DOCUMENTATION FOR MANAGEMENT SYSTEMS By Gp. Capt. Najamuddin

Documentation for MSs Why Document a System? Enables communication of intent. Ensures consistency of action Source for clearly identifying responsibility and authority

Documentation for MSs Its use contributes to: Achievement of conformity to requirements and quality improvement Provision of Appropriate Training Provides permanent reference for: Implementation of MS Maintenance of MS on day-to-day basis

Documentation for MSs Its use contributes to: Repeatability and traceability Leads to clarity in thinking (common understanding) Avoids differing perception of how to do work End of Ad-hoc and fire-fighting approach to management Provision of objective evidence of actions taken.

Documentation for MSs Its use contributes to: PIT FALLS Evaluation of effectiveness and continuing suitability of MS Provides a basis for Audit – Monitoring and Evaluation of System Important vehicle for Change Management Brings transparency to operations PIT FALLS Generation of documentation becomes an end in itself It should be a value-adding activity

Documentation for MSs MS Documentation includes a) Policy Statements b) Quality Manual c) Procedures d) Processes/Quality Plans e) Work Instructions/Standard Operating Procedures f) Specifications/Standards g) Forms

Documentation for MSs The documents could be: Internally generated, or Externally source Documents may be in any form: paper (hard copy) electronic (soft copies) web based systems Photographs master samples

Documentation for MSs MS documentation may differ from one organization to another due to: size of the organization and type of activities; complexity of operations; competence of personnel.

Documentation for MSs Structuring 0f Documentation: Advantages of Structuring Ease Of Distribution Confidentiality

DOCUMENT RELATIONSHIP LEVEL DOCUMENT RESPONSI-BILITY FUNCTION I. Quality Manual Strategic Top Management or QM II. Q. Procedures - Affecting all Departments Tactical QM III. Work Instructions/ SOP’s Operational In-charges/ Actual users

Document Relationship (Contd) IV. Forms, Lists, Records Affecting all Departments Limited to Section/Deptt. Operational Concerned Department/ Person

Documentation for MSs Quality Manual : Document Specifying MS of a CB. Quality Procedures : Documents that provide information about how to perform activities and operations consistently at a system/ administrative level Work Instructions/Process maps, etc : Documents that provide detailed information about how to perform activities and operations consistently at an operational level.

Documentation for MSs Forms, Formats (Level-IV) which when filled become Records. Record: Special type of documents stating results achieved or providing evidence of activities performed.

QUALITY MANUAL Quality Manual Intent document Document outlining the policies and practices and the systems of the Certification Body, used for the purpose of implementing the CAs. Purpose of this document is to present broad guidelines to assist the CB to describe in a systematic way, the methodology it uses to implement its management system.

Structure of Quality Manual Cover page Amendment sheet Distribution list Contents Definitions Profile of the CB Historical background Scope and field of activities And any other significant details

Structure of Quality Manual Statement of quality policy and objectives Responsibility and authority Organization chart Document control details Structure of documentation Description of quality system elements Inclusion or reference to system / operational procedures or to any other levels of documentation Index, if necessary.

Structure of Quality Manual Revision/issue status Issue no. Each section undergoing changes Revision no.(may change) When all the sections of quality manual are revised to a new volume Usually when 5 or 6 changes are incorporated It is a good practice to write the manual after other documentation has been completed as reference to procedures is normally required in the description of Management System

Procedures Procedures Intended to instruct the workforce in broad terms how policies and objectives expressed in quality manual are to be addressed and achieved. Operating document for carrying out any management system activity pertaining to relevant clause of the applicable Standard. It should be updated with respect to any change in practices. Authority for approval and document control should be identified.

Procedures Should describe accurately the description of activity and define control points Use simple language using present tense [Exp: Purchase order is verified by Manager (Purchase)] Following information or description are provided through procedures: All inputs to the relevant activity All outputs arising out of the activity Precautions to be observed Interfacing requirements

Procedures Develop procedures on the logic of 5 WS. What is procedure about – Title Why is the procedure needed – Purpose When and where required to be used – Scope Who - Responsibility How – Procedure details

Procedures Procedures should also : Give clear references to any other document required to be referred; Supportive information, if any; Records generated.

Procedures (contd.) Suggested Format: Purpose or Objective – Intent of the Document. Scope or Application – Area, Department, group or personnel to which procedure applies. References or Associated Documents – List of Documents, both Internal and External to be consulted in regard to procedure. Definitions – Words, abbreviations, or phrases not understood clearly by all concerned.

Procedures (contd.) Suggested Format (Contd): Procedure – details of the action required by personnel involved in the activity. Who does what and how? Where, when and possibly why? Documentation and records – Specimen format (Document) and records to be generated. Control information.

Common Format Of Procedure PREPARED BY APPROVED BY/ ISSUED BY *NAME AND *NAME AND DESIGNATION DESIGNATION Revision No. NAME OF THE CB LOGO OF ORGN. Issue No. Issue Date CONTROLLED COPY Page: 1 of PROCEDURE FOR CONTROL OF RECORDS DOC. NO: XYZ/QP/0801

Work Instructions, Sop’s Detailed instructions to users, on how an activity is to be done & its control system Examples : Instructions for sample drawal, packing and sealing. Convey to the user actual steps required to be followed List out correct sequence of activities Should use very simple language Include conditions, references, records

Work Instructions, Sop’s Types of Work Instructions: Verbal Written Drawings Photographs Checklists Computer Menu Options

Format of Work Instruction Revision No. NAME OF WORK INSTRUCTION LOGO OF ORGN. Issue No. Issue Date CONTROLLED COPY Page: 1 of Instructions for Drawal of sample, Packing and Sealing DOC. NO: XYZ/WI/QMORQP REF/SL

Format Of Work Instruction Select a 25 Kg bag of milk powder from the representative lot using statistical techniques as described in. Transfer the sample from the 25 Kg bag to a 500 gm sterilized glass bottle under aseptic conditions. Tightly secure the lid and tie the same with cloth and seal the tied edges with lakh seal. PREPARED BY *NAME AND DESIGNATION APPROED AND ISSUED BY *NAME AND DESIGNATION

Structure of a Format Format/ Form / List Mass of supporting documents used by the CB to record and distribute information in support of its Management System Examples Audit / Inspection Report format Personnel authorization form Periodic monitoring form Format for Training records Internal audit report format Format for non-conformity report

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