Documentation for Management Systems

1. DOCUMENTATION FOR MANAGEMENT SYSTEMS By Gp. Capt. Najamuddin

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

3. 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

4. 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.

5. Documentation for MSs • Its use contributes to: • 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

6. 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

7. 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

8. DocumentationforMSs • MS documentation may differ from one organization to another due to: • size of the organization and type of activities; • complexity of operations; • competenceof personnel.

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

10. DOCUMENT RELATIONSHIP

11. Document Relationship (Contd)

12. 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.

13. 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.

14. 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.

15. 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

16. 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.

17. 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

18. 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.

19. 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

20. 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

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

22. 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.

23. 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.

24. Common Format Of Procedure 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

25. Work Instructions, Sop’s • Work instructions • 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

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

27. 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

28. 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.

29. StructureofaFormat • 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

30. Thank you