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)
14.
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.
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
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??
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
