Document Control Procedute

Every Organization should have a documentation policy, Today I'll share a document control procedure for you so that you can maintain, Update, published, and disposed of your document maintaining international standard.

 

1.0  Purpose

To ensure that all documents comprising the quality management system are controlled and distributed so that those employees requiring them to use only current issues.

2.0  Scope

This procedure applies to all the sections or departments of an organization.

3.0  Responsibilities

The QMS Team Leader has responsibility for directing activities relating to this procedure. Where other functions have the responsibility, they are so indicated.

4.0  Procedure

4.1  Document Hierarchy

Level 1: Quality Manual

Level 2: Work Instructions, Procedures, Standards & Quality Plan

Level 3: Quality Records, Forms

Level 4: Register

4.2  Documents Identity

Title: Every document should have a title/ Name

Example: Document Control procedure.

Effective/Issue date: Document should be identified with an effective date ie effective date is the date when the document is approved.

Example: 01/04/2019

Revision No: Document should contain a revision no for each amendment. (Where the Status Start from 00, 01 than 02 like this) &

Document Number: Every document must have a unique identification number.

Example: QMSA/QMS/Mnl/001 where:

-          1st short form of the organization name like QMSA (QMS-Aid).

-          Then we’ll put the short form of the name of the department is responsible to maintain this ie QA (Quality Assurance).

-          After that we’ll put the short name of the document like Manual (Mnl), Work Instruction (WI), Standard Operating Procedure (SOP), Records/ Forms (FO), Register (REG) etc. 

    

And finally, we’ll put the serial no of the document like 001, 002, 003 ….. This serial number will start from 1 for each department & document type or organization & continue.

4.3  Short form of the various department can be used-

HAC = HR (Human Resource), Admin & Compliance

PUR = Purchase

PRD = Production

QA = Quality Assurance

MNT = Maintenance

STR = Store

ACC = Accounts

EN = Engineering

IE = Industrial Engineering

SAM = Sample

Elec = Electrical

Mec = Mechanical

4.4 Document Approval (Level 1 & 2)

4.1.1The appropriate personnel involved with the activity write documents.

4.1.2 Approvals: Manual/SOP/Form Approval: Respective Department Head > QMS Responsible >   COO/Director.

4.5  Issuing Documents (Level 1 & 2)

4.5.1     The original document, signed, unstamped, and dated is retained in the Central Quality File.

4.5.2     All Level 1 & 2 documents copies issued to a department are printed “Controlled Copy” are recorded on a Controlled Document Master List, for each department/function.

4.5.3      A Circulation Record accompanies the original document.

4.5.4    Copies of documents are distributed to the appropriate personnel who sign the Circulation Record.

4.5.5   Uncontrolled photocopies or prints are allowed for use by external parties, e.g. customers, auditors, etc. These are printed on each page as “Uncontrolled Copy”.

4.6  Amending Documents (Level 1,2 & 3)

4.6.1       Changes required are raised on a Change Proposal, and submitted to the QMS Team Leader.

4.6.2    The review and approval of proposed change is only by the functional authorities, which initially wrote and approved the document.

4.6.3    If the changes are approved a new issue is published. The issue number advances, that is, Revision 01 becomes Revision 02,

4.6.4      The change(s)/new addition(s) are identified by underlining the amended section.

4.7  Withdrawal / Obsolete Documents/ Disposal

4.7.1        The amended document is issued and distributed according to procedure.

4.7.2        The Controlled Document Master List is updated.

4.7.3        All obsolete copies are withdrawn and signed for according to the Circulation Record.

4.7.4      The original copy of the obsolete document, along with its Circulation Record and Change Proposal, is kept for reference purposes, in an Obsolete Document File. The front page is red stamped “Obsolete”.

4.7.5        Old documents are stamped in red as “Obsolete”. They are retained, if required for reference, or destroyed/disposal on the authority of the concerned department head.

4.7.6        All remaining copies are destroyed.

4.8  Issuing & Amending Formats

4.8.1        Generation of formats is the responsibility of department heads.

4.8.2        They are printed on white paper and include a Document code number, Title and issue number.

4.8.3        A blank copy is attached to the relevant procedure or work instruction in the Central Quality file.

4.8.4        Copies are allowed for working activities.

4.8.5        Changes are made according to sections 3.5.1 and 3.5.2 and the issue number & Revision no advanced.

4.8.6        Amended issues are sent to the QMS Team Leader for inclusion in controlled copies of the relevant document. The Change Proposal and a copy of the obsolete document are kept in the Obsolete Document File.

4.8.7        Department heads are responsible for the withdrawal and destruction of old issues and distribution of new issues to the concerned work areas.

4.9  External Document

All the external document is identified By the Stamp External Document & distributed according to the procedure (see section 3.4).

Note: This process is not applicable to software.

5.0 Reference

Master List

Circulation Record

Change Proposal

6.0 Definition