/Quality Systems Managereither carry out these checks himself or organise and assess them
Common problem solving methodologies like QC story, Fish-Bone diagrams are used to solve the problems.
The results of the problem solving methodology are documented appropriately by concerned personnel and these documents are subject to verification during MRM.
The purpose of the procedure is to establish a system for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. At XXX, Data analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 9001: 2020/ API Spec Q1, 9th edition
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec ….
3.0 RESPONSIBILITY
Management Representative
Quality Systems Manager
All concerned process heads
4.0 INPUT
Customer satisfaction Feedback
Customer Complaints
Audit Results
Conformity to product requirements.
Nonconformities and product failures identified after delivery or use.
External provider/Suppliers Performance
Quality objectives
5.0 RESOURCES
Competent Manpower, Computers, Printer & Internet connection, Stationaries, XXX Procedures
6.0 PROCEDURE
Management Representative reviews the data collected like customer complaints and identifies the statistical techniques for establishing, controlling and verifying process capability, product characteristics.
As soon as suitable technique is identified, it is used in the relevant area.
The analysis of data provides information relating to;
Customer satisfaction
Customer Complaints
Self – Assessment
Audit Results
Conformity to product requirements.
Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause
Characteristics and trends of process and products including opportunities for preventive action.
Suppliers Performance
Information on Quality objectives
Corrective actions taken are to ensure their effectives.
The Data Analysis record is maintained.
The data from the above is analyzed periodically (at least once in 3 months) and statistical report is prepared and submitted to the top management (CHAIRMAN) for information and necessary follow-up for the corrective action and continual improvement of the system/area.
Summary of the statistical analysis is produced in the Management Review Meeting.
6.1 CUSTOMER FEED BACK
Customer Satisfaction is detailed in procedure for Customer Satisfaction
6.2 CUSTOMER COMPLAINT
All customer complaints received within XXX are recorded in the customer complaint Record.
It is the responsibility of all managers and staff to report in case of receipt of any customer complaints to the Quality Systems Manager and Management Representative by forwarding such written complaints received from the client. In case of verbal complaints the concerned personnel records such complaint in the customer complaint Record or send a written note to the Management Representative.
The customer complaint is used as a tool for the verification of customer satisfaction. All customer complaints within XXX are logged in the customer complaint record and are subject to the verification of Management Representative, and a review of customer complaints is carried out periodically.
All personnel in XXX have the responsibility to inform the Management for any customer complaints reported verbally or in written format.
Each customer complaint is treated as Non-conformities within XXX and necessary corrective and preventive actions taken accordingly.
No of customer complaints/ or the frequency of customer complaints are monitored in weekly basis and the trend of NCs are reviewed accordingly.
Management Representative summarizes the above with the status of corrective and preventive action and furnish the same for the Management Review.
6.3 VERIFICATION OF CONFORMITY TO PRODUCT REQUIREMENT
XXX realize that the product conformance are the results of using right personnel on right job, using right material, machinery, tools etc., and well understanding of customer requirements. All personnel performing product manufacturing or providing services are trained to carry out their task in order to meet the product service requirements.
This requirement is being monitored during various stages of the manufacturing process or service by the supervisors and Inspection personnel.
Training needs and records are verified during Management Review Meetings once in 12 months.
All production equipments are checked periodically and monitored for its fitness for the intended use. All measuring equipments are calibrated, validated and checked prior to use. Records are maintained for historical review.
Deviations and non-conformities, trends of NCs, reasons, occurrence and recurrence are recorded and verified periodically, and necessary corrective action and opportunities for preventive measures are verified accordingly.
6.4 SUPPLIER OR SUB-CONTRACTOR VERIFICATION
In order to maintain the product/service quality, XXX has to be aware of the performance of the vendor/supplier/ sub-contractor that can be managed within this Quality Management System.
XXX follows an approved vendor/subcontractor list and the suppliers and sub-contractors are reviewed once in 12 months.
Data pertaining to each supplier or subcontractor are maintained in the Procurement Department.
7.0 OUTPUT
Analysis of Customer feedback, analysis of Supplier performance, Quality objectives status, Analysis of Audit Results, Conformity to product requirements.
8.0 KEY PERFORMANCE INDICATOR
All analysis done and related action plans & corrective actions
To identify the controls and related responsibilities and authorities for addressing non-conforming product
To address detected non-conformities
To take action to preclude its original intended use or delivery
To authorize its use, release, or acceptance under concession by relevant authorities.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2020/ API Spec Q1, 9th edition
API Spec 6A
API Spec 16A
API Spec 5CT
API Spec 5DP
API Spec 7-1
3.0 RESPONSIBILITY
Management Representative
QA/QC Engineer
All concerned process owners
4.0 INPUTS
Final Product/output inspection
5.0 RESOURCES
ALL MMEs, trained man power Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions
PROCEDURE
The nonconforming Materials during receiving, in-process and final inspection are identified and corrective actions are taken as appropriate.
The nonconforming Materials are dealt with and reviewed by QA/QC Engineer.
The review includes the following.
By taking action to eliminate the detected nonconformity.
By authorizing its use, release or acceptance under concession by a relevant authority and where applicable, by customer.
By taking action to preclude its original intended use or applicable.
By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product/output is detected after delivery or use has started.
Non-conforming product are identified, by means of attachment of a yellow sticker, documented and after evaluation are segregated, to ensure un-authorised use is not permitted prior to disposition action.
Disposition of non-conforming material is made at inspection level, which ensures that where notification to functions affected is required and it can be achieved.
When nonconforming product/output is corrected, that product/output is subjected to re-verification to demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken including concessions obtained are maintained.
The product/output that does not satisfy the original customer acceptance criteria satisfies that changes / new customer acceptance criteria.
The details of nonconformity and repairs are recorded and maintained.
The repaired or reworked product/output is re-inspected and records are maintained.
6.1 Responsibility
All department managers and their staff are responsible to implement this procedure in order to attain its objective.
It is the responsibility of QA/QC personnel to identify the non-conforming material immediately after inspection and notifying to the concerned personnel (production/or store).
Production personnel are responsible for segregating or where segregation is not possible, clearly identified and stopped for further processing unless the procedure for disposition action being established. (Refer: Master List of Independent Inspection Personnel)
Storekeeper is responsible for segregating, where possible and following with the concerned supplier/or procurement for disposition action.
The QA/QC Engineer is the final authority of XXX to accept any non-conforming material based on the application and design/product acceptance criteria. The QA/QC Manager may contact the concerned authority (customer/design engineer) for acceptance of such, when required.
6.2 Non Conformance after product delivery:
The procedure for addressing non-conformance after delivery of product includes:
Identification of customer complaints otherwise referred as field non-conformances. .
The customers are notified in the event that product/output not conforming to customer acceptance criteria has been delivered and such notification records are maintained.
The customer complaints are handled by Manager QA/QC and records are maintained. (Refer :Customer Complaint Record – XXX/QA/14)
If the product is under the warranty period, based on the nature of complaint, the course of action towards the satisfactory completion of the complaint is initiated.
The customer is informed in writing about the course of action and if required suitable person is deputed to the customer’s site to attend the complaint.
The customer’s complaint and root cause of nonconformance is analyzed and corrective action is taken suitably to minimize recurrence of similar problems in future.
6.3 IDENTIFICATION
All non-conforming materials are identified in accordance with this procedure and are recorded in the NCR.
Non-conforming materials awaiting disposition action are identified by yellow sticker (“NON-CONFORMING”) or attached with a round yellow sticker on the material identification card.
Non-conforming material, which cannot be rectified or utilised within the system is identified by red sticker (“REJECTED”) or attached with a round red sticker on the material identification card.
All non-conformance materials are to have non-conformance report filled with disposition action and are followed accordingly.
6.4 REVIEW AND DISPOSITION OF NON-CONFORMING PRODUCT/OUTPUT
The QA/QC Engineer is responsible for the review of non-conformity of the product/service or the quality system. On behalf of the Chairman, the QA/QC Engineer has the authority and organizational freedom for the disposition action.
All non-conforming product are reviewed in accordance with this Procedure/Contract Technical requirement/or the product/output manufacturing specification (including API-specification and standards).
Where the disposition action established is either repaired or re-work, acceptance with or without repair by concession, the product/output is regarded for alternative applications, or rejected/scrapped.
The QA/ QC Engineer have to agree on disposition, concession or uplift of the non-conforming product/output or return of the non-conforming product/ output to the supplier or company stores. Details of the disposition action taken are recorded on the relevant inspection reports and/or NCR.
Where required by the contract, the proposed use or repair of product/output which does not conform to specific requirement is reported for concession to the customer or customer’s representative. The description of non-conformity that has been accepted and of repair is recorded to denote the actual condition. All such records are maintained in accordance to Manual.
Repair and/or reworked product are re-inspected in accordance with the quality plan and/or documented procedure.
6.5 Records
XXX has maintained the records of non-conformities and any subsequent action taken, including concessions obtained in the Non-conformance Product Report.
To determine testing, monitoring, measuring requirements and the equipments needed to provide evidence of conformity.
To ensure that testing, measurement and monitoring equipment is calibrated and maintained and that the equipment is used in a manner that is consistent with monitoring and measurement requirements.
To establish the criteria to calibrate process control instruments, weighing equipments, laboratory equipments and calibration equipments in accordance with the relevant specifications and national / international standards.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2020/ API Spec Q1, 9th edition
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec ……
Applies to all processes which has an influence on product quality.
RESPONSIBILITY
QA/QC Engineer
All concerned Personnel
2.0 INPUT
All MMEs
Calibration procedure & Specifications,
Calibration schedule/ Calibration methods
3.0 RESOURCES
Competent & Experience Manpower, XXX Procedures/QIPs/ Work instructions
Advance Instruments / equipment for carrying out Inspection & Testing,
In-house Masters for Internal calibration
4.0 PROCEDURE
It is the responsibility of the QA/ QC Engineer to ensure that all test equipments are adequately calibrated traceable to National/International Standards.
It is the policy of XXX to maintain the accuracy and reliability of its inspection and measuring equipment/ tools at a level acceptable within the calibration appropriate to their tolerances by calibrating them as scheduled.
4.1 CALIBRATION PLAN
QA/QC Engineer verifies the Master list of Monitoring and Measuring Instruments to ensure the frequency, date of calibration, due date of calibration and status of all the equipments requiring calibration.
Calibration interval is identified for all the measuring equipments as per the international standard requirements.
Sl. No.
Equipment/or Instrument
Calibration Interval
Mode of Calibration
1
Vernier Caliper
Every six months
Internal
2
External Micrometer
Every six months
Internal
3
Internal Micrometer
Every six months
Internal
4
Depth Micrometer
Every six months
Internal
5
Vernier Height Gauges
Every six months
Internal
6
Dial Indicator
Every six months
Internal
7
Surface Table
Every six months
Internal
8
Engineer’s Level
Every six months
Internal
9
Electrode Oven
Every six months
Internal
10
Slip Gauges
Every One year
External
11
Pressure Gauges and Recorder
Every three months or before use
External/Internal
12
Temperature Recorders
Every three months or before use
External
13
API Thread Ring & Plug Gauges
First Re-calibration after 1000 engagements and subsequent every after 500 engagements
Internal/External
14
API Thread Plug Gauges
First Re-calibration after 1000 engagements and subsequent every after 500 engagements
Internal/External
15
Tong Tester
Every One year
External
16
Precision Level
Every six months
Internal
17
Bore Gauge
Every six months
External
18
Ball Trammel Gauge
Every six months
Internal
19
MPI Yoke
Every six months
Internal
20
Noise Meter
Every One year
External
21
PWHT Temperature Controller K-Type
Every Three Months
External
22
Snap Gauge
Every One year
External
23
Bevel Protractor
Every six months
External
24
Hilo Gauge
Every One year
External
25
Weld Gauge
Every One year
External
26
Dew Point Meter
Every One year
External
27
Infrared Thermometer
Every One year
External
28
Hardness Tester
Every One year
External
29
Lux Meter
Every One year
External
30
Measuring Tape
Every One year
External
31
Welding Rectifier
Every six months
Internal
32
PWHT Furnace
Every One year
Internal
33
Yoke Calibration Block
Every One year
External
34
Digital Thermometer
Every One year
External
35
Digital Thermocouple
Every One year
External
36
Step Block
Every One year
External
37
Humidity Meter
Every One year
External
38
Micrometer Setting Rod
Every One year
External
39
Ultrasonic Thickness Gauge
Every One year
External
40
Drift
Every six months
Internal
41
Dial Caliper
Every six months
Internal
42
Paint/Foil thickness Gauge
Before use
Internal
43
API Taper Gauges
Every after 1000 engagements
Internal
44
Master Gauges Plug and Ring
Every after 250 engagements
External
45
External Dial Caliper
Every six months
Internal
46
Internal Dial Caliper
Every six months
Internal
47
API Profile Gauges
Every after 1000 Connections
Internal
As per API Spec. 7-2 Sec.10.3.1.5.2 – Regional and reference master gauges are retested for mating and interchange standoff at least once each seven years, and certified on a certificate of retest as being acceptable for further use. API working gauges setting rods and others shall be segregated into adjustable and non-adjustable as per API 5CT clause 8.2 para 4.
4.2 GENERAL CALIBRATION REQUIREMENTS:
Unless, otherwise specified, monitoring and measuring equipment is calibrated to manufacturer’s specifications. If no specifications are available, the equipment is calibrated based on intended use.
The specifications for calibration must be reviewed, planned and validated by QA/QC Engineer.
Environmental Condition to be maintain as per requirement.
Temperature Range: 23°C±5°C
Humidity Range: 20 to 80 % RH
Calibration requirements are documented in the calibration certificates for the individual instrument / instrument type.
4.3 INSTRUMENT RECEIPT:
All monitoring and measuring equipment must be received, reviewed, verified, and approved by QA/QC Engineer before it can be used in production or inspection reject/accept decisions.
4.4 INSTRUMENT IDENTIFICATION:
All inspection, measuring and test equipment are have a unique identification number and details relating to each piece of equipment is recorded in the Master list of Monitoring and Measuring Equipment.
All master equipment for calibration also has a unique Identification Number and has the calibration traceable to National/ International Standard (e.g. NAMAS). Calibration reports of master equipment are maintained separately with the list of Monitoring and Measuring Instruments.
Identification is made either by engraving the unique identification on the equipment or by labeling (fixing the identification number by a label/sticker).
Upon completion of the calibration, the status of calibration is identified by fixing a calibration sticker. Calibration sticker has the date of calibration, calibration due and certificate number.
All non-conforming instrument/equipment is identified by red sticker and is segregated.
In order to identify the Product inspected by a particular Equipment/instrument, that equipment/instrument is logged in a register with the following information:
Date of use
Job/contract number
Operator Name
All instruments (not fitted with equipment/machines) are stored in the gauge room and the calibrated equipment/instruments are stored separately without mixing with the instruments not calibrated.
4.5 HANDLING & STORAGE:
Personnel handling, transporting, or storing monitoring and measuring equipment must ensure that care is taken to prevent damage or deterioration to the equipment. If personnel are not familiar with the use or application of equipment, they are responsible for asking their supervisor and/or QA personnel for training.
In case the QA personnel not available, the users should follow the user manual provided with the equipment for doing monitoring and measurement activities.
4.6 OUTSIDE SUPPLIERS:
For calibration preference of suppliers is to those who hold ISO/IEC 17025 certification, but is made based on their technical competence. QA/QC Engineer is responsible for ensuring that outside calibration service providers are on Approved Supplier List.
4.7 CALIBRATION PROCEDURE (Internal)
All measuring and test equipment which can be calibrated internally (within XXX) have calibration procedure and is demonstrated accordingly (Level III – Quality Internal Procedures).
Trained/Qualified personnel are conducted the calibration to safe guard the inspection, measuring and test facilities from adjustments, which would invalidate the calibration setting.
XXX operates detailed Level III procedures, which specifies the process employed for the calibration of inspection, measuring and test equipment including detail of equipment type unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory.
4.8 CALIBRATION PROCEDURE (External)
On receipt of the calibration recall instruction from the Quality System Manager, the QC Engineer checks the calibration status of the all measuring and monitoring devices.
A list to be prepared for devices which are due for calibration by the QC Engineer and the measuring and monitoring devices are collected and delivery note is prepared by the store keeper. The physical condition of the measuring and monitoring devices to be checked by QC Engineer before sending them for calibration.
The measuring and monitoring devices is sent to the approved calibration providers through Machine shop driver.
The driver is responsible for delivering the measuring and monitoring devices to the calibration provider and bring acknowledgement of the same.
Once the measuring and monitoring devices are calibrated, it is collected by the driver along with original invoice.
The driver is responsible for delivering the measuring and monitoring devices and their calibration certificates to the QC Engineer.
It is the responsibility of QC Engineer to check the accuracy and correctness of the calibration certificates and if any deviations report immediately to the service provider. Also the QC Engineer will examine the physical condition of the measuring and monitoring devices once it is back from calibration.
Original calibration certificates are to be filed in the calibration certificates files and a copy to be maintained with the QC Engineer. Accordingly the master list of measuring and monitoring instruments to be updated by the QC Engineer.
Then the measuring and monitoring devices is send to the production with calibration sticker.
The same methodology is followed for customer provided measuring and monitoring devices.
4.9 CALIBRATION RECORDS:
All calibrated instruments (externally or internally) have a calibration certificate issued by the authority (internal or external). In house calibration is recorded in the in-house calibration certificate. (Refer XXX / QA / 16).
Calibration certificate have the following:
Date of calibration
Equipment details
Reference procedure with issue and revision status
Calibration data (any out of specification reading as received for calibration/verification and an assessment of the impact of out of specification)
Name and Signature of the calibration performed
Status of calibration is recorded in the Master list of Monitoring and Measuring Instruments.
Where inspection measuring and test equipment is found to be nonconforming but still within its calibration period, the equipment is labeled with ‘Red sticker’ and held as segregated.
An assessment of the equipment is undertaken and appropriate rectification is taken
Any inspection, measuring and test equipment found to be suspected, the suspected equipment is automatically segregated and re-inspected to re-establish conformance in accordance to the inspection requirements
It is the responsibility of the QA/ QC Engineer or his Designated Engineer to arrange recall of the units due for calibration.
All calibration records are maintained with Quality Assurance Department.
All calibration records of monitoring and measuring equipment is maintained by the QA/QC Engineer and retained for a minimum of 5 years.
4.10 OUT OF TOLERANCE CONDITIONS:
If any monitoring and measuring equipment is found to be out of tolerance during calibration, the monitoring and measuring equipment is reviewed for possible impact on measured product since the equipment’s last known acceptable calibration/verification.
The QA/QC Engineer, or delegate, must make a determination as to the appropriate action required concerning use of the equipment and any product potentially affected by its prior use (use as it is, scrap, recall, etc.)
A notation of actions taken on equipment and product is maintained in the calibration files.
The QA/QC Engineer must provide a copy of the equipment’s calibration history at the time of review.
Equipments which are considered as out of calibration/damaged/lost will be recorded in the Non-calibrated / Scrap equipment Record.
4.11 NON-CONFORMING MEASURING EQUIPMENT:
Any confirmed measuring equipment that is suspected or known to be damaged, malfunctioning in such a way to invalidate its intended use, producing incorrect measurement results, safeguard broken or damaged, or otherwise considered unfit for use must be removed from service and segregated or identified in such a way to prevent its use.
This is done by performing the following:
By marking the instruments inactive in the calibration files.
Record the date, reason for defect, replacement status, and whether any product has been affected and why.
Place a Not in Use on the non-conforming equipment until disposition.
Equipment cannot be returned to service until the reasons for its nonconformity have been eliminated and its full function has been confirmed, or it is designated for ‘limited use’ only. If the instrument is sent out for repair, the supplier also calibrates the equipment.
Accompanying documents is reviewed upon its receipt to ensure that calibration was completed.
If the instrument is replaced, a new entry with a new instrument number is created in the calibration list. The nonconforming instrument remains inactive.
4.12 LIMITED USE:
If any equipment is not functioning to its full capabilities, but is acceptable for limited or other use, this information must be clearly identified and apparent for the operator/user. For example, this could be used for ‘reference only’ measurements.
4.13 LOST INSTRUMENTS:
Any instrument that cannot be located at the calibration due date require the notification of the process In-charges. Instruments that cannot be located for a period exceeding 2 months requires notification of the QA/QC Engineer.
4.14 TRACEABILITY:
All calibrations are traceable to the International Standards.
Master list of all Monitoring and Measuring Equipment’s (MMEs) is established containing the following:
Equipment Description
Identification Number
Range
Acceptance Criteria
Adjustable/Non-Adjustable
Location
Interval of Calibration/verification
Calibration/verification responsibility (External or In-house)
The interval of calibration/verification is determined based on the type of MME and frequency of usage.
The MMEs are calibrated either in-house or by the approved external laboratories. In case of in-house calibration/verification, the calibration/ verification is carried out as per work instructions.
All newly procured MMEs are submitted to QA/QC Engineer for registering in the Master list. The QA/QC Engineer ensures the availability of the calibration certificate for the new MME or otherwise ensures issuance only after calibration
If the deviation of the measurement is affecting the product quality, the components produced using this MME are traced and is re-inspected. In case the components/ products are already dispatched, the customer is intimated regarding the same and the necessary action is taken.
4.15 MONITORING AND MEASUREMENT OF THE PROCESS
The QA/QC Engineer verifies timeliness of re-calibration / verification to check the process effectiveness.
When the equipment is provided from a source external, including third-party, proprietary, employee and customer-owned equipment, XXX / QC verifies that the equipment is suitable and provides evidence of conformity to the requirements of this section.
XXX maintains a registry of Monitoring and Measuring Equipment of the required testing, measurement and monitoring equipment used to determine product conformity to requirements
The purpose of this procedure is to outline the methodology for the establishment of preventive maintenance for equipment used in product realization and also to be followed for attending any maintenance activities on key process equipment / machinery at XXX.
2. SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2022/ API Spec Q1, 9th edition
API Spec ….
API Spec ….
API Spec …..
API Spec …..
API Spec …..
Applies to all processes which has an influence on product quality
The Preventive Maintenance of equipment and machinery is carried out to ensure the continuing process capability.
Machinery is classified as product machinery and Utilities.
Annual Preventive Maintenance Plan has been prepared for product machinery and addressed for all the machines, specified in the Master list of Machines, with requirements for type of equipment is maintained
Machine shop Supervisor/Foreman assigns the work and carries out preventive maintenance as per Preventive maintenance schedule of all machines.
Daily / weekly / monthly / quarterly / half-yearly and annual Maintenance checklist is prepared for all the Machines specified in the Master list of Machines.
Using Preventive Maintenance Checking Parameters, all the parameters to be checked, reviewed and approved by concern personnel and are then specified in the Preventive Maintenance checklist.
It should be considered the manufacturer’s recommendations susceptible failures gathered from work experience of the machine.
Breakdown Maintenance to be carried out as per QMS. Breakdown related to critical issue and/or in certain cases where Top Management involvement is required then Breakdown maintenance report to be prepared by Supervisor/Foreman, reviewed by Machine shop Manager and approved by Chairman
Minor breakdowns shall be recorded in the Breakdown Register.
Records of preventive maintenance are maintained minimum of 5 Years.
Preventive maintenance is performed based on Machine Manual, risk, system reliability, usage history, experience, industry recommended practices, relevant codes and standards, original equipment manufacturer’s guidelines, or other applicable requirements.
To verify that product requirements have been met.
To describes the requirements for in-process and final inspection and testing.
To define in detail the various steps to be initiated for the inspection and testing of raw materials and finished products for achieving process control and optimum quality Control.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2020/ API Spec Q1, 9th edition
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec ….
Applies to all processes which has an influence on product quality
3.0 RESPONSIBILITY
QA/QC Engineer
Operations Engineer
Machine Shop Manager
All concerned process owners
4.0 INPUT
Requirements for in-process and final inspection and testing
Production & Quality plan
Inspection & Test plan
5.0 RESOURCES
All MMEs, Trained Manpower, Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions
6.0 PROCEDURE
XXX maintains a documented procedure for inspection and testing to verify that product had met the requirements.
6.1 IN-PROCESS INSPECTION AND TESTING
Production & Quality Plans or written instructions/route sheet identify all ‘hold’ points during the production process where inspection, testing and identification is required. This is accomplished through inspection and testing, process monitoring or sampling to a specified sampling plan.
Acceptance of the above, are identified by signing the document by the concerned inspection authority. (QA/QC Engineer)
No material is moved to the next process station until the above verification is completed unless under a ‘positive recall’ method.
Non-conforming ‘in-process’ material are identified as above and the material is quarantined awaiting disposition, in accordance with this quality procedure.
In case of site operation the in process inspection may be managed by an Inspection Release Note or other release note or inspection clearance acceptable to the customer.
6.2 FINAL INSPECTION AND TESTING
All product manufactured by XXX have a final inspection and testing to validate the conformance of the product to the manufacturing specification requirement and customer specification in accordance with the product quality plans.
Personnel other than those who performed or directly supervised the production of the product is (i.e. QA/QC Engineer) to perform the final acceptance inspection at planned stages of the product realization process.
6.3 HARNESS SURVEY
6.3.1 REQUIREMENTS FOR HARDNESS SURVEY
The hardness inspector derives instructions from QA/QC department to conduct hardness inspection.
Hardness testing is done as per procedure.
6.3.2 INSPECTION AND WITNESSING
The QA/QC Engineer is responsible to identify and mark up punch location of the equipment.
QA/QC Engineer obtains current version RRIR sheet from QA/QC Engineer and/or Production In charge.
QA/QC Engineer is required to witness all punches, record them into RRIR sheet after conversion by using Brinell Hardness Chart and endorse them with his signature and date.
There should not be any form/register for recording hardness readings.
The reading recorded along the punch is not taken into consideration.
RRIR sheets, once endorsed by QA/QC Engineer are filed back in the job folder.
Readings are subject to final approval from QA/QC Manager/Operations Manager.
6.3.3 EQUIPMENT
Hardness Testing is conducted using XXX hardness tester and a hammer of more than Kg 1 is used.
Equipment should be cleaned prior to and after its use
Periodic Inspection of the equipment is done by QA/QC dept. to ensure validity of the results obtained.
Equipment is stored in the gauge room, at a secure place
Hardness pins (carbide pin) is reordered by writing a material requisition to the stores in charge.
6.3.4 HEALTH, SAFETY AND ENVIRONMENT
Refer to XXX HSE manual.
6.3.5 PERSONNEL
Only qualified personnel are given the responsibility of hardness test.
Personnel qualification is done by QA/QC Engineer by training and examination.
Requalification of personnel is due every 365 days of the last qualification.
Records are maintained.
6.3.6 NON-CONFORMANCES
Initial and final hardness reading recorded is checked for compliance with Hydril/GE acceptable ranges.
In case of deviations, Nonconformance report is raised, and communicated to all concerned including customer.
Equipment is marked/tagged red and moved to NC area with in machine shop until rework.
6.4 INSPECTION RECORDS
Inspection records are maintained to reflect the status of the product at all stages which include:-
Records of Incoming Material (Material Receiving Inspection Report & Store Receipt Voucher)
Records of In-process Inspection (Production & Quality Plan and Release Notes)
Records of Final Inspection (Work Shop Report, Dimensional Report, Hardness Test Report, Pressure Test Reports, Liquid Penetrant Report) and when on Project/site operations this is replaced by “Completion Report”
Inspection records are treated as quality records and are retained as per the L2 – 04 Control of Records.
This purpose defines requirements and methods for:
Describing the methods used to preserve the product and constituent parts throughout product realization and delivery to the intended destination in order to maintain conformity to requirements.
Identification & traceability, handling, storage, packaging, preservation and delivery of materials and products.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
ISO 29001: 2020/API Spec Q1, 9th edition
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec …..
Applies to all processes which has an influence on product quality. This procedure applies to all persons who handle, store, package, and deal with the preservation and delivery of the product.
3.0 RESPONSIBILITY
Store Keeper
Machine Shop Manager
All concerned personnel
4.0 INPUT:
Receipt of Raw Material along with relevant documents
Material requisition from User department
Customer orders / Dispatch intimation from production
5.0 RESOURCES:
Storage Space for Material, Material Handling equipment, MME, Trained manpower, Computers, Printer & net connection, XXX procedures
6.0 PROCEDURE
It is the responsibility of the Machine Shop Manager to maintain all equipment, tools, consumables, instruments, material etc. within their supervision.
It is the responsibility of store personnel to maintain and control all items within their control.
All company assets in the labour camp are controlled by the Camp Supervisor.
All master equipments, codes, standards, code symbol stamp, monogram stamp are controlled by QA/QC Engineer.
All original certificates of license and qualification of the company, approvals/pre-qualifications and Quality Certifications are maintained with Personnel and Admin Manager
In case of any equipment, tools, standards, codes, instruments, vehicle etc. are issued to an individual; it is the responsibility of such individual to maintain the particular within his/her control.
6.1 HANDLING OF PRODUCT
The handling of product within the company is executed in such a manner to minimize and/or prevent any damage to the product. The methods and measures of preventing damage to product during handling include:
Wherever required a special handling procedure is prepared and followed accordingly.
Providing training to the appropriate employees operating cranes, forklifts etc. and maintaining a clear and unobstructed handling environment within the designated staging and storage areas.
Ensuring and trying to utilize existing storage space in such a manner that it facilitates safe retrieval and removal/transfer of product. Safety and Hazardous Materials training (where appropriate) is provided to the employees to ensure that the handling of potentially unsafe and/or unwieldy products(s) is performed in such a manner that prevents damage to both employees and product.
Any other means or methods deemed appropriate by the functional supervisors and/or employees to ensure product is handled safely.
6.2 STORAGE OF PRODUCT
Incoming raw materials, fittings, hardware’s tools etc., are stored in the designated area after it is inspected and cleared by Authorized Personnel until allocated for production.
The storage area is maintained in such a manner as to prevent any damage to the materials and finished product.
Secure storage area or racks are provided to prevent damage or deterioration to product while still in the custody of XXX until delivery to the desired destination or at customer premises.
All materials in storage have a proper identification and clear test status based on the type of material (stock item or finished products). Materials without QC acceptance are not to be retained within the store or segregated.
Products in stock are checked continuously and assessed in appropriate intervals to detect conformance to quality requirements. This is done monthly/quarterly /half-yearly for items/Products where chances are there of quality getting deteriorated over the period of time in the storage. For such products the sample is checked by QC and if found as per Quality requirements material is retained in the store for use. If product is found not meeting Quality requirements same is put under rejection/Hold area as per Non-conforming product procedure and necessary action is initiated.
The Monthly assessment is also done for Products / Material having limited shelf life. The Stores Keeper shall prepare list of Material having shelf life, if any, along with validity and same will be checked once in three months. During the assessment if material is found with shelf life expired then same material is subjected to QC inspection / Testing and if found meeting quality requirements same is retained in the stores for further use. If any material is found with shelf life expired and not meeting quality requirements same is rejected and non-conforming product procedure is followed.
Records of assessment are maintained.
Materials and equipment’s are normally stored according to the storage condition recommended by the manufacturer or as per the good working practice.
Access to the storage areas are limited to authorized and trained employees.
The Material Controller is responsible for the assessment of real and potential deterioration of the product.
To detect deterioration, the condition of product or constituent parts in stock are assessed periodically and top management uses an inventory management system to optimize inventory turn overtime and assures stock rotations, such as first-in-first-out.
Stored material is packaged and preserved in a manner to prevent damage and deterioration while in storage. The process heads takes appropriate action in accordance with Corrective & Preventative Action, if necessary.
All purchased materials are identified by MRIR No. All fixed assets have an asset number allocated and are identified on both equipment and the asset records.
The customer supplied materials and material procured in petty cash need not be logged in the store system. But, the SRV are prepared for all customer supplied material. Any permanent item (not spare parts) purchased through petty cash is to be logged in to the store system.
Customer proprietary product are stored in a controlled secured area so that it is prevented from being sold or provided to third parties without the customers’ written authorization.
The products should not come in contact with solvents and contaminants if any and should be stored in unstressed condition with poly bags / crates with labels.
6.2.1 STORAGE OF RUBBER GOODS:
Keep the rubber storage area as dark as possible- preferably indoors and away from direct sunlight, skylight, windows and direct artificial lighting, the ultraviolet content of the light spectrum accelerates cracking.
Select a cool location (ideally below 90◦ F) that is away from heaters, stoves and direct blasts of space heaters. Heat causes a gradual hardening of rubber goods. The process is greatly accelerated when ozone or oxygen is present. In extremely cold climates, some rubber goods become so brittle they will shatter when dropped or handled roughly.
Keep rubber goods away from electrical machinery (motors, switch gear or any high voltage equipment producing corona). Avoid locations susceptible to drafts that will carry the atmosphere from electrical machinery to rubber goods storage area.
Expose to the atmosphere allows oxygen and thus ozone (O3), a very active form of oxygen, to react with and be especially detrimental to rubber goods. Two principle sources of ozone are (1) atmospheric ozone and (2) ozone created by electrical discharges such as lightning, high voltage corona and electrical machinery. Points of strain in rubber goods attacked by ozone are characterized by deep cracks. Ozone and oxygen (o2) attack rubber goods much as steel rusts. Oxidation is characterized by a hard skin which eventually crazes in small cracks and may turn chalky or assume a bark like appearance.
The practice of first-in, first-out is essential with rubber goods.
Store rubber goods in a relaxed position in their normal shape; stretching or bending of rubber goods will result in accelerated aging or cracking. For example, do not hang O-Ring on pegs, glands, BOP testers or operator parts. Periodically inspect and treat with age resistant compounds the rubber goods that must be stored in a stretched attitude to detect aging signs.
Rubber goods storage areas should be kept as dry as possible. Remove oil, grease or other foreign materials from the storage area to preclude spillage on rubber goods. Rubber goods, both natural and synthetic, possess some degree of susceptibility to deterioration from carbons, which cause swelling/ shrinkage.
If storage for extended periods is anticipated, sealed containers are recommended. Impervious surface coverings such as waxing will increase shelf life.
Since the aging of a rubber product is dependent upon all of the above factors plus its size, specific composition and function, no precise figure is available for “storage life”. Generally, the greater the ratio of surface area to volume, the more susceptible a part is to being rendered useless by aging. For example, a relatively large part (by volume), such as a packing unit, might be expected to have a much longer useful shelf life that a thin-walled, large-diameter O-Ring.
No general rule can be drawn regarding usability. A large, heavy part might suffer the same total amount of aging as a small, light piece and still be usable. Thus, judgement becomes the rule and where there is doubt- replace the part.
Prior to using rubber goods that have been stored for periods of time, these checks should be made:
Is there “chalking” or “barking”?
Has the part developed a “hard skin”?
Do crack appear? (Sometimes cracks will be obvious; stretch or bend the part in question so that any incipient cracks or very thin cracks will be revealed.)
Will a suspect part pass a hardness test? (In the event that the hardness runs 15 points higher than the normal hardness of the part, it is considered non- usable.) Note: hardness is affected by temperature, and readings should be taken with the rubber part at 70◦ to 100◦ F.
6.3 PACKAGING OF PRODUCT
The materials/items for dispatch are packed in accordance to the type of materials/items, mode of delivery, weather condition etc. so that no damage or deterioration could occur during the transportation or handling.
Small items are suitably packed for the dispatch to ensure that no loss or damage occurs in transit.
The Storekeeper or Machine Shop Supervisor is to check the items prior packing in order to ensure that all items are packed as per packing list and as per requirements of the client, dispatch document and transport document.
Wherever special instructions related to packing and/ or transportation are given, are followed accordingly. Any change in this are considered as variation and are discussed and accepted between the client and XXX.
In such cases it is the responsibility of concerned manager to identify, document and instruct the type and method of packing to the store personnel and the QC Engineer.
Products requiring special attention e.g. capped, plugged or sealed to prevent damage and invasion of contaminant like ring grooves, hub, flanged and studded connections etc. are covered with a protective cover sufficient to prevent damage during normal handling.
Machine shop Manager/ Operations Engineer review Contract requirements so that finished goods are packaged as per customer’s requirement, if mentioned.
Finished products are properly protected with plastic or wooden protectors (varies as per the nature of products) to avoid entering of foreign material and damage.
Product is packed in such a manner as to prevent damage while in storage and during shipment to the customer.
Packaging may include but is not limited to the use of boxes, foam, protective wrapping, appropriate labeling, wooden or plastic pallets, shrink-wrap, and bagging.
6.4 PRESERVATION OF PRODUCT
XXX is to take exceptional care and ensure that preservation of materials is the foremost in the minds of all employees. Consequently, with materials which are subject or prone to deleterious condition (material oxidisation – rusting), all exposed finished surfaces are coated with a suitable rust preventive coatings.
Any material recommended to store within a controlled condition (electrode, paint material, rubber gaskets etc) are maintained accordingly.
It is the responsibility of the store keeper to store and preserve the material in accordance to the manufacturer’s recommendation to avoid any deterioration.
In order to detect the deterioration, the condition of the product or item in stock are checked at least once in 6 months and the frequency of assessment is mentioned in the ML of Items Assessed.
In order to preserve material while in storage, the material is stored in such a manner to prevent product from coming in contact with, and being damaged by, material handling equipment or the environment.
Operations Engineer/Machine Shop Supervisor ensures the preservation of all material and finished goods, as required, at all stages of the operation.
Products are stocked and pulled away from inventory only by authorized and trained employees.
6.5 DELIVERY OF PRODUCT
Deliveries of products are arranged according to the contractual agreement (i.e. by XXX, Supplier or Customer).
Proper documentation is made for each deliver (Delivery note, shipping document etc.)
No products are delivered without inspection release by the QA/QC Department by completing the Final Inspection Report or by signing the Delivery documents. The products for delivery securely pack in accordance with the relevant clause of this procedure.
Store Keeper ensures that all Products are packed and shipped in accordance with customer requirements or standard industry practice.
Packaging is reviewed for conformance to customer requirements prior to closing the shipping box/container.
Requirements for documentation to accompany are reviewed prior to closing the shipping box/container.
Shipments are not made without all required documentation.
In-charge – Store ensures that Packing slips include the customer PO number, part number, quantity, and, if required, Batch numbers.
Material Controller and In-charge Production ensures that Products are shipped via shipping/transport services that are reliable and handle products in a manner, which does not cause nonconformance.
When necessary, specific shipping and handling instructions is communicated to the shipper/transporter for correct handling of the product.
Where contractually specified, this protection is extended to include delivery to destination.
To ensure that the supply chain activities for the product realization are conforming to specified requirements.
To ensure that the critical products, components or activities identified in product realization are treated accordingly in supply chain activities and are in conformance to product or customer specifications;
To do initial evaluation and selection of supply chain partners (suppliers, associated sub-suppliers or subcontractors) based on their ability to supply products, components or activities in accordance with XXX‘s requirements.
To ensure controls are in place for the entire supply chain activities based on the criticality of the product, components or activities.
To include criteria, scope, frequency, and methods for reassessment of supply chain partners.
To ensure a listing of approved supply chain partners are in place and maintained in accordance with the scope of their approvals.
2.0 SCOPE
This procedure is applicable to all the following systems and standards
API Spec Q1, 9th edition/ ISO2 9001: 2022
API Spec ……
API Spec ……
API Spec ……
API Spec …..
API Spec …..
3.0 RESPONSIBILITY
Head of supply chain /Manager
Management representative/ Lead QA/QC
All concerned process heads
4.0 INPUTS
Material Requisition (MR) or Request for Quote (RFQ)
Inventory Management System (IMS)
5.0 RESOURCES
Competent Personnel, Adequacy of infrastructure, Information Technology as needed, intellectual property or information as needed, Funds.
6.0 DESCRIPTION
Supply chain defines in XXX is the department handling “supplier and associated sub-supplier(s) required for the product realization” including purchase, logistics, materials control and subcontract activities.
All purchased products or activity conforms to the specified requirements.
All supply chain activities will be documented, records and are made available all the time (Material Requisition – MR, Request for Quotation – RFQ, Technical Delivery Conditions – TDC, Comparison Statement – CS, Purchase Order – PO, Subcontract Agreements – SA, Store Receipt Voucher – SRV, Store Issue Voucher – SIV, and Stock Register/Inventory List (System Generated).
The primary concerns of Purchasing are:
To maintain a consistency of quality material which permits efficient and effective operations
To get the most competitive rate and thus reduce the production cost to the minimum.
To maintain availability of material in time.
To develop and maintain good relationships with supply chain partners so that XXX will have a competitive edge with its competitors, satisfying customer and maintain good cash flow.
To develop and maintain optimum inventory stock and efficient inventory management system
To maintain good records and controls.
To provide input to design and development or operations for new development.
7.0 GENERAL PURCHASING PROCESS
Purchase of any products, components or activities are done in a systematic manner so that they are consistently conforming to the specific requirements of the intended application and customer satisfaction.
In order to meet the above requirement, the company identifies the product category (critical or no-critical), evaluate and select supply chain partners in accordance with the specific category of purchase, re-evaluate the suppliers based on risk and quality performance of supplier, ensure right sourcing in accordance with this procedure, confirm supply chain communication are documented adequately and described the product or activity to be purchased in line with the conformity to the final product or service requirement.
Upon receipt the product or activity they are verified for it conformance prior to the acceptance of the product or service.
7.1 PROCEDURE FOR SELECTION OF SUPPLY CHAIN PARTNERS
In order to have the consistency in obtaining product or service quality the purchase activity in XXX are categorized mainly in to two ‘Critical and Non-Critical’. Accordingly, an “Approved list of Supply Chain Partner” is also maintained for both Critical or non-critical categories.
In order to do this segregation a list of critical goods, service, products will be prepared and maintained
The selection of the supply chain partners are based on their ability to supply products, components or activities in accordance to the Quality Management System requirements.
The criteria for the selection of the supply chain partners are done based on:
Technical listing is acquired from the list that provided by the client, owner, legal entities, or other international journals including API Composite Catalogue.
7.1.2 Achieved Quality status
Achieved Quality status is the supplier/or service provider’s capability and quality of supply is assessed and confirmed by a third party or by the organization (Supplier Audit) through verification of their quality management system or product/service provided by the supplier to a known circle.
7.1.3 Reference and Historical Quality Data
Selection of supply chain partner based on their past performance in providing such services in the market that is verified and conformed either by the organization or through other reputed organization or references.
Retaining supply chain partners in the approved list based on their historical data available with the organization and their ability to consistently meet the requirements of XXX product/service quality, acceptance criteria and need of personnel qualifications as applicable.
7.2 INITIAL SUPPLIER EVALUATION
7.2.1 Critical Purchases
In order to do the evaluation, selection and re-evaluation of Supply Chain Partner in Critical Purchases XXX identified its critical supply chain activities, product and services as mentioned in the table -1 (See Annexure)
Prior to the incorporation of the critical suppliers to the approved list, they are to be evaluated using supplier evaluation form but specific to the product/service considering the following but not be limited to:
Verification that supplier’s quality system requirements needed for the supply or product/service (job specific)
Verification of the type and extend of controls applied by the supplier, internally and to their supply chain, in order to meet the organization’s requirements
Assessment of the supply chain partner to ensure its capability to meet Organization’s Purchasing requirements by doing one or more of the following:
Performing on site evaluation of relevant activities OR
Inspection verification of similar product or service manufactured by the supply chain partner and ensures they are conforming to the stated requirement.
When product or service limited by proprietary, legal, and/or contractual arrangements; they are to be verified in accordance with product specific requirement of the final product, requirements specified by the customer or other regulatory body and where applicable the design acceptance criteria of XXX or its customer.
7.2.2 Non Critical purchases
XXX for the purchase of non-critical products, components or activities that impact product realization or the final product, the criteria for the initial evaluation of external provider/suppliers as one or more of the following
Verification that the supply chain partner’s Quality Management System conforms to the quality system requirements specified for the supply chain partner by XXX; or
Assess supplier by suitable means to ensure that they are capable of meeting the requirements specified or intended by the product realization
By doing Assessment of the Product or component upon delivery, or activity upon completion. This may be done by the QA/QC personnel up on receipt of goods at XXX facility.
APPROVED LIST OF SUPPLY CHAIN PARTNERS
Upon completion of evaluation, XXX maintains the approved list of supply chain partner they are listed either in Master List of Critical Suppliers or Master List of Non-Critical Supplier as applicable.
All active supply chain partners shall be evaluated once in year using Supplier Evaluation Form. If any new supplier to be added shall be done initially by using the supplier inclusion form and shall be monitored for three consecutive supplies prior to the inclusion.
Any supplier whose performance found to be poor during evaluation shall be identified by ‘W’ – watch in Master List.
Continuous deterioration of quality of supply by any means in three consecutive evaluations shall be marked as ‘Q’ and shall be shifted to the Quarantined list.
If any supplier in the “Q” list to be used shall be done under surveillance with close monitoring of every product or service they provide. In such case they are to be marked ‘S’ in the quarantine list. After 5 consecutive successful supplies they may be shifted to the Master List again and then will be treated as a normal approved supplier.
Records of the result of all evaluation and any necessary actions arising from the evaluation shall be maintained.
7.4 SUPPLIER PERFORMANCE RATING AND RE-EVALUATION:
The performance the supplier/supply chain partner shall be rated for every lot he has supplied on the basis of following criteria
Quality – 70 %
Commercial – 30%
2. Quality of Supplies are further Rated as per following criteria
3.5 Quality in communication (response, actions and completion) – 5
(Scale: Excellent co-ordination – 5, Very Good – 4 marks, Good – 3 Marks, Average -2 marks, poor -1 marks, No –Coordination – Zero)
3. Commercial Rating is further divided into
3.1 Response to enquiry in time – 5
(Scale: Same day – 5, within two days – 4, between 2-4 days – 3, between 4-7 days – 2, between 7-10 days – 1, more than 10 days – 0)
3.2 Cost competitiveness – 5
(Scale: Average all competent – 5, Average all Expensive -0)
3.3 Payment terms/Credit – 5
(Scale: >90 days – 5, Between 60 -90 – 4, between 45-60 –3, between 30 & 45 – 2, up to 30 days -1, no credit – 0)
3.4 Flexibility in payments – 5
(Scale: > 45 days – 5, Between 30 -45 days – 4, between 15-30 days –3, between 07 to 15 days – 2, up to 7 days -1, no credit – 0)
3.5 Post Delivery activities -5
(Scale: Excellent Support – 5, Very Good – 4 , Good – 3 , Average –2 , Poor – 1 , No Support -0)
4. Supplier rating will be done by the team lead by head of supply chain and the team comprises of (Head of Supply Chain, Lead QA/QC or his designee, Chief Accountant or his/her designee, store, and production head or his designee)
5. The performance rating of suppliers will be recorded on a quarterly basis and at the end of the year will be analyzed and external provider/supplier will be rated as follows :
Sl NO
SCORE
GRADE
STATUS
REMARKS
> 90%
A
Best
Priority supplier – Appreciation
71% – 90%
B
Good
Monitor frequently the weak areas – Communicate to improve
61% – 70%
C
Vulnerable
Communicate & Re-evaluate before placing order and check result
50% – 60%
D
Weak
Quarantine (only if no other option – use with high alert) & Communicate
<50%
E
Poor
Remove from the list permanently
6. When supplier rating is falling shall be treated in accordance with 5.3 of this procedure and may be intimated to the supplier for their necessary corrective action.
7. Based on the risk analysis for every supplier on the product realization and impact on the products, the overall risk and impact of the risk will be determined by averaging the percentage and categorized as High (>50%), Medium (15%-50%) and Low (<15%). According to the result of the risk analysis, frequency of the re-evaluation will be defined as follows :
after every serious failures
If no failures :
High – 9 months or ordering whichever is longer (this may be increased based on good historical records);
Medium – Within 18 months;
Low – No re-evaluation
7.5 PROCEDURE FOR PURCHASE
Need for any material, item or service by any department furnish a Material Requisition Form (MR). In case the procurement is from a single source or the quotes are obtained in case of technical procurement – the originator shall attach the copy of the details along with the MR for preparing the PR.
The MR prepared by the user/store, reviewed by the concern Engineer/in-charge and approved by the Head of the department.
Incomplete or inaccurate requisitions may be returned or notified to the originator for completion or correction.
Before floating enquiry by Supply Chain, he/she shall ensure with Stores for in-house availability of the product.
After receipt of completed requisition and confirmation from the stores, enquiry is floated to the potential external provider/supplier’s for bidding and the external provider/supplier making the “best offer” is selected.
Although the “best offer” concept is generally associated with lowest price, this is not always the case. In addition to price, consideration is given to availability, quantity, quality and service.
A comparative statement shall be made considering all the facts and before placing the order the same is been approved by General Manager. Alternatively a PO may also be made for the most competitive offer and submitted to the GM for his approval along with the comparison.
Purchase Orders shall be clearly described with the purchasing information as needed or applicable. Where it is found to be necessary a Technical Delivery Conditions (TDC) prepared and issued by the design or quality may be attached with the PO with a clear reference in the PO.
Information in the purchase document shall include as applicable:
Proper specification, including name, part number, type, class, grade, size, etc.
Technical details like relevant standards, specifications, drawings, process requirements, Traceability & other Technical data as required.
Other details like delivery place, delivery schedule, inspection requirements, packing requirements, etc.
7.6 PURCHASING INFORMATION
XXX ensures the adequacy of specified purchasing information prior to their communication to the supply chain partners.
Purchasing information provided to the supply chain partner is documented and adequately describe the product or activity to be purchased, including acceptance criteria, and where appropriate:
Requirements for approval of supplier’s procedures, process, and equipment;
Applicable version of specifications may include or be derived from the customer, API product specifications, design output and/or industry standards, process requirements, inspection instructions, traceability, and other relevant technical data;
Requirements for qualification of supplier’s personnel; and
Inspection and test requirement including XXX or it’s customer verification at supplier’s location including Hold or Witness points if any.
Verification or validation activities that the organization, or its consumer, intends to perform at the supplier’s premises.
Quality management system requirements.
7.7 VERIFICATION OF PURCHASED PRODUCT AT SUPPLIER PREMISES
Where there is a need of verification of purchased product at the supplier premises by the company or it’s client prior to the release of good from supplier premises, shall be stated clearly in the purchase document in detail such as verification arrangements, method of product release, arrangements needed for verification activity that has to be provided by the supplier.
Although the product verified by the company or it’s customer at supplier premises, the product is subject to incoming inspection upon arrival prior to the release of item(s) to it’s next activity.
7.8 EMERGENCY PURCHASE
Emergency purchase is applicable for emergency situation such machine breakdown, emergency requirement by the client that needs to be handled by XXX, or other emergency situation which are not created deliberately or a result of poor planning.
All emergency purchase shall be approved by the General Manager/Chairman.
Product or service purchased on an emergency shall also be subjected to the same verification process as needed by the regular purchase process
7.9 CONTROL OF OUTSOURCED PROCESS
Based on the criticality of product, where documented procedures, qualification of personnel or equipment, calibration records, validation of process(es) or quality management system requirement is in need shall be stipulated in the purchase document and shall be verified and confirmed by XXX’s QA/QC.
XXX ensures that all the outsourced processes which are required validation, shall be done in accordance with the procedure L2 – 13, Validation of processes for Production and Servicing.
7.9.1 CALIBRATION
When calibration process is outsourced, prior to the confirmation of order to the supplier shall ensure:
The adequacy of facility for the calibration of equipment to the required standard and its traceability to the international measurement standards as applicable.
Quality Management System of the calibration laboratory and it’s confirmation of it’s accreditation or certification such as ISO 17025.
Technical expertise of the personnel working in calibration laboratory as well as the calibration validity and traceability of their master equipment.
Calibration documentation with it’s measurement uncertainty for the master equipment
Assurance to quality and reliability.
7.9.2 LABORATORY ANALYSIS – CHEMICAL, MECHANICAL, ELECTRICAL, OR INSTRUMENTATION
When laboratory analysis is outsourced, prior to the confirmation of order to the supplier shall ensure:
The adequacy of facility for the analysis to be performed including equipment, environment, and other as needed for the required service.
Quality Management System of the calibration laboratory and it’s confirmation of it’s accreditation or certification such as ISO 17025.
Technical expertise of the personnel working in calibration laboratory as well as the calibration validity and traceability of their master equipment.
When NDE process is outsourced, prior to the confirmation of order to the supplier shall ensure:
An approved procedure verified by the NDE Level III is available.
Equipment for NDE is appropriate to the application and where applicable are calibrated.
NDE personnel are qualified and certified NDE Level II in accordance with SNT-TC-1A, where found necessary the qualification of NDE personnel shall be reviewed by company appointed Level III.
Ensure reporting is done in accordance with the relevant standard requirement.
Acceptance criteria of NDE shall be communicated to the NDE contractor.
7.9.4 PWHT
When PWHT process is outsourced, prior to the confirmation of order to the supplier shall ensure:
The equipment is adequate and calibrated to perform PWHT
Qualified personnel are performing the PWHT activities
PWHT procedure approved by XXX is available for doing PWHT
Attachment of thermocouples to the job and its placement are communicated for every job and ensures it is done accordingly.
Acceptance criteria for calibration, placing of thermocouple, rate of heating, rate of cooling, soaking time and other critical information are in place and available for the operator/supplier
7.9.5 PROTECTIVE COATING
When and protective coating process is outsourced, prior to the confirmation of order to the supplier shall ensure:
The process is validated and parameters to be followed are developed and documented in the form of procedure and available for the supply chain partner.
Environment suitable for the application shall be defined and are communicated either by approving the supply chain partner’s procedure or a procedure to be issued by XXX to the supply chain partner.
If validation of the process to be done by the supply chain partner for any reason shall be communicated and necessary action shall be taken accordingly.
Trained and experienced personnel shall be performing the protective coating.
When procedure from the supply chain partner is used, shall be reviewed and approved by XXX QA/QC prior to the use.
When hold or witness point is not there by XXX during the blasting or coating application, proper control measures from the supply chain partner assuring they adhere to the suitable environment condition.
Supply chain partner shall have suitable inspection and test equipment for the verification as needed and it shall be verified and confirmed by the XXX QA/QC.
8.0 OUTPUT
Purchase orders to external providers
Products & services procured
Supplier evaluation/rating
9.1 KEY PERFORMANCE INDICATOR
9.1 As per the Annual Objectives
10.0 ASSOCIATED DOCUMENTS & RECORDS
DESCRIPTION OF THE RECORD
FORMAT NUMBER
RESPONSIBLE
Master List of Critical External provider/suppliers
XXX / PRO / D01
Procurement Engineer
Master List of Non-Critical External provider/suppliers
To make a Plan needed to address risk associated with impact on delivery and quality of product.
To prepare and document contingency planning based on the output of the risk assessment made and communicated to all the relevant personnel.
2.0 SCOPE
This procedure is applicable to all the following established systems and standards
API Spec Q1, 9th edition/ ISO 29001: 2020
Related API Monogram Standards (…………..)
Applies to all process which has an influence on product quality and delivery.
Contingency Plan addresses, risk associated with impact on delivery and quality of product.
This procedure is applicable to all the levels of documents pertaining to API Spec Q1: 9th edition.
This procedure applies to the following Quality Management System processes:
Design
Purchase
Production
Quality Control
Stores
Maintenance
Human Resources
Management Representative
Commercial
3.0 RESPONSIBILITY
Chairman
Management Representative
All Process owners
4.0 INPUTS
Risk assessment output
5.0 RESOURCES
Manpower
Funds
6.0 DESCRIPTION
Contingency planning: An emergency plan prepared to address the significant risk activity generated from risk assessment that impacts delivery and quality of product. This includes the action plan derived to reduce the impact by executing alternate plan with responsibility / authorities with required internal & external communication.
Further the contingency plan works based on the risk criteria associated with Men, Machine, Method, Material and Environment.
7.0 PROCEDURE:
XXX maintains a documented procedure for contingency planning to address the risk associated with impact on delivery and quality of product
Contingency planning process:
Contingency planning is derived based on the Risk assessment performed by all the process functions. The significant risk associated with each process are segregated based on the below 5 categories,
Men: Human resources is one of the important and mandatory requirement for product realization which includes workmen, staff and managers
Machine: A machine is an important resource to meet the required product realization and possible risk like breakdown / out of tolerance is considered in preparing the contingency planning.
Method: Risk related to material handling and preservation of the product is considered in method.
Material: Risk related to material rejection, delayed shipment from the supplier, raw material shortage are considered for developing the contingency planning.
Environment: Risk related to natural disaster and their impact on quality or delivery of the product with required communication is considered.
Actions required in response to significant risk:
In XXX action plan for all the significant risk are derived and the different scenarios are considered to mitigate the effects of disruptive incidents. The details are summarized in Level – 04 contingency plan for significant risk
Identification and assignment of responsibilities and authorities:
In XXX for each significant risk, the responsible person is identified and necessary actions are derived with specified time limit. The details are summarized in Level – 04 contingency plans for significant risk.
Prepare communication matrix for different scenarios with relevant personnel’s:
Communication matrix for the prepared contingency plan is derived based on two categories, Internal and external.
Internal:
The responsible process head to execute the required contingency plan with required supports from other processes are considered. Further communication to top management is made mandatory for all actions
External:
Communication required for those suppliers, choose to perform the required activity as an alternate source.
Customer need to be intimated on the contingency plan taken to meet the product delivery and quality when there is risk which requires considerable time for normal flow.
The details are summarized in Level – 04 contingency planning for significant risk on development of the contingency planning the same need to be communicated for all the applicable personnel for inciting the actions
The actions plans need to be monitored periodically to ensure the objective is met.
Develop the contingency plan for the scenarios utilizing the available resources
While developing contingency plan all the resources available in the XXX to make the maximum utilization and then only external suppliers are considered.
Management approval:
If there is any need for new resource then, the same need to be taken for management approval
Criteria for revision of contingency plan
The contingency plan needs to be revised when,
There is new risk identified during production review meeting
When there is a major rejection
In situations / events where there is a risk of impact for delivery and product quality.
