Author: Pretesh Biswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .

Example of procedure for preservation of product

1.0 PURPOSE

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.

7.0 OUTPUT

Updated stock in the System
Monthly/Quarterly/Half-yearly assessment
Timely Delivery of finished products to customer

8.0 KEY PERFORMANCE INDICATOR:

Periodic stock assessment
Updated stock

9.0 ASOCIATED DOCUMENTS & RECORDS

DESCRIPTION OF THE RECORD	FORMAT NUMBER	RESPONSIBILITY
ML of Shelf life items	XXX / STR / D 01	Store Keeper
ML of Lubricants	XXX / STR / D 02	Store Keeper
ML of Chemicals	XXX / STR / D 03	Store Keeper
ML of Consumables	XXX / STR / D 04	Store Keeper
ML of Items assessed	XXX / STR / D 05	Store Keeper
Store Receipt Voucher	XXX / STR / 01	Store Keeper
Material Requisition	XXX / STR / 02	Store Keeper
Delivery Note	XXX / STR / 03	Store Keeper
Material Receiving Inspection Report	XXX / STR / 04	Store Keeper
Welding Consumable Withdrawal Slip	XXX / STR / 06	Store Keeper
Consumables/Tools Issue Record	XXX / STR / 07	Store Keeper
Consumables/Tools Return Record	XXX / STR / 08	Store Keeper
Material Receiving & Withdrawal Register	XXX / STR / 09	Store Keeper
Equipment In-Register	XXX / STR / 10	Store Keeper
Equipment Out-Register	XXX / STR / 11	Store Keeper
Store Assessment Form	XXX / STR / 12	Store Keeper
Personal Protective Equipment Issue Record	XXX / STR / 13	Store Keeper

Example for procedure of Customers / External Providers’ Property

1.0 PURPOSE

To document the methodology followed at XXX for identification, verification, safeguarding, preservation, maintenance and control of Customer / External providers’ property.

The procedure includes requirements for reporting to the customer/external provider any loss, damage, or unsuitability for use of customer supplied property. The intent of this procedure is to provide guidance and determine responsibility for the management of customer / external providers’ product.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

ISO 9001: 2015/ 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 every department and every person who comes into contact with customer/external providers’ product.

3.0 RESPONSIBILITY

Management representative/ Design & QA Manager
All concerned process heads.
All concerned personnel

4.0 INPUT:

Customer property, external provider property

5.0 RESOURCES:

Competent Manpower, Tagging, Departmental procedures.

6.0 PROCEDURE

Customer / External providers’ products are understood by XXX are the property or assets owned by customers or other interested parties supplied to XXX as “Free Issue Supplies” under the control of XXX. Such properties or products includes but not be limited to:
ingredients or components supplied for inclusion in product,
product supplied for repair, maintenance, remanufacturing or upgrading,
packaging material supplied by the customer
customer materials received for storage or preservation
Services supplied on behalf of the customer, such as transport of customer property to a third party, and
Customer intellectual property, including specifications, drawings and proprietary information.
All customer supplied materials are subject to the same inspection and verification in accordance with the L2 – 09 Control of externally provided products/services.
No such properties are received from the External providers.

6.1 IDENTIFICATION VERIFICATION AND INSPECTION OF CUSTOMER MATERIAL

Upon receipt of customer / external providers’ material, the store keeper verifies the same with the customer / external providers’ documents (delivery details, shipment note, or other relevant documentation) and if found, the material conforming to the customer document is recorded in the Store Receipt Voucher.
All customer/external providers’ material are identified with SRV No/Job No and the SRV should clearly state that the item is customer/external provider supplied and if the material is received for any particular job/contract the SRV should have the Job/Contract No for identification.
All customer/external providers’ materials are subjected to Q.C. Inspection and it is the responsibility of Storekeeper to inform the Q.C. Engineer for any such inspection.
All such material are properly identified and provided with adequate storage facility in order to prevent them from loss or the risk of damage.
In order to have the same control on the customer/external providers’ material (free issue material) similar to the purchased material, the free issue items are booked in to the store receipt system through SRV as mentioned above. The SRV identifies the Description of Material, Quantity supplied, Customer Name, Works Order Number and the inspection status.
The Q.C. Engineer inspects the item visually and physically in order to confirm that there are no physical damage, lost parts/items or any physical changes.
After the Q.C. verification or the verification by the store personnel (e.g. Storekeeper) if any material found not conforming to the requirement (Non-conforming material) the store personnel then distinguish between non-conforming products and conforming ones and inform to the Concerned Manager/ Superintendent who in turn informs the relevant customer in writing with the attached inspection report/picture of the damaged or defective material.
All non-conforming material (customer/external providers’ material) should also have the NCR filled same like any other nonconforming material.
Heavy materials are received at the same location where the material is to be stored and inspected at the same location. Rejected materials are identified and segregated immediately.
As described above all customer/external providers’ material received by XXX for any product manufacturing, project execution or services the manager or the superintendent responsible for that particular project is responsible for the control of customer/external providers’ product liaise with the concerned department (Design, QA/QC, Stores, Workshop etc.) within XXX.
Operating equipment/item are checked operationally at the time of receipt and delivery. This is not applicable for item received from the customer for repair. In any case the functional test is performed only after confirmation of the visual and physical inspection.

6.2 HANDLING OF CUSTOMER/EXTERNAL PROVIDERS’ INTELECTUAL PROPERTY

All drawings or other intellectual products supplied by the customer/external providers are controlled by the QA/QC Engineer or the Sevice center Manager, in case of projects/contracts.
All OEM (Original Equipment Manufacture’s) documents are issued to the company for any licensed work to be routed through the QA/QC department and the QA/QC department controls such document.
The QA/QC Engineer or the Sevice center Manager, upon receipt of any intellectual product from the customer, are logged in the Customer/Suppliers’ Property Record or the Job/Contract file and issue the same to the concerned department/personnel through Document Transmittal or written memo. For any revision or cancellation of such document the Commercial Officer/ QA/QC Engineer or the Sevice center Manager record the same in the log/file and issue the same to the original copy holder. If the document needs to be returned to the customer, it is collected from the copy holders and provided to the customer. Such instructions are clearly mentioned in the document transmittal/memo.
Where ever possible only the reproduced copies are issued to the production crew (working crew) to avoid any possible deterioration of the original document. When such copies are issued it is the responsibility of the concerned manager/superintendent to control such copies to avoid any possible misuse or control of any revision if applicable and the concerned manager/superintendent is responsible for safeguarding the customer/external providers’ documentation/ or product within their custody.
Upon completion of work all customer/external providers’ property received are returned to the customer/external provider or disposed as directed and to be mentioned in the Customer/Suppliers’ Property Record. It is the responsibility of the QA/QC Engineer/Commercial Officer or the concerned Manager/ Superintendent to maintain the confidentiality of any such documentation which is customer/external providers’ property and are not to be disclosed.
It is the responsibility of XXX to safeguard the customer representative (inspection personnel, technical advisor/specialists, supervisor or TPI) those who deployed to XXX from customer in order look after or assisting their work.
In case XXX is providing any service on behalf of customer (transport to a third party, loading or unloading of material, carrying out of any job to a third party on behalf of customer etc.) it is the responsibility of XXX to carry out the job with all necessary precautions and to the satisfaction of the end user. The concerned manager or the supervisor is responsible to carry out the same as mentioned above.

6.3 STORAGE, MAINTENANCE AND CONTROL OF CUSTOMER/EXTERNAL PROVIDERS’ PROPERTY

The Customer/External providers’ properties are identified as per 4.1 of this procedure and are stored in a designated storage area until it is taken up for the project/use.
Storage condition are adequate and suitable for the product/material and are verified and maintained accordingly. The Q.C. Engineer verifies such requirements during his routine check. In case storage of any such material found unsatisfactory, the Q.C. Engineer makes NCR and inform to the concerned department manager/superintendent or the store personnel for necessary corrective action.
It is the responsibility of the Storekeeper and the Sevice center Manager to conform there are NO UNAUTHORIZED USE OF CUSTOMER/EXTERNAL PROVIDERS’ PROPERTY.
Any periodic or routine maintenance required for the customer product, while it is with XXX custody is done by XXX or it is co-ordinated with the customer according to the terms and conditions of the contract.
Customer material received for any rectification, repair or re-manufacturing are also considered as customer supplied material and are treated accordingly. In such cases the request from the customer or the non-conformance reported by the customer are verified and any discrepancy are brought to the customer knowledge.
Customer/External providers’ product that is damaged, lost or, unsuitable for use of tagged, segregated and are recorded. Quality Department notifies the customer regarding the same.
Customer/external providers’ owned tooling & gauges are marked permanently, so that ownership is visibly apparent.
Safeguarding and maintenance of the Customer Equipment/Product are to be taken care by the Operations personnel.
The storage and maintenance of customer/external providers’ property is maintained by stores personnel and periodic assessment of stock is maintained.
If drawings are received from the customer, first the details of the drawings, customer name, and file number are entered in the Customer/Suppliers Property Record maintained by document controller, and then the drawings are filed in a manner to identify them easily.

7.0 OUTPUT:

SRV Number

8.0 KEY PERFORMANCE INDICATOR:

All customer & external provider property identified & protected

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Store Receipt Voucher	XXX / STR / 01	Store Keeper
Customer/Supplier Property Record	XXX / PRD / 07	Store Keeper

Example for procedure for Product Inspection/Test Status

1.0 PURPOSE

The purpose of the procedure is

To identify the product inspection and/or test status throughout the product realization process that indicates the conformity or nonconformity of product with respect to inspections and / or tests performed.
To ensure that only product that meets requirements or that is authorized under concession.

2.0 SCOPE

To document the methodology followed at XXX for product inspection and test status control

To ensure that the product has passed the required inspections and tests or authorized under concession is released.

This procedure is applicable to all the following systems and standards

ISO 9001: 2015/ 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

Management Representative
QA/QC Engineer
All concerned process heads

4.0 INPUTS

Production & Quality plan, Inspection & test plan, XXX procedures

5.0 RESOURCES

Consumables for testing, Equipments, M&M Resources
XXX Procedures/Work instructions, Competent Manpower

6.0 PROCEDURE

All materials within XXX have an identification based on the type (purchased/stock material, customer supplied material or in process/finished product).
All purchased material or stock material are identified by MRIR.
Customer supplied material are identified by SRV Number with customer identification
Material in process or finished product, are identified by Order number.
Inspection status of the Purchased items are as follows:
All accepted material are identified by Accepted Green sticker, Round green sticker on the material identification card, or GREEN paint at the end with SRV No (raw material bar stock) since it is stored outside.
Non-conforming material identified by Non-conforming Yellow Sticker or round yellow sticker on the material identification card. If possible item may be segregated to quarantine area.
Rejected/scrap material identified by RED Rejected Sticker or round red sticker on the material identification card or shifting to the scrap/non-conforming area.
Where sticker or label is not feasible it is replaced with paint marking with the same colour. Status indication, for in process inspection are in accordance with this procedure.
Inspection status of the Products/Equipment those are received for servicing are identified through Production & Quality Plan.
While identifying the product or parts by means of permanent identification, (Hard Punching) it is as per the requirements of the respective code or standard and such requirements are clearly identified in the Route Sheet/ Work Instruction/or other related document issued for the control of that operation.
However, some customers may require other methods or systems for identification. This has to be cleared out with the particular customer before implementing such a documented contract. Such contracts have instructions to carry out in order to make sure that all relevant products are processed under controlled manner as specified in the contract document (e.g. identification of rotary shoulder/casing and tubing connection by colour band identification, steel band on individual units etc.)
If a general colour coding system acceptable to the client is applied, such are displayed in a location, where the process is employed.
When material issued on an urgent basis prior to inspection and test are identified with an orange sticker on the material Identification card with a statement “Positive Recall” or with an orange positive recall card, so that if in case of nonconformity can recall the item immediately.
In case such material (refer point 11) is required to be cut in to more than one piece each part of that material is to have the same identification or a suitable traceability sheet is prepared to identify the same.

6.1 IN-PROCESS INSPECTION AND TESTING

Applicable 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 the this 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 to perform the final acceptance inspection at planned stages of the product realization process.
In project/site operations, the above may replace with a “Completion Report”

6.3 NON CONFORMING MATERIAL

Any material or product not conforming to the product specific requirement or manufacturing acceptance criteria are treated as non-conforming material in accordance with this Procedure
All non-conforming materials are identified in accordance with the L2 – 22 and are recorded in the NCR.
Products which have been rejected and have failed to meet the specification are rejected from the contract and are downgraded for repair or replacement of the part which has failed. Full test requirements are re-instituted until the unit meets the specification.

6.4 INSPECTION RECORDS

Inspection records are maintained to reflect the status of the product at all stages which include:-
Records of Incoming Material (MRIR & Store Receipt Voucher)
Records of In-process Inspection (Production & Quality Plan, Release Notes)
Records of Final Inspection (Work Shop Report, Dimensional Inspection 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 Record control

6.5 RELEASED BY QA/QC

The QA/QC Engineer fulfils the function of the ‘Company Inspector’ and is responsible for all inspection and testing operations undertaken by Specialist Oilfield Services. He has final responsibility for ensuring verification of conformance to the Contract Specification.
The QA/QC Engineer has the authority for the release of completed products from Specialist Oilfield Services to the customer.
XXX ensures that the product has passed the required inspections and tests or authorized under concession is released.
The QA/QC Engineer is authorized to sign all the documents and records for the final acceptance of the product, release of the product and approve the records of the product.

7.0 OUTPUT

Completed Production & Quality Plan, Work shop Report, All inspection reports, Release note, Delivery note

8.0 KEY PERFORMANCE

All product inspection & testing as per plan

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Production & Quality Plan	XXX / QA / 01	QA/QC Engineer
Store Receipt Voucher	XXX / STR / 01	Store Keeper
Material Receiving Inspection Report	XXX / STR / 04	Store Keeper

Example of Procedure for Identification & Traceability

1.0 PURPOSE

The purpose of the procedure is

To identify and trace while the product is under control of XXX, and / or the applicable product specifications throughout the product realization process, including applicable delivery and post-delivery activities.
To include requirements for maintenance or replacement of identification and /or traceability marks.

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
Machine Shop Manager
Operations Engineer
QA/QC Engineer
All concerned personnel

4.0 INPUTS

In coming products/services
Job orders
Customer/External provider
Product status
Tools, Equipment, M&ME

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, Stationaries, XXX Procedures

6.0 PROCEDURE

6.1 PRODUCT IDENTIFICATION

The name of products, their part numbers when available, label, location, type, model, and serial number and other related information, are some identifiable information for identification; all parts and assemblies that form part of a customer contract are identified by a unique Job/Heat/Part Number/API – Control Number or other approved code marking system.
Colored labels, stickers or paint may be used for the identification for the status of a particular product.
This identification method is maintained throughout all stages of the operation to enable traceability to the original requirements. This procedure is prepared to demonstrate the above activity.
SRV number identifies all incoming material and the status of inspection identified
Item or part during process identified by Job/Contract No
All customer supplied material identified with SRV No and customer name. Customer material for a particular job/contract, the job/contract number written on the material or the SRV should direct to the (identify) the particular job or contract number. (Refer Store Receipt Voucher – XXX/STR/01)
If any material is required to be cut into many pieces, each piece have the same identification or traceability sheet prepared to identify the same.
Service and Maintenance activities are recorded in Service Report or by equivalent reports that may be supplied by customers with Job/ Contract number references.
In summary all products and/ or parts available positively identified as conforming products before reaching the customer.
All concerned Department Managers are responsible to ensure that this requirement of product identification is carried out for easy traceability of products when non-conformance occurs and when customer complains about the delivered product.
Receiving, inspection and Store operation exist to reconcile material identification and receipt documentation for acceptability during receipt inspection through all production until final delivery of the completed products.
If any material found non-conforming to the requirement, the QC Engineer prepares a non-conformance report and the material is identified separately as non-conforming material.
In case of urgent release material for production prior to the inspection identified clearly POSITIVE RECALL.

6.2 INDIVIDUAL PRODUCT TRACEABILITY

Specialist Oilfield Services recognize the importance of both material and individual traceability and controls have been established throughout all Company Operations.
All Parts and Assemblies which form parts of a Customer Contract are identified by a unique Job/Contract/Part Number/SRV No.
This identification method is maintained throughout all stages of the Contract to enable traceability to the original requirements.
The Quality Assurance Department, the workshop operations or both maintain Procedures for identifying the Product from Company or Customer applicable Drawings, Specifications and/or other Technical Documents during all stages of Production, Delivery and/or Installation.
Receiving, Inspection and Stores Operations exist to reconcile material identification and receipt documentation for acceptability upon receipt to sight or during receipt inspection.
Where job lots are used, lot or batch control methods may be used but marking materials and methods must not be harmful to the parent material.
Processing of all contract parts is carried out in a controlled sequence and manner, as specified in the Contract Instruction Documents.

6.3 RECEIVING RAW MATERIAL FROM EXTERNAL PROVIDER

All material received from the external provider checked against the delivery note, purchase order and material certificates to insure that quantities ordered are correct and all material certificates are accounted for and signed off.
After all paperwork is in order and the material is unloaded, each piece of raw material checked to ensure that it is marked with the heat number from the material certificate for that piece of material. An indelible weather resistant marker used.
Items that are already marked should be checked against the certificate for accuracy.
When unloading the raw material and marking the MRIR numbers on the material is complete, all paperwork (copies of packing list, material certificates etc.) is inspected by the QC Engineer/Inspector, the MRIR signed off by the QC Engineer for inspection record.

6.4 MATERIAL PREPARATION

Before any material is cut for a work order in fabrication for a work order all prints, bills of material, routers and material traceability forms should be accounted for.
All raw materials should be marked with the MRIR number, MRIR with item number or MRIR with heat number. The MRIR have the complete identification of material for traceability.
All operations personnel are responsible to maintain the identification and traceability at all time.

6.5 CONTROL WITHIN THE WORKSHOP

The Production and Quality Plan provide the means for ensuring that the original Contract file requirements are being met and that the base Contract/Order requirements are being achieved at all stages of production.
Where ever possible maximum information for the identification and traceability recorded on the Quality Plan.
Depends on the type of work a separate traceability sheet may be prepared and maintained.

6.6 PRODUCTION HOLD

Within the manufacturing if any material to be hold for production due to any reason identified clearly with a Tag or the item may be transferred to the specific Hold Area.

6.7 SCRAP AND NON-CONFORMING

All non-conforming material identified by yellow sticker (Non-conforming) or yellow sticker on the material identification card, scrap or rejected item identified clearly with a red sticker (Rejected), red sticker on the Material Identification Card, Red Paint or segregated to the designated scrap/Non-conforming Material area.
The management of manufacturing and segregation areas is such that it precludes any possibility of production and/or residual stock retention intermixes.

7.0 IDENTIFICATION AND TRACEABILITY MAINTENANCE AND REPLACEMENT

All incoming materials in XXX are identified by MRIR No. /Heat No. / Part No. etc. When these material are taken for production the same identification maintained with the relevant unique identification (Job No/Contract No, Part No etc.) until the item changed as part or finished product.
Whenever the products are only identified by the Job No, Mfr’s serial number or the part number, the traceability of the material documented in a traceability chart/sheet, in the Quality Plan itself or such document which can provide the identification and traceability of the item.
The final product identification made and maintained in accordance with the product standard, drawing.
In case of customer supplied product received for repair, service or remanufacturing, the original identification considered as the product identification, which may be traceable through the internal marking system. This may be done through recording the mfrs. serial number on the SRV or on the Job inspection report as well as in the Production and Quality Plan and Delivery Note etc.
Operations Engineer/Supervisor along with QA/QC Engineer ensures that all the materials are properly identified during all stages of production process till the final product.

7.1 AT STORES

In stores the raw materials are identified by their codes/grades and placed at the designated places with proper tagging and identification.

7.2 MACHINES IDENTIFICATION

Identification of plant and machinery, office equipments, measuring instruments are identified by unique Identification number and records are maintained.

8.0 OUTPUTS

SRV Numbers, JOB number, Machine & MME Identification, Non-conforming products

9.0 KEY PERFORMANCE INDICATOR

Traceability

10.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Store Receipt Voucher	XXX/STR/01	Store Keeper
Delivery Note	XXX/STR/03	Store Keeper
Material Receiving Inspection Report	XXX/STR/04	Store Keeper
Production and Quality Plan	XXX/QA/01	Store Keeper

Example of Procedure for Validation Of Process For Production And Servicing

1.0 PURPOSE

The purpose of the procedure is

To validate processes for production where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use.
To demonstrate the ability of these processes to achieve planned results.
To maintain supplier conformance to these requirements
To define the method for controlling the performance of special processes.

It applies to all processes that have been designated as special processes.

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

QA/QC Engineer
Operations Engineer
Machine Shop Manager
All concerned personnel

4.0 INPUTS

Requirements for validation

5.0 RESOURCES

Competent Manpower, Requires equipments & MMEs
Standard specifications/requirements
XXX Procedures/Work Instructions

6.0 DESCRIPTION

To monitor the special processes to ensure controls are effective in their application.

The main concerns of Quality Assurance are:

To maintain a consistency of quality product/service
To inspect and test the product/service with proper calibrated instrument and gauges within the timeframe with respect to the overall objectives
To develop good relationship within the process in order to create an environment which enables XXX to discover new ideas
To achieve a high degree of cooperation and coordination with other departments and customers as well as third party inspectors
To maintain proper records and controls and assure efficiency and integrity
To ensure proper usage of allotted resources
To introduce standardization in requirements in order to simplify the specification
To be aware of secondary objectives which are supportive of other functions of XXX
XXX validates process for production and servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the servicing has been delivered.
Validation demonstrates the ability of these processes to achieve planned results. Where XXX chooses to outsource a process that requires validation, XXX requires that the supplier conform to these requirements.

IDENTIFICATION OF SPECIAL PROCESS

The processes are identified as special processes in XXX with following controls as mentioned in Annexure – A .

7.0 PROCEDURE

7.1 VALIDATION OF WELDING PROCESS:

7.1.1 WELDING PROCEDURE QUALIFICATION

In XXX, all Welding Procedure Specifications (WPS) and Procedure Qualification Record are prepared and Qualified in accordance with ASME Section IX. The detailed procedure is documented in Level III

7.1.2 WELDER QUALIFICATION

In XXX, welders are evaluated as per the documented procedure before allowing them to weld.

7.1.3 CONTROL OF WELDING CONSUMABLES

The procedure for Storage, Handling & Issue of welding electrodes is documented in the Level III.

7.1.4 BAKING OF LOW HYDROGEN ELECTRODES

Work Instruction explains the step by step procedure for baking of low hydrogen electrodes in the Oven.

7.1.5 CALIBRATION OF WELDING MACHINE

All welding rectifiers are calibrated once in every six months as per the approved Quality Internal Procedure.

7.1.6 CALIBRATION OF ELECTRODE BAKING OVEN

Electrode baking ovens are calibrated once in every six months as per the documented Quality Internal Procedure.

7.2 VALIDATION OF HEAT TREATMENT PROCESS

7.2.1 HEAT TREATMENT PROCEDURE

A documented Quality Internal procedure for post weld heat treatment is followed in XXX for performing heat treatment process.

7.2.2 CALIBRATION OF HEAT TREATMENT FURNACE

Heat Treatment furnace is calibrated once in a year as per the documented procedure.

7.3 NON DESTRUCTIVE TESTING

The following NDT processes are identified for validation in XXX:

Liquid Penetrant Test
Magnetic Particle Test

7.3.1 LIQUID PENETRANT TEST

XXX conducts the Liquid Penetrant Examination as per the documented procedure approved by a Level III certified NDT personnel.

7.3.2 MAGNETIC PARTICLE TEST

XXX conducts the Magnetic Particle Examination as per the documented procedure approved by a Level III certified NDT personnel.

8.0 SURFACE PREPARATION & PAINTING

A detailed documented procedure is followed to do the activities surface preparation and painting along with the safety precautions.

APPLICATOR QUALIFICATION PROCEDURE

Quality Internal Procedure describes the procedure for qualifying the personnel performing the blasting and coating processes.

QMS SPECIFIC REQUIREMENTS

XXX validates the processes for production where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use. Validation demonstrates the ability of these processes to achieve planned results. Where XXX chooses to outsource a process that requires validation, XXX validates that the supplier conform to these requirements

XXX maintains a documented procedure (L2 – 13: Validation of process) to address methods for review and approval of the processes including:

Required equipment;
Qualification of personnel;
Use of specific methods, including identified operating parameters;
Identification of acceptance criteria;
Requirements for records; and
Revalidation.

XXX validates those processes identified by the applicable product specification as requiring validation.

9.0 OUTPUTS

Validation records for each process.

10.0 KEY PERFORMANCE INDICATORS

No rejections

11.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Calibration of welding rectifier	QIP – 10	QA/QC Engineer
Calibration of electrode ovens	QIP – 11	QA/QC Engineer
Calibration of heat treatment furnace	QIP – 12	QA/QC Engineer
Control of Welding Consumables	QIP – 22	QA/QC Engineer
Surface Preparation & Painting	QIP – 31	QA/QC Engineer
Thermocouple welding procedure	QIP – 34	QA/QC Engineer
Post weld Heat Treatment procedure	QIP – 39	QA/QC Engineer
Welding Procedure Specification	QIP – 40	QA/QC Engineer
Magnetic Particle Examination	PRO / NDE / 04	QA/QC Engineer
Liquid Penetrant Examination	PRO / NDE / 05	QA/QC Engineer
Liquid Penetrant Test Report	XXX / QA / 05	QA/QC Engineer
Magnetic Particle Examination Report	XXX / QA / 06	QA/QC Engineer
Daily Blasting & Painting Report	XXX / QA / 08	QA/QC Engineer
Heat Treatment Inspection and Report	XXX / QA / 11	QA/QC Engineer
Welder Qualification Review	XXX / QA / 13	QA/QC Engineer
Welding Procedure Specification	XXX / QA / 31	QA/QC Engineer
Process Validation Record	XXX / QA / 39	QA/QC Engineer

Annexure – A

Process	Equipment	Personnel Qualification	Method	Acceptance Criteria	Records	Revalidation
Welding	Refer procedure QIP-40	Welder, Welding Inspector	As per WPS	Applicable Standards	WPS, PQR, WQT, Process Validation Record	Change in variables for procedures and performance & applicable standards
PWHT	Refer procedure QIP-39	PWHT Technician	As per WPS and PWHT Procedure	Applicable Standards	PWHT Record, Process Validation Record	Change in variables for procedures and performance & applicable standards
NDE	Refer Procedure PRO/NDE/04 & PRO/NDE/05	NDT LEVEL II Personnel	As per NDE Procedures	Applicable Standards	NDE Reports, Process Validation Record	Change in variables for procedures & applicable standards
Protective Coating	Refer procedure QIP-31	Blasting Operator, Painter & NACE Level II inspector	As per Product data sheets, blasting & Coating procedure	Applicable standards	Blasting & Coating Report, Process Validation record	Change in the coating cycle, coating material and applicable standards

Example of Procedure for control of Servicing

1.0 PURPOSE

To document the methodology followed at XXX to describe controls associated with the servicing of products. This is an important element of a QMS, which is the set of policies, procedures, and process used to ensure the requirements associated with the quality of a product are met.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

API Spec Q1, 9th edition/ ISO 29001: 2020
API Spec …
API Spec …..
API Spec …..
API Spec ….
API Spec …..

3.0 RESPONSIBILITY

Machine shop Manager
Operations Engineer
QA/QC Engineer
All concerned process heads

4.0 INPUTS

Production & Quality plan
Customer specifications/requirements
Standard specifications/requirements
Procedures/Work Instructions
Drawings

5.0 RESOURCES

Raw Material/Consumables
Equipments, M&M Resources
XXX Procedures/Work instructions
Competent Manpower

6.0 PROCEDURE

XXX maintains a documented procedure that describes controls associated with the servicing of products

Review and implementation of the XXX’s customer-specific, product servicing, and other servicing requirements. Such requirements will be mentioned in the Customer PO or confirmed by XXX and the details are mentioned in the contract review and Quotations.
The availability and use of suitable servicing, testing, monitoring, and measurement equipment (Refer Master list of Monitoring and Measuring equipment)
The availability of work instructions (Refer Master list of Work Instruction and Quality Internal Procedure (Refer Master list of QIPs)
Ensuring identification and traceability requirements are maintained throughout the servicing process;
The implementation of monitoring and measurement activities through Production and Quality Plan
Process control documents are maintained; and
Requirements for release of the product that was serviced are verified.

7.0 OUTPUTS

Completed Production & Quality plan
Final inspection reports
Finished product
Release note
Data Book/Documentation

8.0 KEY PERFORMANCE INDICATORS

Planned vs Actual completion- 100%
No rejections/reworks

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Master list of Products	XXX / PRD / D01	Machine shop Manager
Master List of Quality Internal Procedure	XXX / MR / D08	Management Representative
Master List of Work Instructions	XXX / MR / D11	Management Representative
Skill Competence matrix	XXX / HR / D02	HR Manager
Master list of M&M Equipment	XXX / QA / D02	QA/QC Engineer
Master list of Machines	XXX / MNT / D01	Machine shop Manager
Master list of Handling Equipment	XXX / MNT / D02	Machine shop Manager
Master list of Pumps	XXX / MNT / D04	Machine shop Manager
Master list of Test Stumps	XXX / MNT / D05	Machine shop Manager
Master list of Blind Flanges	XXX / MNT / D06	Machine shop Manager
Daily Work Control and Time Sheet	XXX / PRD / D02	Machine shop Manager
Weld Record Sheet	XXX / PRD / D03	Operations Engineer
Electrode Baking Details	XXX / PRD / D04	Operations Engineer
Production & Quality Plan	XXX / QA / 01	Machine shop Manager

Example of procedure for Verification of Purchased Products/Activities

1.0 PURPOSE

Purpose of this procedure is to ensure that the verification or other activities necessary for ensuring that purchased products, components or activities meet specified purchase requirements.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

API Spec Q1, 9th edition/ ISO 29001: 2020
API Spec …..
API Spec ……
API Spec ……
API Spec ……
API Spec …….

3.0 RESPONSIBILITY

Management Representative
QA/QC Engineer
Stores Keeper
All concerned process heads.

4.0 INPUT

Products/Services from external provider
SRV notes

5.0 RESOURCES

Resources needed for the receipt, handling, inspection, verification, storage, preservation, control, and documentation as appropriate for every product or service shall be available.

6.0 PROCEDURE

6.1 RECEIPT OF GOODS IN STORE

Upon issuance of purchase order a copy of the same shall be given to the Store Keeper, so that he can identify the material upon arrival and maintain proper identification and traceability of received goods.
Upon receipt of material/goods from the supplier, the store keeper (SK) shall verify the description, quantity and physical condition against the delivery document and tally the same both physical and document. If any discrepancy observed shall be noted and communicated to the Purchase Officer/Head of Supply Chain and subsequently to the QA/QC Engineer.
Upon confirmation of goods received are in line with an approved PO, the store keeper shall prepare a Material Receipt Inspection Report (MRIR) along with all other documents available such as PO, supplier delivery documents, relevant certifications (MTC, data sheet, batch certificates, etc.) and given to the QA/QC personnel for inspection and release.
QA/QC personnel verify the received product/material or components in line with the PO and confirms that the item received are meeting the requirements specified in the PO which including all technical delivery conditions.
Conformance of product quality will be marked as accepted in the MRIR (signing and stamping the MRIR) by the QA/QC Personnel.
When the Mill Certificate, Batch Certificate or Certificate of Conformance or other documentation deemed necessary to confirm the acceptance of product/service quality, they are to be requested and shall be reviewed prior to the acceptance of the product/service.
It is the responsibility of QA/QC Engineer who inspect or verify the material is using the applicable version of specification, drawing, process requirements, inspection instructions, traceability and other relevant technical data at the time of his inspection/verification.
After the QA/QC verification and acceptance of the purchased product, the store keeper prepares Store Receipt Voucher (SRV) and receive the material in store (inventory or job/contract) account.

6.2 IDENTIFICATION, TRACEABILITY AND INSPECTION STATUS

All the material good received in store shall have unique identification and traceability to its source, purchase, inspection, release, issuance and use.
In order to maintain this trace ability XXX identify all the received good with a SRV Number marked on the item or on the lot where individual marking is not practically possible.
SRV number is a unique identification number that starts with a new serial number at the beginning of every year and it continue in a sequential order till the end of that year. Every SRV will have the relevant PO number and that will trace the source and supply and the GRIR number that will indicate the verification, inspection and acceptance details.
In order to identify the different grades of bar stock, a colour coding chart is developed and displayed near the material storage area.

6.3 VERIFICATION OF STOCK MATERIAL

Critical product and components in stock shall be verified for it’s storage, preservation and ability to meet the intended results in product quality shall be verified by suitable means.
Based on the inspection findings the QA/QC Engineer or the Lead QA/QC may take decision on inspection and acceptance of such products in coordination with design engineer.

6.4 ISSUANCE OF STOCK MATERIAL

When any purchased product is in need for the production or operations, the concern person or department will raise a request to the store and the SK will issue the goods after verifying the intended purchase.
Product purchased for a particular project/job shall not be issued for any other job unless approved by the GM

7.0 OUTPUT

Reviewed MTCs/Reports/Certificates
Quality checking reports

8.0 KEY PERFORMANCE INDICATOR

Refer to Annual Objectives

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION OF THE RECORD	FORMAT NUMBER	RESPONSIBILITY
Purchase Order	XXX / PRO / 01	Procurement Engineer
Material Receiving Inspection Report	XXX / STR / 04	Store Keeper
Nonconforming Product Report	XXX / QA / 42	QA/QC Engineer
Store Receipt Voucher	XXX/STR/01	Store Keeper
Store Issue Record	Software	Store Keeper
Issue Record	XXX/STR/07	Store Keeper
Store Return Voucher	XXX/STR/08	Store Keeper

Example of procedure for control of supply chain management

1.0 PURPOSE

The purpose of this procedure is

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
- Achieved Quality status
- References and Historical Quality Data
- Initial Supplier Evaluation – Critical & Non-Critical
- Re-evaluation of supply chain partners

7.1.1 Technical Listing

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

2.1 Ability to meet the requirement specified – 5

(Scale: Fully meeting specification – 5 – Not meeting specification -0)

2.2 Product/Service Quality (Non-conforming product or service if any) – 5

(Scale: Rejection per lot 100 % Pass – 5, Rejection in whole lot of supply – 0)

2.3 On time delivery – 5

(Scale: On time delivery on all PO – 5, Delay in all deliveries – 0)

2.4 Quality Management System (Assessment based on performance) – 5

(Scale: 100% meeting QMS requirement – 5, Not meeting QMS Requirements -0)

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.
Assurance to quality and reliability.

7.9.3 NON-DESTRUCTIVE TESTING – RADIOGRAPHY / ULTRASONIC INSPECTION

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	XXX / PRO / D02	Procurement Engineer
Master list of outsourced services	XXX / PRO / D03	Procurement Engineer
Master List of Critical goods/products/services	XXX / PRO / D04	Procurement Engineer
Purchase Order	XXX / PRO / 01	Procurement Engineer
Comparison	XXX / PRO / 02	Procurement Engineer
Request for Quotation	XXX / PRO / 03	Procurement Engineer
Supplier Evaluation Form	XXX / PRO / 04	Procurement Engineer
Clearance Form	XXX / PRO / 05	Procurement Engineer
Vendor Rating	XXX / PRO / 06	Procurement Engineer
Supplier Registration	XXX / PRO / 07	Procurement Engineer
Vendor Appraisal Critical Suppliers	XXX / PRO / 08	Procurement Engineer
Supplier Audit Checklist	XXX / PRO / 10	Procurement Engineer

TABLE 1 – ANNEXURE

Product/Services	Criticality	Impact	Extent of Verification	Controls
Product/Services	Criticality	Impact	Extent of Verification	Internal	External
Welding	High	Product Quality	100%	Qualified Procedure	Qualified Personnel
Welding Consumables	High	Product Quality	100%	Receipt Inspection	Certificate of Conformity
NDE Personnel	High	Product Quality	100%	NDE Procedure	Personnel Qualification
NDE Consumables	High	Product Quality	100%	Receipt Inspection	Certificate of Conformity
Inspection Equipment/ Measuring Instruments	High	Product Quality	100%	Ordering information and Receipt Inspection	COC and Calibration Certificate
Inspection Personnel – TPI	High	Product Quality	100%	Selection	Qualification / Certification
Laboratory Analysis	High	Product Quality	100%	Selection	Qualification / Certification & Accreditation
Calibration	High	Product Quality	100%	Selection	Qualification / Certification & Accreditation
PWHT	High	Product Quality	100%	Procedure	Equipment and Operator Qualification
Protective Coating Material	High	Product Quality	100%	Receipt Inspection	Batch Certificate
Tools and Inserts	High	Product Quality	100%	Receipt Inspection	Reputation
Components or parts	High	Product Quality	100%	Receipt Inspection	Certificates
Raw material	High	Product Quality	100%	Receipt Inspection	Mill Certificate
Repair or maintenance	High	Equipment Performance	100%	Right Sourcing	Reputation/Qualification

Example of procedure for Contingency planning

1.0 PURPOSE

The purpose of this procedure is

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: 9^th 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.

8.0 OUTPUT

Contingency planning
Management of change

9.0 KEY PERFORMANCE INDICATOR

Contingency planning for significant risks

10.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Contingency Planning	XXX/MR/19	Management Representative

Example of Procedure for Design

1.0 PURPOSE

The purpose of the procedure is:

To identify the plans, including plan updates, used for design and development
To identify the design and development stages
To identify resources, responsibilities, authorities
To identify review, verification, and validation activities
To identify the requirements for the final review of design

2.0 SCOPE

This procedure applies to all the products which are designed by XXX. The primary concerns of Design & Development are:

To ensure that all the customer requirements are fulfilled
To plan the design process based on the available inputs within the given time frame
To ensure the design is made as per the Design Development Plan
To determine appropriate stages to review, validate and verify the design
To ensure that the corrections required in the later stages are incorporated in the design after the approval from the MR

This procedure is applicable to all the following systems and standards

API Spec Q1, 9th edition/ ISO 9001: 2020
API Spec ….
API Spec …..
API Spec …..
API Spec …..
API Spec …..

Applies to all process which has an influence on product quality and covers the Design and Development activities of all new products by the XXX

3.0 RESPONSIBILITY

Manager – Design & Development
Asst. Machine Shop Manager
Design Engineer
Operations Engineer
All concerned process Heads

4.0 PROCEDURE

Prior to any Design and Development the customer requirements are understood fully and clearly in respect to the product (use, code of construction/manufacturing standard, standard/code requirements, service requirements etc.). The end-result (products) of the design and development meets the satisfaction and expectation of customers in terms of its intended application and usage.

4.1 DESIGN & DEVELOPMENT – PLANNING

Based on the Ideas, Technical & Commercial Requirements from the Customer, Contract Review (if any), & Market Survey, the Product Identified for New Design & Development.
Collection of Product / Process details, Assumption, Customer Supplied Documents etc. (if any) for the Product Identified for New Design & Development.
A Cross Functional Team (CFT) composed of Team Leader (Manager – Design & Development), and Team Members like Asst. Machine Shop Manager, Design & Operations Engineer, Procurement Engineer, QA/QC Engineer and Commercial Officer at XXX plan and carry out the design and development of products.
Manager – Design & Development acts as the API Design Interface Manager responsible for review, verification and validation of API product. This can be substituted by the Quality Systems Manager, Asst. Machine Shop Manager or his designated Design Engineer or Operations Engineer.
The Duties and Responsibilities of the Design and development staff are centered on their academic and technical qualifications.
MR / QHSE Lead is identified as the competent individual(s) other than the person or persons who developed the design and shall approve the final design.

The Design and Development activities start during the following stages of the contract/order.

1. Upon receipt of contract

According to the contract technical requirements, where the design and development is under the responsibility of XXX, the Manager – Design & Development or his team/designated design engineers carry out the design activity.

2. During Manufacturing

In case XXX uses customer drawing or design for the manufacturing of the product or those found conflicting to the standard requirements or manufacturing process methodology, such documents are subjected to design verification and be done in conjunction with the customer or customer representative.
Manufacturing of all API products are subjected to design development prior to manufacturing.
It is mandatory that XXX should have all applicable API specifications related to the manufacturing of API product.
During the Design and Development Plan phase of the product, XXX determines:
- The design and development stages (as appropriate)
  - Collection & Preparation of Design inputs & Machine shop documents
  - Design Review
  - Procurement of Raw material / items
  - Machining & Inspection of Items (Verification)
  - Assembly & Testing (Validation)
- Design review is carried out in 3 Phases, using a structured Design Plan by a Cross functional team.
  - First Review – Part Report, Drawing & Specification Release
  - Second Review – Parts ready for Machining & Inspection after receipt of Raw material / items.
  - Third Review – After completion of Design Validation
The company’s Design and Development planning is based on the availability of resources, reference codes and standards and the qualification and training of personnel, who are directly involved in the design activity.
The Design & Development Plan contains sequence of activities, time estimation, responsibility & authority. The output is updated as appropriate, as the Design and Development progresses.
The responsibilities and authorities for Design and Development are defined in the appropriate section of the Product Design Package.
The interfaces between the different processes / groups of XXX are documented to ensure effective communication and clear assignment of their responsibilities.
XXX has established the following for Design and Development:
- A documented procedure for carrying out Design and Development
- Suitable resources in terms of:
  - A dedicated team for Design and Development
  - Necessary Infrastructure and Facility
  - Requisite Software
Design & development of API products as per the monogram and license requirements is carried out internally by XXX. Hence the question of outsourcing does not arise.
When design and development activities are performed at different locations within XXX, the procedure identifies the controls required to ensure that designs meet the requirements.

4.1.2 DESIGN ORGANIZATIONAL & TECHNICAL INTERFACES

Design and Development Planning ability relies on Technical and Non-Technical ability which has been defined within the company which is established to ensure that all inputs into the process are properly documented, transmitted as required and reviewed on a formal basis. The Design Department is aware that the Design function is fundamental to the creation of a quality product and consequently ensures that the Design function includes basic information concerning the parameters of:

Maximum functional requirements (API Acceptance Criteria)
- Maximum Environmental Expectation
- Cost Limitations
Design and development process is documented in the form of Design Packages and documented in hard, identified, follow controls.
Design documentation includes, methods, assumptions, formula and calculations.

4.2 DESIGN AND DEVELOPMENT INPUTS

Inputs are identified and reviewed for adequacy, completeness, and lack of conflict in Design Input record and these inputs include,

Requirements provided from external sources, including API product specifications
Customer specific requirements,
Environmental and operational conditions
Methodology, assumptions and formulae documentation
Historical performance and other information derived from previous similar designs
Legal requirements, and
Results from risk assessments.

Records of design inputs are maintained.

The design input requirements are ascertained by the Design CFT at XXX based on the internal inputs, documented market research, source of raw material, customer needs provided information. These inputs include,
- Safety, Functional & Performance Requirements
- Applicable statutory & regulatory requirements of the product
- As applicable, information derived from previous design
- And any other information, essential for the design and development
All ambiguous or conflicting requirements must be resolved before starting this input process.
Design input requirement is a specified requirements developed through the contract reviews. Ambiguous/Conflicting requirements observed during the implementations be resolved with those responsible for drawing them up.
These above inputs are reviewed by XXX CFT for adequacy, suitability, and effectiveness of result during the Design Review meetings and recorded.
XXX’s CFT ensures that the requirements stated in the Design input phase are complete, unambiguous and not in conflict with each other, as per the standard requirements
Design analysis / calculation performed & recorded when necessary.
XXX ensures that the design input requirements are identified, documented and review the product design input requirements.
The Design and development also includes Customer Specific Requirements.

4.3 DESIGN AND DEVELOPMENT OUTPUTS

Manufactured products are always being expected to meet the input requirements. The Manager – Design & Development who is normally the DND Team Leader who is appointed and authorized by the Top Management because of his academic and technical qualifications verifies these output products. He is directed to report to the Chairman and he has to always document his report on matters related to verification of the manufactured/ fabricated products.
The Manager – Design & Development ensures that he has full knowledge of the API design requirements on specific calculations whereon the design and development is centered on; and on the basis of this foundation, he continuously checks the adequacy and accuracy of the products under development from design stage to the final stage of development.
The DND Team pools together their resources to provide appropriate documented information about the finished product in terms of its production process, servicing provision after sales and to provide safety instruction on how to use the product for customer satisfaction.
When required, detail drawings are to be produced where API specs in design calculation are mentioned thereon.
The Design documents prepared with all necessary information regarding the procurement of raw material (Bill of Material with all the specifications requirements and Technical Delivery conditions), special requirements (E.g. 100% NDE, Hydrostatic test requirements, Pneumatic requirements, etc.) special process requirements (E.g. Heat treatment/ PWHT, Sand Blasting, Painting, Welding, Hard facing, etc.), Sales Service requirements (E.g. Recommended spare parts list, Service Requirements, etc.), acceptance criteria (Manufacturing Tolerance) and the characteristics of the product that are essential for its safe and proper use (E.g. Design pressure, Working pressure, Hydrostatic Test pressure, Maximum applicable load, etc.)
The outputs of Design and Development at XXX are prepared in a suitable form (Design documents / Records / Drawings / Technical Specifications) for verification against the design and development inputs.
Assembly / Component drawings, Bill of materials, Data base information’s and Material / Quality specifications are considered as a Design output – Product related
Process flow chart, Work instruction, Operational plan and Quality plans are considered as a Design output – Process related.
Before releasing the design output documents, the specific requirements as said in the design inputs are reviewed. The Design Outputs are approved by Manager – Design & Development along with MR/QHSE Lead prior to release
The Design and Development Outputs meet all the requirements identified and required as per the Design and Development inputs
Products that have failed to meet the specifications are rejected from the contract and are downgraded for repair or replacement of part, which caused the subject of non-conformance. Full test requirements are re-instituted to meet specifications.
The Design and Development Outputs provide appropriate information in the form of Drawings, Technical specifications and related documents, for Purchasing, Production process and other related Service functions.
The Design and Development Outputs contain or have reference to the Design acceptance criteria, in the form of Drawings, Technical Specifications, Engineering documents, etc.,
Specify those characteristics – special or critical in the product, which are essential for the proper and safe use. Example: Critical characteristics are mentioned in the drawings.
The information provided to Production and Service function includes the methods for preservation of the product like Handling, Storage, Packing, Preservation etc.
Design document databases secured to prevent unauthorized changes. Access to these databases is controlled by the engineering process. Engineering process provides copies upon the request.
Output includes results of applicable calculations and specifies the characteristic of the products that are essential for its safe and proper use.
The design and development Outputs are documented in the form of Part Reports (Data Base Information), Drawings, Technical Specifications, Bill of Materials etc.

4.4 DESIGN AND DEVELOPMENT REVIEW

Review meetings are conducted per plan with the Cross Functional Team & engineering process ensures the entire relevant document should be present.
Qualified and experienced personnel (other than those who initiated the original design) as designated by the management perform alternated calculation/ test programs reviewing, and checking. Review will be based on the API Standard design requirements and other related standards to the design work, and existing design documentation. This is done because all design works of XXX are carried out to pre-established API design specifications.
In general the Design and Development Review is carried out to evaluate the suitability, adequacy, and effectiveness of the results of design and development in four different stages to meet specified requirements.
- Design Input review
- Design Document Review
- Design Output review
- Review of design modification

4.4.1 DESIGN INPUT REVIEW

Prior to the Design and Development Process all design in-put requirements reviewed by the Design & Quality Systems. Manager or the Design Review Team to understand the product specific requirement based on the contract/customer requirement or the requirements of manufacturing standard (Construction Code). All statutory and regulatory requirements, functional and performance requirements also to be reviewed in view of Design output.

4.4.2 DESIGN DOCUMENT REVIEW

Design document review is carried out upon completion of design activity and prior to the issuance of design document for manufacturing. This review is to check whether the design input requirements are considered during design, incorporate any suggestions or recommendations from the Manufacturing personnel to carry-out the manufacturing process more economically and efficiently (e.g. Type of weld joint, type of connections etc.). All design documents including actual design calculations and drawing, type grade of material and its availability, technical delivery conditions are reviewed in this meeting and any adjustment or changes requirement is documented. It is the responsibility of Design Manager to do the follow-up for any such recommendations.

Participants for the Design Review include representatives of functions concerned with the design and development stage(s) being reviewed
In Design and Development review, the design out-put review is the essential function in order to verify and confirm the in-put requirements for the design and development are considered and are managed in order to confirm the design/product has the ability to meet the intended requirements and to identify if problem exists so appropriate corrective action can be implemented.

4.4.3 DESIGN OUTPUT REVIEW

Design Out-put review carries during product manufacturing or during proto-type manufacturing. In case of product for mass production, which is having complex design are proceed only after confirmation of its prototype.
All prototypes are subjected to 100% check in all aspects (which includes but not be limited to: – dimensional check, acceptance criteria, assembly, functional check etc.) prior to the mass production. This review is headed by the Machine shop Manager with advice from the Quality Systems Manager and with the support of the Operations & QA/QC Engineer and Machine shop Supervisor.
All information pertaining to the design and development of a product reviewed and confirm that the product meets the requirements as stated. All service information reviewed for its practicality and in case of any instructions for the safety of personnel or product also be reviewed for its accuracy.
Records of the results of the Design reviews and any necessary actions are maintained
The points discussed and the further necessary actions needed are recorded in the form of minutes of meeting with the responsible process / personnel.

4.4.4 REVIEW OF DESIGN MODIFICATION

All modifications or changes to the design are subjected to design review. Design Manager has the authority to review the changes in the design.

4.4.5 RELIABILITY ENGINEERING

Within XXX design, operation, reliability engineering is clearly defined as the finished product having the ability to perform within a stated code, standard or specification parameter, and consequently reliability engineering is performed by the Machine Shop manager commensurate with the product for a specific in-service purpose.
The Machine Shop Manager is responsible for reliability engineering activities and assigned as required these duties as appropriate to the workshop Superintendent.
In order to meet the design output (Product) to the design input requirements and to assure the product integrity the following controls employed and followed by this Quality Management System:
The Design Manager or his designated Design Engineer is responsible for the review of design in-put requirements in order to develop the right design in respect to the customer requirement.
The Design Manager, who is responsible for the design & development of the product, is responsible for verifying the product design at various stages.
Design and Development for any product carried out by the Design Engineer in accordance with the contractual technical specification (customer requirements) and the manufacturing specification. So it is vital that the Specialist Oilfield Services have all relevant specification/code (latest edition) for the Design and Manufacturing of product. It is the responsibility of the Quality Systems Manager to arrange all such codes and standards for design personnel.
- All design calculations and drawings including revision prepared and reviewed by the design engineer and approved by the Design Manager.
- General arrangement drawings and detailed drawings are prepared by the draftsmen, verified by the Design Engineer (DE) and approved by the Design Manager (DM).
- In case the design documents (drawing, design calculations) are supplied by the customer or subcontractor the same reviewed by the DE and approved by the DM.
- All design software output verified for compliance by the DE and approved by the DM prior to the issuance.
- The DE verifies the design software periodically for its compliance to the revised code/standard where applicable.
- It is the responsibility of DE or DM to issue the latest design document to the production/operations through Document Transmittal. It is the responsibility of the copy holder/user to discard the obsolete documents upon receipt of the revised one.
- Design and Development review carried-out in accordance with this procedure and the QMS Manual
- DND Verification, DND Validation and Control of Design and Development changes in accordance with this procedure and the Quality Manual.

4.4.6 DESIGN AND DEVELOPMENT REVIEW – SUPPLEMENTAL

Final review conducted & documented. Individuals other than the persons who developed the design approved the final design.
At XXX, Manager – Design & Development and Quality Systems Manager are authorized to approve the final design.

4.5 DESIGN AND DEVELOPMENT VERIFICATION

Design Verification at XXX, is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development output requirements
Records of the results of the verification and any necessary actions are recorded & maintained.
Design verification activities includes one or more of the following:
Confirming the accuracy of design results through the performance of alternative calculations; internally or through certified External agencies
Review of design output documents independent of the activities
Comparing new designs to similar proven designs.

4.5.1 DESIGN ACCEPTANCE CRITERIA

The Manager – Design & Development or Quality Systems Manager approves the Design acceptance criteria based on the under noted:

Product Specification and /or manufacturing instructions
- The degree to which functional requirements have been expressed within the design
- The degree to which the design permits rational production
- The efforts made to attain a reasonable life (or failure rate) with less maintenance
- Design verification activity

4.6 DESIGN AND DEVELOPMENT – VALIDATION

Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation is completed prior to the delivery or implementation of the product. This can be done by means of functional test, test specified in the manufacturing code, standards or field performance test. It is advisable to do such tests prior to the delivery of final product to the customer.Design Validation are carried out as per Design Validation Procedure (as per the product specification and standard)All the completed designs will be approved after the validation. MR approves the final design by reviewing the Certificate of Conformance (COC) and all inspection reports as necessary.Records of the results of validation and any necessary actions are maintained. Design validation includes one or more of the following:

Prototype tests
Functional and/or operational tests of production products;
Tests specified by industry standards and / or regulatory requirements;
Field performance tests and reviews.

4.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

If changes are required on the engineering documents, engineering team initiates to do a preliminary changes and Design & Quality Systems Manager reviews the same before release.
Identify changes noted thoroughly & sent to all processes / suppliers in the form of change alert.
Prepare Design Change Note (DCN) with detailing the DCN no., part details, revision level, nature of change, effect of change, detail of internals drawings revisions etc.
Forward the filled DCN to concerned processes (Stores / Planning etc.) for disposition actions of the existing stocks
After receiving the DCN with the above details, the same should be reviewed & approved by Design Manager with implementation date.
Records of the results of the review of changes and any necessary actions maintained.
In case of any difficult to implement the design changes, obtain waiver for the same & get approval from Customer
Update the revised data sets in server and the obsolete data sets are maintained in the separate folder for future reference. Databases secured to prevent unauthorized changes.
Any change that occur during process or after delivery of the product to the customer are identified & the changes are exercised through the review, verification and validation process, which includes the evaluation of the effect of the changes on constituent parts of the product & product already delivered
Design and development changes are identified and records maintained
At XXX, Design and development changes including changes to design documents, requires the same controls as the original design and development, and design documentation.

4.8 REGISTRATION, FILING, RELEASE AND DISTRIBUTION OF DESIGN AND DEVELOPMENT DOCUMENTS

Master Index of XXX for all API Design Activity is kept in the custody of the Design Manager in the Design & Development Department.
The records of all drawings are to be kept by one of the Design Engineers who is designated to do the job of custodian of the Drawing Register.

ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
ML of Drawings	XXX / DND / D01	Design Manager
ML of Design Packages	XXX / DND / D02	Design Manager
Responsibility of CFT	XXX / DND / 01	Design Manager
Cross Functional Team	XXX / DND / 02	Design Manager
Design & Development Plan	XXX / DND / 03	Design Manager
Design Input	XXX / DND / 04	Design Manager
Design Review	XXX / DND / 05	Design Manager
Design Output	XXX / DND / 06	Design Manager
Design Calculation Sheet	XXX / DND / 07	Design Manager
Design Verification Record	XXX / DND / 08	Design Manager
Design Validation Record	XXX / DND / 09	Design Manager
Transmittal Form	XXX / DND / 10	Design Manager
Document Progress Register Form	XXX / DND / 11	Design Manager
Design Change Note	XXX / DND / 12	Design Manager
Certificate of conformance	XXX / QA / 23	QA/QC Engineer