Agenda• Introduction• Terminology & Nomenclature• Principles and Purposes of Documentation 7/12/2012• Document Hierarchy• SOPs• Document Preparation & Implementation• Good Documentation Practices• Summary
Introduction• World War II, the Britain MoD sought to reduce the amount of mistakes, and resulting accidents, during the manufacture of munitions. 7/12/2012• Dealing with suppliers, MoD insisted on seeing procedures for the making of a product, which then was inspected to ensure consistency.
Introduction• In (1966) the UK Government led a campaign for quality and reliability using the slogan 7/12/2012 o"Quality is Everyones Business."• In 1971, the British Standard BS 9000 was developed as a quality assurance standard for the electronics industry.
Terminology & Nomenclature• Document – “any supporting of evidence medium which is retrievable and traceable anytime during its life cycle”, this includes: 7/12/2012 SOP, Record, JD, Manual, CD, DVD, SAP, Picture, Label, Contract, Agreement, Memo, etc…
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 7/12/2012 manner.• “Approved Master Document” is an original signed document. The approval signature indicates approval for issuance and use.
Terminology & Nomenclature• “Controlled Document” refers to Standard Operating Procedures (SOP) and forms that have controlled distribution and are subject to Change 7/12/2012 Control procedures.• “Uncontrolled Document”: A document that is not subject to amendments, changes or revisions and not traceable.
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 7/12/2012 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.
Terminology & References• Record: Document stating results achieved or providing evidence of activities performed. 7/12/2012• 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”.
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 7/12/2012 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.
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. 7/12/2012• 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.
Purpose of Documentation• To ensure all personnel know what to do, when to do it and how?• Communication (Teams, coworkers, suppliers, 7/12/2012 customers, etc…)• Follow and comply with local laws, regulations International Standards• Provides audit trail
Principles of Documentation• Documents should be designed, prepared, reviewed and distributed with care. 7/12/2012• Documents should be approved, signed & dated by appropriate authorized persons; No document change without authorization (CCF Procedure)
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, 7/12/2012 No. , current version, effective date, page# A footer with control documentation statement Signatures History Record & distribution
Preparing a Document• Second page and so on in an SOP: Subsequent header & footer Purpose 7/12/2012 Scope Responsibilities Process Related Documents References
Preparing a Document• General considerations: Font type is times New Roman 7/12/2012 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
Preparing a Document• For example: ATC-QA/101: ATC- Advanced Technology Company QA- Acronym for Quality Assurance Section 7/12/2012 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
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. 7/12/2012• 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
Retention , Archiving & Destruction• SOPs must be current, controlled, accessible, retrievable and traceable. 7/12/2012• 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.
Review & Control of Documents• Documents shall be periodically reviewed. • Recommended once/year (min requirements)• QA & Document Control Center are responsible to 7/12/2012 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.
Document Hierarchy: Management Responsibilities & Authorities, Quality Manual and the elements of a QMS Quality Objectives 7/12/2012 Who, When, What, Where and How SOPs (Policies & Procedures) Evidence & Results Forms, Templates, Checklists, Records
Quality Manual• Describing the written organization’s policies• Scope of QMS 7/12/2012• Documenting quality policy & quality objectives• Description of organization• Identification of processes• Description of processes interactions• Inclusion or reference of procedures
Standard Operating Procedures• Documents that describe processes from area to another, or a combination of processes• Documents needed to ensure effective planning, 7/12/2012 operation, and control of the processes• Departmental specific• Step by step instructions
Forms, Templates, Checklists, etc… • Documents that specify the data requirements called out in the various documents and/or • Specific data sources, or graphically indicate 7/12/2012 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
Functions of SOPs • A planning document • A Guidance tool 7/12/2012 • A means of protection • A decision-making tool • An evidence of conformance
ProcessCurrent Situation What we need?Deficiencies Q-Steering CommitteeOpportunities for improvements Commitment 7/12/2012Variances Sourcing Documentation Training Action Request Audit (Internal & External) How much time do I need??
7/12/2012Documentation will drive you to your destination.
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
Good Documentation Practices• Concise: must tell the entire story and be understood by the reader; Standardized? 7/12/2012 Easy for all to use & follow? A complete story?• Legible: must be easy to read; Can everyone read what is written?
Good Documentation Practices• Accurate: must be free of error; Data shall be clear and not misleading 7/12/2012• Truthful: must be free of assumptions; Data shall be factual and not falsified
Good Documentation Practices• Traceable: must provide the activity, who recorded it, where, why & how; Sign for what you record 7/12/2012 Who signed for a particular activity When it was recorded History of the document or record
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
Summary• Not documented means: NOT DONE• SOPs are redundant if outdated, not implemented or not followed. 7/12/2012• 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