Example of procedure for use of External documents in Product Realization

Uncategorized 2 Minutes

1.0 PURPOSE

To define the methodology followed by XXX for the regular change, updating, maintenance and control of External documents. The documented procedure includes:

  • Standards, Directive, and Customer Specifications.
  • External specification requirements, including addenda, errata, and updates are used in the design or manufacture of the product.
  • Integration of these requirements into the product realization and other affected processes.

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 INPUTS

  • Drawings, Specifications
  • Purchase Orders
  • Customer Standards
  • International Standard
  • Document request form

4.0 RESPONSIBILITY:

  • Management Representative / Quality Systems Manager
  • All concerned process heads

5.0 RESOURCES:

Competent Manpower, Computers, Printer & Internet connection, Stationery, International standards & specifications, XXX Procedures          

6.0 TERMS AND DEFINITIONS

Document: Information (meaningful data) and supporting medium

Procedure: XXX’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.

NOTE this definition was previously identified as a “control feature” in earlier editions of this specification.

Specifications: Document stating requirements

7.0 PROCEDURE

7.1 External Origin Standard

  • A Master list of External Origin Documents is maintained which is essential for the planning and operation of the Quality Management System.  The master list of external origin document is identified, controlled and updated as and when changes are made to the standard.
  • API product or other external specification requirements including addenda, errata & advisory details (revisions and updates) are updated and maintained by checking www.api.org website monthly wise
  • MR keeps tab on the versions of standards mentioned in master list of External origin standards on respective websites once in 6 months and updated if necessary.
  • Regarding revision of legal standards, once in three month, it is checked with authorized like PCB, Inspectorate of  Factories etc. and updated
  • Based on the Updation of External standards, the Technical Procedures are updated
  • All standards are collected by MR and review with Engineer – Design & Development, Operations, Quality Control in monthly basis
  • System related changes in Standards is identified and done by MR
  • Technical changes like design & development, Quality are identified by related Personnel (Engineer) and inform to MR
  • If any changes required from management side and those will be discussed in the Management Review Meeting and MR takes responsibility of it.

7.2 DOCUMENT CONTROL

  1. External Document are following,
    • Drawings
    • Specifications
    • Purchase Orders
    • Customer Standards
  2. Issue control of external documents lies with the QA/QC Engineer.
  3. Machine shop Manager/Operations Engineer shall ensure the latest editions of the drawings/specifications/other documents are available prior to the commencement of the work.
  4. If the copies of the Customer/OEM/Internal drawings are lost or damaged by the user departments, the department head makes a request to the QA/QC Engineer for issue of fresh copy of the drawings.
  5. Once the product realization process completed relevant documents shall be handed-over to the QA/QC Engineer.
  6. Copies of the external documents shall be disposed after use in controlled conditions and appropriate records shall be maintained.

8.0 OUTPUTS

Master List of External Origin Standards

9.0 Key performance indicator

All external origin documents available as per requirements & controlled.

10.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
Master List of External Origin StandardsXXX/MR/D 04Management Representative

Published by 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 .

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