The document discusses documentation principles and practices. It introduces terminology used in documentation. It emphasizes that documentation ensures consistency, communication and regulatory compliance. It outlines the document hierarchy and types of documents like SOPs, forms and records. It discusses preparing, revising, reviewing and controlling documents. It also provides seven good documentation practices.

1. 7/12/2012
Presented to Q-Steering Committee
Wednesday 20June-2012
By: Bilal Al-kadri
http://kw.linkedin.com/in/balkadri

2. Agenda
• Introduction
• Terminology & Nomenclature
• Principles and Purposes of Documentation
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• Document Hierarchy
• SOPs
• Document Preparation & Implementation
• Good Documentation Practices
• Summary

3. Introduction
• World War II, the Britain MoD sought to reduce
the amount of mistakes, and resulting
accidents, during the manufacture of munitions.
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• Dealing with suppliers, MoD insisted on seeing
procedures for the making of a product, which
then was inspected to ensure consistency.

4. Introduction
• In (1966) the UK Government led a campaign for
quality and reliability using the slogan
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o"Quality is Everyone's Business."
• In 1971, the British Standard BS 9000 was
developed as a quality assurance standard for
the electronics industry.

5. Terminology & Nomenclature
• Document – “any supporting of evidence medium
which is retrievable and traceable anytime during
its life cycle”, this includes:
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SOP, Record, JD, Manual, CD, DVD, SAP, Picture,
Label, Contract, Agreement, Memo, etc…

6. Terminology & Nomenclature
• “Change Control”: refers to a formal process used
to ensure that changes to a controlled document
are introduced in a controlled and coordinated
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manner.
• “Approved Master Document” is an original signed
document. The approval signature indicates
approval for issuance and use.

7. Terminology & Nomenclature
• “Controlled Document” refers to Standard
Operating Procedures (SOP) and forms that have
controlled distribution and are subject to Change
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Control procedures.
• “Uncontrolled Document”: A document that is not
subject to amendments, changes or revisions and
not traceable.

8. Terminology & Nomenclature
• “Effective Date” is the date that a document
becomes effective for use. The time difference
between the Issuance and Effective Dates is to
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ensure adequate time for personnel training prior
to procedure implementation.
• “Issuance Date” is the date that a controlled
document is finalized and issued to a department.
The document does not become effective for use
until the effective date.

9. Terminology & References
• Record: Document stating results achieved or
providing evidence of activities performed.
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• Policy: “A predetermined course of action
established as a guide toward accepted business
strategies and objectives”
• Procedure: “A method by which a policy can be
accomplished; it provides the instructions
necessary to carry out a policy statement”.

10. Terminology & References
• Regulatory Compliance (RC) used to describe the
policies and processes which organizations have in
place to ensure that they follow the very many
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laws, rules and regulations put in place.
• Quality Management System (QMS): Management
system to direct and control and organization
with regards to quality.
• Quality Control: Part of the quality management
focused on fulfilling quality requirements.

11. Terminology & References
• Standard Operating Procedure (SOP): A document
describing how a certain part of a process shall be
done, including who is responsible for which tasks.
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• Quality Assurance: All actions that are taken to
ensure that a development organization delivers
products that meet performance requirements
and adhere to standards and procedures.

12. Purpose of Documentation
• To ensure all personnel know what to do, when
to do it and how?
• Communication (Teams, coworkers, suppliers,
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customers, etc…)
• Follow and comply with local laws, regulations
International Standards
• Provides audit trail

13. Principles of Documentation
• Documents should be designed, prepared, reviewed
and distributed with care.
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• Documents should be approved, signed & dated by
appropriate authorized persons;
 No document change without authorization
 (CCF Procedure)

15. Preparing a Document
• ATC adopts its own style in designing SOPs and
follows a standard format (first page):
A header with company’s logo, SOP title, type,
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No. , current version, effective date, page#
A footer with control documentation statement
Signatures
History Record & distribution

16. Preparing a Document
• Second page and so on in an SOP:
Subsequent header & footer
Purpose
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Scope
Responsibilities
Process
Related Documents
References

17. Preparing a Document
• General considerations:
Font type is times New Roman
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Font size 11 point header/footer, 12 point for
text, 12 or 13 bold for (sub) Section titles
Date format: dd-mm-year
Each SOP has a unique identifying number

18. Preparing a Document
• For example: ATC-QA/101:
ATC- Advanced Technology Company
QA- Acronym for Quality Assurance Section
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101-a 3-digit SOP number
• Examples of indexing for other sections unless
chosen by process owners:
• Finance – FIN; Purchasing– PUR;
• Human Resources – HR; Warehouses – WHS;
• Regulatory Compliance-RC; Laboratory- LAB

19. Revising a Document
• To initiate a document change or draft a new SOP,
the originator must initiate a CCF & follow “Change
Control Management” SOP No: ATC-QA/102.
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• If a document undergoes a substantive revision,
version number will increase by a full increment
• Version 1.0 to 2.0
• If a document undergoes a substantive revision,
version number will increase by a single digit
• Version 1.0 to 1.1

20. Retention , Archiving & Destruction
• SOPs must be current, controlled, accessible,
retrievable and traceable.
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• Obsolete documents that are no longer used by a
department shall be retained for min 2 years.
• Financial records are retained for lifetime.
• Electronic documents shall always be controlled.

21. Review & Control of Documents
• Documents shall be periodically reviewed.
• Recommended once/year (min requirements)
• QA & Document Control Center are responsible to
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ensure that issued documents are
controlled, effective and implemented
• Use of electronic signatures, as well as electronic
maintenance and submission, is an acceptable
substitution for paper, when practical.

22. Document Cycle
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23. Document Hierarchy:
Management Responsibilities & Authorities,
Quality Manual and the elements of a QMS
Quality Objectives
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Who, When, What, Where and How
SOPs (Policies & Procedures)
Evidence & Results
Forms, Templates, Checklists, Records

24. Quality Manual
• Describing the written organization’s policies
• Scope of QMS
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• Documenting quality policy & quality objectives
• Description of organization
• Identification of processes
• Description of processes interactions
• Inclusion or reference of procedures

25. Standard Operating Procedures
• Documents that describe processes from area to
another, or a combination of processes
• Documents needed to ensure effective planning,
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operation, and control of the processes
• Departmental specific
• Step by step instructions

26. Forms, Templates, Checklists, etc…
• Documents that specify the data requirements
called out in the various documents and/or
• Specific data sources, or graphically indicate
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requirements or state specifications
• Many of the forms are used as records once they
are filled in and filed, although specific records are
required at all levels
• Complementary documents to SOPs

27. Documentation Project
Top Management
LAB

28. Functions of SOPs
• A planning document
• A Guidance tool
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• A means of protection
• A decision-making tool
• An evidence of conformance

29. Process
Current Situation What we need?
Deficiencies Q-Steering Committee
Opportunities for improvements Commitment
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Variances Sourcing Documentation
Training
Action Request
Audit (Internal & External)
How much time do I need??

30. 7/12/2012
Documentation will drive you to your destination.

31. Good Documentation Practices
• Documentation is:
oAn objective evidence to promote consistency
and truthfulness in customer care & workplace.
oAn effective communication among members of
the team and coworkers.
7 GDPs shall be put in practice

32. Good Documentation Practices
• Concise: must tell the entire story and be
understood by the reader;
Standardized?
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Easy for all to use & follow?
A complete story?
• Legible: must be easy to read;
Can everyone read what is written?

33. Good Documentation Practices
• Accurate: must be free of error;
 Data shall be clear and not misleading
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• Truthful: must be free of assumptions;
 Data shall be factual and not falsified

34. Good Documentation Practices
• Traceable: must provide the activity, who recorded
it, where, why & how;
 Sign for what you record
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 Who signed for a particular activity
 When it was recorded
 History of the document or record

35. Good Documentation Practices
• Prompt: must be documented at the time the
activity performed;
 Do not use sticky notes or mark on hands
 Don’t blindly trust your memory
• Permanent: must not be erasable or fade overtime;
 Do not use pencils “can be erased”
 Use ball point blue or black ink

36. Summary
• Not documented means: NOT DONE
• SOPs are redundant if outdated, not implemented
or not followed.
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• Documents must be standardized across all
• Objective evidence proves that something exists
and true.
• Good Documentation Practices is a crucial part of a
well reputed company