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Document & Data Control

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MUHAMMAD ASIM (LA)
MUHAMMAD ASIM (LA)

Document control systems focus on ensuring the most current version of documents are used correctly. An effective system has clear documentation, the right amount, and outlines what will be controlled. It also plans infrastructure like hardcopy or software storage. Implementation involves collecting existing documents, reviewing for updates, notifying staff of changes, and replacing old documents to avoid common problems like inconsistent terminology, long revisions, or improper distribution.

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Document Control Basics of Good Documentation and Document (And Data) Control Systems Presented by: Muhammad Asim
Document Control: What is it. • Document Control activities focus on the adherence to the document lifecycle steps (i.e. preparation, review, approval, release, use/distribution, and change control).
Document Control • Advantages: – Assures that the most current version is used – Ensures availability when needed – Standardize the Processes & Work Methods – Facilitate improvement and to track the changes made in Processes / SOPs – Ensure we hold on to the gains made through small improvements
Steps to Building an Effective System • Elements of Good Documentation • How Much do I Need? • Outline Your Document Control System • Documentation Infrastructure – Hardcopy System – Manage in a Database – Document Control Software Packages • Implementation Steps for Documentation Control • Common Problems with Documentation
Annual Quality Survey Report • Identifies Document Control as the most difficult clause to implement... • And the most difficult clause to maintain.
Step 1 in Building an Effective System Is: To Have Good Documentation!
Good Documentation is: Clear Concise User friendly
Essential Features in a Document • Identify document uniquely • Identify revision number and/or date • Number pages • Show end of document – e.g. “Page 4 of 7” • Show who authorised
Avoid Drowning in Detail….. “The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”
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 herin are applicable to all operations in the following departments within their functional ambit”
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.
Step 2: Have the Right Amount of Documentation But how much documentation do I need?
Avoid Creating too much: Work instructions written for virtually everything Overlap and repetition - Including a process in more than one work instruction. Ask yourself: Will it really Impact Customer Requirements? Or…
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
Documentation: The right amount 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.
Step 3: Outline Your Document Control System
Outline document control system
Clarify Your Terminology: Procedure: Describes the process. Work Instructions: Tells how to perform the process. Attachment: Information attached to the procedure to help clarify the procedure. Forms, Tables, etc.: Places to record the results of tests, audits, etc. Records Procedures describe an overall process such as "Purchasing", where as work instructions would describe a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies".
More on Terminology • Documents: written policies, process descriptions, procedures, and blank forms – Used to communicate information • Records: worksheets, forms, charts, labels, – Used to capture information, activities, or results when performing a procedure • May be paper or electronic
Why are Records Essential? • For continuous monitoring • For Order tracking throughout process • To identify failures in equipment • To revisit information; reference • For use as a management tool
What Will You Control? • Procedures • Work Instructions • Forms • Attachments • Records • External Docs: Customer Drawings • Prints • Drawings • Routers/Traveler
Step 4: Where will you keep your documents?
Planning Your Infrastructure • You may choose: – A Hardcopy System – A Soft-copy System  An existing database program  A packaged document control software.
Hardcopy Systems
Simple Hardcopy System  The master electronic documents are stored in “Word” or “Excel”.  A Master list is prepared and kept in “Excel”.  Hard copies are copied on to paper that is marked “CONTROLLED”.
Simple Hardcopy System  The hardcopies are distributed to an identifiable ‘file’ 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.
Simple Hardcopy System  One person is designated as the Document Control Coordinator.  This person – keeps the master list up-to-date – Makes revisions to documents – Distributes revised documents – Collects the outdated documents
Simple Hardcopy System  A “Change Request Form” is available for employees to initiate revisions to documents. – Changes must be approved before they are made. – Changes are indicated by using the revision tool in Word. – Staff must be aware of revisions.
Documents of External Origin  These documents must be included in your document control system. For example: – Customer Prints – Industry Regulations – ISO Standards – References used for your documentation.
Documents of External Origin  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 your company).
Implementation Steps
Implementation Steps • Collect existing documents and records • Review and update • Determine additional needs • Develop or obtain – Documents, forms, worksheets, logbooks, reports – Involve stakeholders • Notify staff of change / new document • Old documents replaced by new • Master list of documents updated
Common Problems with Document Control
Common Problems Employees writing documents do not understand the difference between a Procedure and a Work Instruction. Terminology has not been defined, and is not used in a consistent manner. Revisions take too long, documents are not kept current.
Common Problems 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
Common Problems Approval Distribution Keeping distribution current
Common Problems Too many documents are distributed. The system cannot be maintained. Lack of control of documents of External Origin. Avoid these problems by planning ahead…
And all the pieces will fall in place.

More Related Content

Document & Data Control

  • 1. Document Control Basics of Good Documentation and Document (And Data) Control Systems Presented by: Muhammad Asim
  • 2. Document Control: What is it. • Document Control activities focus on the adherence to the document lifecycle steps (i.e. preparation, review, approval, release, use/distribution, and change control).
  • 3. Document Control • Advantages: – Assures that the most current version is used – Ensures availability when needed – Standardize the Processes & Work Methods – Facilitate improvement and to track the changes made in Processes / SOPs – Ensure we hold on to the gains made through small improvements
  • 4. Steps to Building an Effective System • Elements of Good Documentation • How Much do I Need? • Outline Your Document Control System • Documentation Infrastructure – Hardcopy System – Manage in a Database – Document Control Software Packages • Implementation Steps for Documentation Control • Common Problems with Documentation
  • 5. Annual Quality Survey Report • Identifies Document Control as the most difficult clause to implement... • And the most difficult clause to maintain.
  • 6. Step 1 in Building an Effective System Is: To Have Good Documentation!
  • 8. Essential Features in a Document • Identify document uniquely • Identify revision number and/or date • Number pages • Show end of document – e.g. “Page 4 of 7” • Show who authorised
  • 9. Avoid Drowning in Detail….. “The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”
  • 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 herin are applicable to all operations in the following departments within their functional ambit”
  • 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. Step 2: Have the Right Amount of Documentation But how much documentation do I need?
  • 13. Avoid Creating too much: Work instructions written for virtually everything Overlap and repetition - Including a process in more than one work instruction. Ask yourself: Will it really Impact Customer Requirements? Or…
  • 14. 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
  • 15. Documentation: The right amount 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. Step 3: Outline Your Document Control System
  • 18. Clarify Your Terminology: Procedure: Describes the process. Work Instructions: Tells how to perform the process. Attachment: Information attached to the procedure to help clarify the procedure. Forms, Tables, etc.: Places to record the results of tests, audits, etc. Records Procedures describe an overall process such as "Purchasing", where as work instructions would describe a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies".
  • 19. More on Terminology • Documents: written policies, process descriptions, procedures, and blank forms – Used to communicate information • Records: worksheets, forms, charts, labels, – Used to capture information, activities, or results when performing a procedure • May be paper or electronic
  • 20. Why are Records Essential? • For continuous monitoring • For Order tracking throughout process • To identify failures in equipment • To revisit information; reference • For use as a management tool
  • 21. What Will You Control? • Procedures • Work Instructions • Forms • Attachments • Records • External Docs: Customer Drawings • Prints • Drawings • Routers/Traveler
  • 22. Step 4: Where will you keep your documents?
  • 23. Planning Your Infrastructure • You may choose: – A Hardcopy System – A Soft-copy System  An existing database program  A packaged document control software.
  • 25. Simple Hardcopy System  The master electronic documents are stored in “Word” or “Excel”.  A Master list is prepared and kept in “Excel”.  Hard copies are copied on to paper that is marked “CONTROLLED”.
  • 26. Simple Hardcopy System  The hardcopies are distributed to an identifiable ‘file’ 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.
  • 27. Simple Hardcopy System  One person is designated as the Document Control Coordinator.  This person – keeps the master list up-to-date – Makes revisions to documents – Distributes revised documents – Collects the outdated documents
  • 28. Simple Hardcopy System  A “Change Request Form” is available for employees to initiate revisions to documents. – Changes must be approved before they are made. – Changes are indicated by using the revision tool in Word. – Staff must be aware of revisions.
  • 29. Documents of External Origin  These documents must be included in your document control system. For example: – Customer Prints – Industry Regulations – ISO Standards – References used for your documentation.
  • 30. Documents of External Origin  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 your company).
  • 32. Implementation Steps • Collect existing documents and records • Review and update • Determine additional needs • Develop or obtain – Documents, forms, worksheets, logbooks, reports – Involve stakeholders • Notify staff of change / new document • Old documents replaced by new • Master list of documents updated
  • 34. Common Problems Employees writing documents do not understand the difference between a Procedure and a Work Instruction. Terminology has not been defined, and is not used in a consistent manner. Revisions take too long, documents are not kept current.
  • 35. Common Problems 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 Too many documents are distributed. The system cannot be maintained. Lack of control of documents of External Origin. Avoid these problems by planning ahead…
  • 38. And all the pieces will fall in place.

Editor's Notes

  • #9: What is required within a Document ? The version of each QMS document must appear on the document. This may be in the form of a revision number or a date. Both revision number and date sometimes appear, but this is not essential, and using both sometimes makes errors possible. It is essential for pages to be numbered. It is also essential to show where the document ends, so that misinterpretation cannot occur due to the physical loss of pages from the end of the document. Commonly this is done by numbering pages in the style “page 4 of 7”. However, a statement such as “End of Document” will serve just as well. Care should be exercised in using the page numbering features of word processing software. It is possible to accidentally generate a document with the wrong total page number. This may lead to a final page numbered as e.g. “page 8 of 6”. This is a breach of document control.