4- Documents and Records.Why do laboratories need to manage documents and records?
- 3. 3 Why do laboratories need to manage documents and records? To find information whenever it is needed!
- 4. 4 Documents and Records—How do they differ? Documents communicate information via policies, processes, and procedures need updating Records capture information on worksheets, forms, labels, and charts permanent, do not change RECORDS
- 5. 5 Information is the major product of the laboratory
- 7. 7 Policies - The “WHAT TO DO” “A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” Policies: tell “what to do” in a broad and general way include the organizational mission, goals, and purpose serve as the framework for the quality system should always be specified in the quality manual
- 8. 8 Processes - The “HOW IT HAPPENS” A “set of interrelated or interacting activities that transform inputs into outputs.” Processes: describe the steps involved to carry out quality policies easily represented in flow charts involve a series of steps, usually occurring over a period of time
- 9. 9 Procedures - The “HOW TO DO IT” Standard operating procedures (SOP) step-by-step instructions for performing a single activity Job aid a shortened version of the SOP does not replace the SOP
- 10. 10 Hierarchy of Documents “How to do it” “How it happens” “What to do”
- 11. 11 Why are documents important? essential guidelines for laboratory quality manual SOPs reference materials required by formal laboratory standards
- 12. 12 Documents are the communicators of the quality management system Verbal instructions often are: not heard misunderstood quickly forgotten difficult to follow
- 13. 13 Documents are a reflection of the laboratory’s organization and its quality management. A good rule to follow is: “Do what you wrote and write what you are doing.”
- 14. 14 Good Documents are: clear concise user-friendly Obvious accurate up-to-date
- 15. 15 Documents for work processes should be accessible to staff at the work site : instructions on handling incoming samples SOPs for each test quality control charts and trouble-shooting instructions safety manuals and precautions
- 16. 16 The Quality Manual is a document describing the quality management system of an organization
- 17. 17 Quality Manual communicates information serves as a framework or roadmap for meeting quality management system requirements demonstrates management commitment to quality
- 18. 18 Writing a Quality Manual
- 19. 19 Writing a Quality Manual Form a Steering Committee Set policy for 12 QS essentials Describe how the related quality processes occur Reference procedures
- 20. 20 Key Points: Quality Manual only ONE official version never “done”, always being improved read and accepted by everyone use the best-adapted language Very big job, but very useful
- 21. 21 Standard Operating Procedures (SOPs) are documents that: describe how to perform a test using step-by-step instructions written SOPs help ensure: consistency accuracy quality
- 22. 22 A Good SOP provides detailed, clear, and concise direction for testing techniques is easily understood by new personnel is reviewed and approved by management is updated on a regular basis
- 23. 23 Standardized SOP Format Computerized procedure Standardization: Header Version/chapter/reference Author/reader/validator Recipients Version date/Application date Typical outline Updating and storage of different versions is easy J Johnson, RB Smith
- 24. 24 Complete Standardized Header Use at the top of the first page only
- 25. 25 Reduced Standardized Header other pages of every procedure use at the top of all other pages
- 26. 26 When Preparing SOPs establish means for updating gather all documents include each step assess scientific validity determine procedure to use
- 27. 27 Suggested Outline for SOPs Title: Name of Test Purpose: Medical use Instructions: Preexamination Examination Postexamination References to verify the method is established Author’s name Approval signature(s)–initial and date
- 28. 28 Avoid Drowning in Detail….. BAD EXAMPLE: “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”…
- 29. 29 Do not rely solely on manufacturer product inserts Inserts do not provide specific information for test sites, such as: materials required, but not in kit specific safety requirements external quality control requirements
- 30. 30 Job Aids shortened version of SOPs hand written or printed visible location at testing site useful tool to assure all testing steps are correctly performed
- 31. 31 Job Aids
- 32. 32 Job Aids
- 33. 33 Document Control assures that the most current version is used ensures availability when needed organizational tool
- 34. 34 Document Control Elements system for organizing, such as numbering or coding system approval, distribution, and revision process master log that describes which documents are in circulation accessibility of documents at the point of use system for archiving
- 36. 36 Documents of External Origin Include in the laboratory document control system: instrument service manuals industry regulations ISO standards references used for documentation
- 37. 37 Numbering System need uniform numbering system do not change a current system that works one system: letter for the type of document and then an incremented number: B1, B2, B3 for books and T1, T2 for official texts number all pages of document reference by document code, pages, location code: Book number 2, pages 188- 200, on bookshelf 1: B2,188-200, BS1
- 38. 38 Document Preparation and Control Process Preparation Preparation Review Review Issue Issue Distribution Distribution Revision Revision Approval Approval
- 39. 39 Implementing Document Control collect existing documents and records review and update determine additional needs develop or obtain documents, forms, worksheets, logbooks, reports involve stakeholders
- 40. 40 Common Document Control Problems outdated documents too many documents are distributed and the system cannot be maintained lack of control of documents of external and internal origin
- 41. 41 Why are records essential? Sample tracking throughout process Management tool Identify problems Continuous monitoring of quality system
- 42. 42 Patient test reports EQA / PT records Quality control data Maintenance records Instrument printouts Workbooks Worksheets Sample log book or register Laboratory Records
- 44. 44 Keep the Things You Might Forget! disposition of rejected samples referral of samples to another laboratory records of adverse occurrences or problems inventory and storage records equipment purchase data, preventive maintenance, and troubleshooting
- 45. 45 Test Report Contents test identification laboratory identification patient unique identification and location name and address of requestor date and time of collection time of receipt in lab date and time of release of report primary sample type results (SI units) biological reference intervals interpretive comments person authorizing release, with signature when possible note if reporting a corrected result
- 46. 46 Paper Systems Permanence bind books number pages use permanent ink control storage Accessibility use system that will allow ease of access Security maintain confidentiality keep safe from environmental hazards Traceability allow for tracking of a specimen throughout all processes
- 47. 47
- 48. 48 Electronic Systems permanence computer system maintenance, backups security access confidentiality traceability
- 50. 50 Summary Documents: include written policies, processes, and procedures need to be updated and maintained Records: include information captured in processes are permanent, do not require updating A good document control program: most current version used availability and ease of access
- 51. 51 Key Messages Information is our product. Documents are essential for assuring accuracy and consistency in the laboratory.
- 52. 52 Scenario testing algorithm safety manual client test results standard operation procedures (SOPs) for an approved HIV rapid test manufacturer test kit inserts summary of findings from on-site evaluation visit report of corrective actions temperature log (blank form) quality control record (blank form) daily maintenance log (completed) stock cards and stock book (completed) EQA sample transfer log (completed) You have found all these papers lying on a desk. Which of these are documents and which are records?
- 53. 53 Scenario testing algorithm safety manual client test results standard operation procedures (SOPs) for an approved HIV rapid test manufacturer test kit inserts summary of findings from on-site evaluation visit report of corrective actions temperature log (blank form) quality control record (blank form) daily maintenance log (completed) stock cards and stock book (completed) EQA sample transfer log (completed) You have found all these papers lying on a desk. Which of these are documents and which are records?
- 54. 54 Questions? Comments? Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety