1. DOCUMENTATION FOR MANAGEMENT SYSTEMSBy
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: 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

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. 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.

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

10. 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

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

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
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

25. 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

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.
PREPARED BY *NAME AND
DESIGNATION
APPROED AND ISSUED BY
*NAME AND DESIGNATION

29. 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

30. Thank you