Good Documentation Practices in Quality Assurance

Good Documentation Practices in Quality Assurance

• 1.
  Lecture 6 Good DocumentationPractice
• 2.
  What is GoodDocumentation Practice?
• 3.
  Purpose of LaboratoryDocumentation
• 5.
  What constitutes GoodDocumentation Legible: everyone should be able to read what is written regardless of who, where or what has been written. Concise: the document must provide clear information that is understood by all customers Traceable: who recorded it, where and why Contemporaneous: the information should be documented at the correct time frame along with flow of events Enduring: Long lasting and durable Accessible: Easily available for review.
• 6.
  Documentation Process inthe Laboratory • Document creation and approval • Document use and data collection • Document maintenance and verification • Record Review • Record Modification and Correction • Record Archiving • Record Destruction
• 7.
  Common Documentation Errors Missingsignature and dates at the time of activity performed.  The write-over  Non-uniform date and signature entry  Writing a note that activity was performed on one day and signed for on other day.  Blank spaces Illegible writing Too many corrections
• 8.
  Principles of GoodDocumentation Practice • A document bearing original signatures should never be destroyed. • Never falsify information • Never White-out and cover-over-tapes • Never demolish information or record • Never over-write a record. • Never use pencil – all information should be completed in permanent Black or Blue ink • No spaces, lines or fields are to be left blank • Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive
• 9.
  Benefits of GoodDocumentation Practice • Build confidence in the Laboratory Quality System • Reduce efforts to compliance with regulatory bodies • Allows for achievements of required results. • Correct, complete, current and consistent information effectively meets customers and stakeholders' requirements • Enables the Laboratory activities to be arranged into functional patterns for specific action. • Create structures so that staff can systematically coordinate to conduct business. • Training of Laboratory staff. • Solve complicated problems • Reduce or eliminate assumptions and second-guessing.
• 10.
  Benefits of GoodDocumentation Practice • Eliminate the need to re-ask the same questions • Specify clear instructions for staff