Example for procedure for Control of Documents

Uncategorized 6 Minutes

1.0  PURPOSE:

This procedure outlines the method for control of documents to ensure that the appropriate revisions of the documents are available with the user. It also addresses responsibilities for approval and re-approval and identifies the controls needed to ensure that the documents required by the Quality management system including revisions, translations, and updates.

2.0 SCOPE:

Applicable to all documents related to documented Quality management system generated internally and externally.

This procedure is applicable to all the levels of documents pertaining to:

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

3.0 INPUTS

Need for new documents, Document request form, International Standard, Customer requirements, XXX procedures requirement.

4.0 RESPONSIBILITY:

  • Management Representative
  • Manager – Design & Quality Systems
  • All concerned process heads

5.0    RESOURCES:

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

6.0 PROCEDURE:

The procedure specifies responsibilities for approval and re-approval and identifies the controls needed to ensure that the documents required by the Quality management system, including revision, translation, and updates are available where the activity is being performed and remains legible and readily identifiable.

  1. The XXX manual for Quality management system is the Quality System Manual. The Master copy of Manuals is available in hard. Responsibility of updating Quality Management System Manual lies with the Management Representative.
  2. Quality Management System Procedure are linked to Quality Management System Manual
  3. Quality Procedures are mapped as per defined processes in Quality Management System Manual.
  4. Quality Systems Manager updates them in hard and soft. Prior to the issuance of the documents, the Management Representative has reviewed the copy for its adequacy, legibility and for in line with ISO 29001: 2022/ API Spec Q1, 9th edition, API Spec …, API Spec …., API Spec …, API Spec … and API Spec … requirements, gets it approved from the top authority in XXX.
  5. All such documents identified by a unique serial number (Copy No) and the copy number logged in the issue register for future reference.

6.1 PREPARATION OF DOCUMENTS:

All the documentation of Quality Management System is prepared by Management Representative by taking inputs from all process heads & concern personnel. When creating and updating documented information, XXX ensures appropriate:

  1. Identification and description (e.g. a title, date, author, or reference number)
  2. Format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
  3. Review and approval for suitability and adequacy.

6.2 DOCUMENT IDENTIFICATION: –

All Quality Procedures and level 3 documents have their reference number, revision date, and revision number, page number, title as appropriate. Each document has unique identification.

DOCUMENT STATUS IDENTIFICATION:

Sr. NoDescriptionIdentificationColor
1.All Master copiesMaster Copy (on front side of document and for document with multiple pages it is mentioned in the contents page with Signature of the MR)Blue
2.All Controlled copiesControlled Copy (on front side of document and for document with multiple pages it is mentioned in the contents page with Signature of the MR)Blue
3.For all obsolete copiesOBSOLETE COPY (on front side of document and for document with multiple pages it is mentioned in the contents page with Signature of the MR)Red

6.3 ISSUE CONTROL:

  • Master copy stamped in Blue color on the document and is used for taking photocopies for the purpose of issuing copies.
  • Record of issue is maintained in Record of Issue and Distribution and kept with master copy only.
  • For 01 issue documents the revision status is 00. Whenever there is any change in particular document the revision number is raised as 01, 02 to 09.
  • For major changes, issue number will be incremented.
  • The issue number is raised to next issue number in following circumstances.
  • Whenever there is any major change in API Q1 Spec requirements/ISO 29001/2020.
  • Major changes in Company’s Organization.
  • Whenever Revision number of any particular document will go above 09.

6.4 NEW DOCUMENT/CHANGE CONTROL:

    • The employee who desire or suggests any new document or change in the document shall raise a New Document Request form and Document change request respectively. Requesting it to MR for reviews. Approval authority to takes decisions whether to include a document or revise that document or not.
    • If the document is to be newly implemented or revised, MR shall take the approval from the authority that has originally approved the document.
    • The nature of document changes is communicated to concerned departments through the document-change note.
    • The revision in the level 2 and 3 documents are recorded in Record of Revision and Distribution by MR and are kept with Master copies. Control copyholder can refer to these sheets as and when required to know revision in their documents.
    • The document change request indicates the effective date for implementation of change.
    • MR issues the revised document to all concerned as detailed in record of revision and distributions.
    • MR ensures that all the obsolete copies are received back from concerned persons. All obsolete copies shall be destroyed except master copies of previous version.

    6.5 DOCUMENT MASTER LIST:

      • MR has a master list of all documents, which shows the current issue status and revision status of the document.
      • Whenever there is any revision in the document MR updates master list of that particular document.

      6.6 RESPONSIBILITY OF USER DEPARTMENT:

        • It is responsibility of the Quality Systems Manager to ensure that the updated copies are available with the controlled copy holders and shall ensure to remove the obsolete copies from use.
        • All controlled copyholders shall make available relevant procedures, work instructions, and check lists formats and any other documentation to the employees working under them. They ensure that procedures and work instructions are understood and implemented in day to day working by concerned persons.

        6.7 CONTROL OF EXTERNAL ORIGINAL DOCUMENTS:

          • All International standards, code or specification required for the manufacturing controlled by the Design & Quality Systems Manager/ or his designee by periodic check.
          • Any changes (revision or addenda) obtained and incorporated within the system
          • A master list for External Origin standards maintained and controlled accordingly and also ensures that the relevant version are used and maintained.
          • In case of any such changes to the relevant specification, which affect the company management systems or documents, such reviewed and necessary changes to be made accordingly.
          • Supplier’s technical manual and their data sheets are stored in XXX Technical Library.
          • All official documentation such as commercial registration, registration with chamber of commerce, memorandum of association, import export license, approval from various departments (fire, water, electricity etc.) maintained by the administration department under the direct supervision of HR Manager.
          • XXX controls procedure, work instruction and forms required the Quality management system.

          6.8 CONTROL OF DOCUMENTS STORED IN ELECTRONIC MEDIA

            • Utmost care shall be taken while storing data in electronic media.
            • Only authorized users shall be allowed to use the data.
            • Wherever possible, data shall be protected by providing passwords.
            • Regular back up shall be taken to avoid data loss or damage / corrupted.
            • Data shall be protected from viruses by using latest anti-virus programs.

            6.9 DOCUMENT CONTROLS

            Sl. No.DocumentUserControl
            1.Quality Management System ManualAll Process heads & applicable usersWith MR / Top Management / Hardcopy / Softcopy
            3.Quality Management System ProceduresAll Process heads& applicable usersWith MR / Top Management / Hardcopy / Softcopy
            5.Work instructions (WI)/ Quality Internal Procedures (QIP)All Process heads & applicable usersWith MR / Top Management / Hardcopy / Softcopy
            6.RecordsDepartment usersRespective Department Manager/In-charge

            6.10 APPROVAL & RE-APPROVAL AUTHORITY

            Level 01           Quality Manual                       Chairman

            Level 02           Quality Procedures                 Chairman

            Level 03           Work instruction / QIP            MR/Process Heads/Machine Shop Manager

            Level 04           Formats/Records                    MR / Process Heads/Machine Shop Manager

            6.11 REVIEWING AUTHORITY

            Level 01           Quality Manual                                   MR

            Level 02           Quality Procedures                             MR

            Level 03           Work instruction / QIP                        MR / Process heads

            Level 04           Formats/Records                                MR / Process heads

            7.0 OUTPUTS

            New documents, Forms & formats

            Revised documents

            8.0 Key performance indicator

            All documents are available as per requirements of International standard, XXX procedures & customer.

            9.0 ASSOCIATED DOCUMENTS & RECORDS

            DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
            Master list of DocumentsXXX / MR / D01Management Representative
            Master list of QMSPXXX / MR / D03Management Representative
            Master list of External Origin StandardsXXX / MR / D04Management Representative
            Master list of Quality Policy DisplayXXX / MR / D06Management Representative
            Master list of Quality Internal ProceduresXXX / MR / D08Management Representative
            Master list of Work InstructionsXXX / MR / D11Management Representative
            Master list of NDT ProceduresXXX / MR / D12Management Representative
            Document Change RequestXXX / MR / 01Management Representative
            New Document Request FormXXX / MR / 01AManagement Representative
            Document Control & Issue RegisterXXX / MR / 02Management Representative
            Document Amendment RegisterXXX / MR / 03Management 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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