Quality System Procedure - Document Control and Management

Most recently edited by: Paul VanderWeele
Most recent edit date: Jan 2, 2021
Edits were authorized by: Paul VanderWeele

Purpose

To control all quality management system documents (internally generated and from external sources). To identify changes/revisions made to documents. To control amendments to documents by hand. To control documents maintained in computerized systems.

Document control ensures that: authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed documents are periodically reviewed and where necessary revised to ensure continuing suitability and compliance with applicable requirements invalid or obsolete documents are promptly removed from all points of issue or use to assure against unintended use obsolete documents retained for either legal or knowledge preservation purposes are suitably marked

Scope / Field of Application

This procedure applies to the Quality Manual, test methods, and standard operating procedures. Also applies to externally generated quality management system documents. Note – While there are standard formats for writing test methods and SOPs, documents may take on different formats. These formats may consist of signs, flowcharts, pictures, drawings, sketches, forms, and bulletized lists. Regardless of the format, all quality management system documents must be controlled through this procedure.

Definitions and Acronyms

Quality manual – document stating the quality policy, quality management system, and quality practices of an organization.

Standard operating procedure (SOP) – a document that specifies or describes how an activity is to be performed. It may include methods to be used and sequence of operations. Responsibilities

Laboratory management ensures that this document control procedure is established, implemented and maintained. The Quality Manager oversees the day-to-day operations of document control. Laboratory personnel are responsible for following this procedure in its entirety. Materials Required

“Controlled Copy” colored ink stamp “OBSOLETE” colored ink stamp Master list Procedure The Quality Manager maintains a master list of all controlled documents. Quality Manual:

  1. The Quality Manual is approved by the President and the signature of this approval is kept on file by the Quality Manager.

  2. Controlled hard copies are indicated by the “Controlled Copy” colored ink stamp at the bottom of each page. Procedures:

  3. Test methods and standard operating procedures are controlled documents with limited distribution. They are kept in three-ring binders. The Table of Contents includes all current and obsolete procedures assigned to a given work area and the following information:

  4. the code and title of each procedure
  5. the revision number of each procedure
  6. the effective date of each procedure
  7. review date – the date each procedure was last reviewed

  8. the status of each procedure (current or obsolete)

  9. Unique codes are assigned for each procedure.

  10. Test methods are written with the following headings:

  11. Scope

  12. Description of Test Items
  13. Holding Times
  14. Quantities to be Tested
  15. Materials and Equipment Required
  16. Physical Environmental Conditions Required
  17. Procedure
  18. Sample Identification
  19. Documentation
  20. Safety Measures
  21. Method for Data Analysis and Presentation
  22. Sensitivity
  23. Quality Control Plan
  24. Reference Procedures
  25. References
  26. Revision History

  27. Appendix

  28. SOPs are written with the following headings:

  29. Purpose

  30. Scope / Field of Application
  31. Definitions and Acronyms
  32. Responsibility
  33. Materials Required
  34. Procedure
  35. Documentation
  36. Reference Procedures
  37. References
  38. Revision History

  39. Appendix

  40. Procedures are peer-reviewed, authorized by management, copies uniquely identified, and distributed to users. Signatures indicate the approval of the procedure and the “Controlled Copy” colored ink stamp indicates document control is in effect for the procedure. Note – The issue date (see header) is the date the document was issued to the user for review. The effective date (see footer) is the date the document is effectively in place and followed.

  41. Obsolete master copies are clearly marked obsolete and archived for at least six years. All other draft copies and obsolete versions are destroyed to prevent inadvertent use.

  42. The Quality Manager and their deputies maintain the master copies of the most current procedures.

  43. The master list of procedures includes:

  44. code

  45. title
  46. revision number
  47. review date
  48. status (current, obsolete, or assigned)
  49. distribution list (copy number)

Document Review:

  1. Quality manual is reviewed annually by the Quality Manager. Records are kept of this review.

  2. Written procedures are reviewed on a biennial basis. The reviewer makes a record of this review, any required changes, and forwards to the Quality Manager. Document Changes/Revisions:

  3. Changes to the Quality Manual or a procedure require the same review and approval that performed the original review and approval.

  4. Changes are indicated by a vertical line in the left-hand margin adjacent to the revised area. The master index is updated to reflect the changes in revision status and revision release date.

  5. Personnel affected by the issue of a revised procedure are informed in writing. Revised procedures are distributed for training purposes leading up to effective date. Holders of obsolete copies return them to the Quality Manager and place the replacement into the manual.

  6. An index of obsolete quality manual sections and procedures is maintained. Amendments by Hand:

  7. Where permitted, hand written amendments are clearly marked, initialed, and dated on all copies. Computerized Documents:

  8. Electronic copies of documents are maintained under the authority of the Quality Manager.

  9. Access to electronic copies is password protected.
  10. Documents that are revised are maintained in a folder identified as current; the obsolete version is moved to a folder identified as obsolete. Documentation Revisions to Quality Manual sections and procedures are accompanied by a transmittal notice, which details the appropriate additions, removals, and replacements. Required Record Custodian Approved master copies of Quality Manual and procedures Quality Manager Controlled hard copies of Quality Manual and procedures As assigned Master list Quality Manager Document reviews Quality Manager Transmittal Notices Quality Manager Reference Procedures Templates for writing SOPs and test methods.