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

1. Manager – Design & Development
2. Asst. Machine Shop Manager
3. Design Engineer
4. Operations Engineer
5. 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,

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

Records of design inputs are maintained.

1. 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
2. All ambiguous or conflicting requirements must be resolved before starting this input process.
3. 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.
4. These above inputs are reviewed by XXX CFT for adequacy, suitability, and effectiveness of result during the Design Review meetings and recorded.
5. 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
6. Design analysis / calculation performed & recorded when necessary.
7. XXX ensures that the design input requirements are identified, documented and review the product design input requirements.
8. 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

1. Master Index of XXX for all API Design Activity is kept in the custody of the Design Manager in the Design & Development Department.
2. 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