Training On Document Control Appropriately
- 1. Document Control Document Control 1 Basics of Good Documentation and Document Control Systems
- 2. Document ? An approved instruction either in paper or electronic form which guides about how an activity shall be executed 2 • Communication of information • Evidence of conformity • Knowledge sharing
- 3. Document Control ? Have you ever found a version of a document and wondered if it was the latest one ? Have you ever questioned if the document that you have found is actually valid and up to date? 3
- 4. 4 A standardized practice that manage authentication, versioning, security, distribution and preservation of organization’s valued documents assets.
- 5. 5 It provides- Clear Identification Regulatory compliance Audit trails methods to prevent unauthorized access accidental loss use of obsolete documents Recovery when needed
- 6. Steps to Building an Effective System 6 • Elements of Good Documentation • How Much do We Need? • Outline Your Document Control System • Maintaining Documentation – Manual Filing/Word Processing Software – Manage in a Database – Document Control Software Packages • Common Problems with Documentation
- 7. Good Documentation Documentation must be- •Accurate: true, precise / error free •Concise: short & clear information that is understood by all •Legible: shall be readable •Traceable: who recorded it, where, when and how •Enduring: long lasting and durable •Accessible: easily available / retrievable 7 Clear Concise User friendly
- 8. Principles of Good Documentation • A document with original signatures should never be destroyed • Never falsify information • Never obliterate information or record • Never over write a record • Never use pencil- use permanent ink for writing • No spaces, lines or fields are to be left blank • Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive entry 8
- 9. 9 Avoid Drowning in Detail….. “The purpose of this procedure is to document the aforementioned activities, herein after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherein such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”
- 10. 10 And poorly written procedures • Why use ten words when one will do? “The items hereinunder referenced in some cases fell excessively outside normal parameters.” “The procedures contained herein are applicable to all operations in the following departments within their functional ambit”
- 11. 11 Make procedures user friendly Use short sentences starting with a verb. Avoid using the passive voice. Make it clear who is performing the task. Use white space for easy reading.
- 12. Observation on poor documentation • Missing signature and dates at the time of activity performed • Non-uniform date and signature • Activity was performed & writing on one day and signed on another day • Blank spaces • Illegible writing • Too many corrections • Write overs, multiple line through • Not traceable • Data integrity 12
- 13. 13 How much documentation do I need?
- 14. 14 Ask yourself: Will it really Impact Customer Requirements? Avoid Creating too much: Work instructions written for virtually everything Overlap and repetition - Including a process in more than one work instruction.
- 15. 15 Too little: Lack of work instructions where the process affects the quality of the product. Employees have their own way of performing processes There is variation in the process because it is not well documented
- 16. • Remember that the goal here is consistency for your processes • If two trained employees were to perform this task, would they do it the same way? • If the answer to this is “Maybe not” a work instruction is appropriate 16 Documentation the right amount:
- 17. “If the foundation of our documentation process is not reasonable, everything that follows won’t be useful as could be. This is why it’s important to know how to document” 17
- 18. 18 Outline your document control system
- 19. 19 Outline of document control system Level 01 Level 02 Level 03 Level 04 Quality manual Description of QMS Procedures Processes Instructions Activities Forms & Checklists Records
- 20. Procedure: Describes the process Work Instruction: Tells how to perform the process Attachment: Information attached to the procedure to help clarify the procedure Form & Record: A form is a document, when the form is filled out it becomes a record. 20 Clarify Your Terminology:
- 21. Procedures Work Instructions Forms Attachments External Docs: Customer drawings / contractor documents Prints Drawings 21 What will you control:
- 22. “Document control is having a way to ensure that information remains relevant, up to date, accessible and aligned to the strategy” 22
- 23. 23 Where will you keep your document?
- 24. ISO 9001 provides a general requirement for organizations. • but, it does not establish a minimum of approvals required • it does not provide a format for documents You prepare your own blue print You may choose: • A simple word processing program. For example, Microsoft word • An existing database program • A packaged document control software 24 Planning your Infrastructure
- 25. Choose a system for your company based on. • Company Size • Computer set up and availability • Number of different processes performed • Rate of change for your processes or documents 25 What will be best for your company
- 26. For example: • One for quality system documents and • One for engineering documents These documents may be different enough to make it best to have two distinct systems 26 Company may need more than one Type of system
- 28. The master electronic documents are stored in “Word” A master list is prepared and kept in “Excel” Hard copies are copied on to paper that is marked “Controlled” 28 Simple Hardcopy System
- 29. The hardcopies are distributed to 3 ring notebooks throughout the facility – The master list indicates what procedures and work instructions need to be in each book – Copies are kept to a minimum by only distributing relevant documents to each area. One person is designated as the document control coordinator, who – – keeps the master list up to date – Makes revisions to documents – Distributes revised documents – Collects the outdated documents 29 Simple Hardcopy System
- 30. A “Change Request Form” is available for employees to initiate revisions to documents – Changes must be approved before they are made – Changed are indicated by using the revision tool in word – Staff must be aware of revisions 30 Simple Hardcopy System
- 31. A database is set-up to hold procedures and work instructions – Lotus notes – Packaged system This may be organized into a “Chapter System” with a chapter of each clause of the standard. Procedures and work instructions are written in or loaded into the system Employees are given “Rights” – System administrator – Author – Editor – Approver – Read only 31 Online system
- 32. Authors write the procedures or work instructions The document is sent to the editor and approver for approval When it is approved it is automatically moved into the “Quality Documents” and becomes available to all these with read rights The documents may be viewed on the screen or printed Printed documents are controlled by a “sunset clause” – The date printed appears on all printed documents. Documents are valid only for the day they are printed. 32 Online system
- 33. Some hardcopy distribution may be necessary A master list must be kept for distributed documents Controlled hardcopies need to be identified Revisions are made by the author, and must be reviewed and approved by the editor and approver The author must determine if the changes affect any process that is being performed that day 33 Online system
- 34. A master list indicating the current revision of each print is maintained – This is usually in the manufacturing software A master file of the current print revisions is maintained – Simple file cabinet system – An electronic CAD system If prints are distributed to each operation they must be controlled – Operators verify against electronic master list – Prints are copied and labeled with a job number – The copy is good only for job number 34 Engineering Prints
- 35. These documents must be included in your document control system. For example- – Customer prints – Industry regulations – ISO 9000 standards – References used for your documentation – Contractor documents Control these by having a section on your master list for documents of external origin. Include: – Document name – Current Revision – Document Location (s) – Document number assigned by company 35 Documents of external origin
- 36. 36 Common Problems with Document Control
- 37. Employees writing documents do not understand the difference between a procedure and work instruction Terminology has not been defined, and is not used in a consistent manner Revisions take too long, documents are not kept current There is no process for tracking changes or training on changes Inconsistent use of other documents such as: » Forms » Attachments » Drawings » Documents of external origin 37 Common Problems
- 38. Approval Distribution Keeping distribution current Too many documents are distributed, the system cannot be maintained Lack of controls of documents of external origin Avoid these problem by planning ahead 38 Common Problems
- 39. “IF YOU HAVE NOT DOCUMENTED AN ACTIVITY YOU HAVE NOT DONE IT” Document all the activities performed Do not perform the activity if it is not documented THANKS FOR YOUR ATTENTION!! 39
Editor's Notes
- #7: It is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.
- #8: It is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.
- #10: Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.
- #11: Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.
- #12: It is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.
- #14: Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.
- #15: Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.