Formalizing Lab Procedures “Key Steps to Improving Quality Within the Lab” Brian Corrigan, PATLQ Paul Sauvé, CLS March 1

1. Formalizing Lab Procedures “Key Steps to Improving Quality Within the Lab” Brian Corrigan, PATLQ Paul Sauvé, CLS March 15, 2005 Lansing, Michigan

2. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”.

3. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are:

4. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies

5. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures

6. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms

7. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records

8. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records 5. Retention

9. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records 5. Retention 6. Retrieval

10. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records 5. Retention 6. Retrieval 7. Analysis

11. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records 5. Retention 6. Retrieval 7. Analysis 8. Response

12. This presentation will address nine key concepts which are critical to improving quality within a testing laboratory. These concepts follow one another in a logical sequence and form the basis of an effective “quality system”. The nine concepts which will be addressed are: 1. Policies 2. Procedures 3. Forms 4. Records 5. Retention 6. Retrieval 7. Analysis 8. Response 9. Revision

13. POLICIES: Every quality assurance or quality control activity should evolve from a policy. Policies are SHORT statements of intent which specify WHAT will be done not how it will be done.

14. POLICIES: Every quality assurance or quality control activity should evolve from a policy. Policies are SHORT statements of intent which specify WHAT will be done not how it will be done. Some policies are related to the administrative aspects of laboratory operation.

15. POLICIES: Every quality assurance or quality control activity should evolve from a policy. Policies are SHORT statements of intent which specify WHAT will be done not how it will be done. Some policies are related to the administrative aspects of laboratory operation. “XYZ Testing will hire competent employees and will provide appropriate technical training to all laboratory staff”

16. POLICIES: Every quality assurance or quality control activity should evolve from a policy. Policies are SHORT statements of intent which specify WHAT will be done not how it will be done. Some policies are related to the administrative aspects of laboratory operation. “XYZ Testing will hire competent employees and will provide appropriate technical training to all laboratory staff” Some policies are related to the technical aspects of laboratory operation.

17. POLICIES: Every quality assurance or quality control activity should evolve from a policy. Policies are SHORT statements of intent which specify WHAT will be done not how it will be done. Some policies are related to the administrative aspects of laboratory operation. “XYZ Testing will hire competent employees and will provide appropriate technical training to all laboratory staff” Some policies are related to the technical aspects of laboratory operation. “XYZ Testing will monitor the stability of infrared analyzers on an hourly basis during routine testing of all DHI client samples”

18. *************************** Policies should be documented! ***************************

19. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include:

20. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title;

21. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number;

22. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number; 3. a revision number and/or date;

23. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number; 3. a revision number and/or date; 4. a statement of authority (The Lab Manager is responsible for...”)

24. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number; 3. a revision number and/or date; 4. a statement of authority (The Lab Manager is responsible for...”) 5. a statement of the scope referencing appropriate policies;

25. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number; 3. a revision number and/or date; 4. a statement of authority (The Lab Manager is responsible for...”) 5. a statement of the scope referencing appropriate policies; 6. detailed steps for carrying out the task and for documenting the corresponding results;

26. PROCEDURES: A procedure is a written set of instructions which provides the specific details of how a policy will be implemented. Procedures should be documented in a standard format and available as a reference to all testing staff. Standard operating procedures (SOP’s) should include: 1. a title; 2. a procedure number; 3. a revision number and/or date; 4. a statement of authority (The Lab Manager is responsible for...”) 5. a statement of the scope referencing appropriate policies; 6. detailed steps for carrying out the task and for documenting the corresponding results; 7. an appropriate page numbering system to ensure that no information is missing or excluded.

27. One policy may result in several procedures.

28. One policy may result in several procedures. Policy: “XYZ Testing will monitor the stability of infrared analyzers on an hourly basis during routine testing of all DHI client samples”

29. One policy may result in several procedures. Policy: “XYZ Testing will monitor the stability of infrared analyzers on an hourly basis during routine testing of all DHI client samples” Resulting Procedures: SOP #131 - Hourly Pilot Sample Checks (IR) SOP #132 - Hourly Zero Checks and Zero Adjustments (IR)

30. Procedures ensure that all staff are performing key functions correctly.

31. Procedures ensure that all staff are performing key functions correctly. They are critical to appropriate training of laboratory staff.

32. Procedures ensure that all staff are performing key functions correctly. They are critical to appropriate training of laboratory staff. They can also be used to demonstrate competence to clients and to auditors.

33. SOP #132 Hourly Zero Checks and Zero Adjustments (IR) REVISION #002 February 15, 2005 Scope: Hourly zero checks and/or adjustments are performed in order to monitor the stability of infrared analyzers on an hourly basis during routine testing of all DHI client samples. Responsibility: All Instrument Operators are responsible for performing the hourly zero checks in accordance with the following procedure. - PAGE 1 OF 2 -

34. SOP #132 Hourly Zero Checks and Zero Adjustments (IR) REVISION #002 February 15, 2005 • Procedure: • Sealed vials of zero solution (0.1% TX-100 ref. SOP #119) are held in the 42C waterbaths until needed. • Immediately following the hourly pilot sample check (ref. SOP #131), one vial of zero solution is tested manually three times in succession. • The second two fat and protein results are averaged and the values are recorded in the appropriate fields on Form #17C. • If drift for either component exceeds +/- 0.03%, the zero is reset and the adjustment is noted by checking the appropriate box on Form #17C. • If drift for either component exceeds +/- 0.06%, testing is discontinued and the Lab Manager or Shift Supervisor is consulted. • - PAGE 2 OF 2 -

35. FORMS: Forms provide a standardized means of recording critical information. They ensure that all necessary data generated in the procedure is appropriately recorded.

36. FORMS: Forms provide a standardized means of recording critical information. They ensure that all necessary data generated in the procedure is appropriately recorded. Forms can either be hard copy documents (worksheet) or electronic documents (spreadsheet template).

37. FORMS: Forms provide a standardized means of recording critical information. They ensure that all necessary data generated in the procedure is appropriately recorded. Forms can either be hard copy documents (worksheet) or electronic documents (spreadsheet template). Like SOP’s, forms should be titled and numbered.

38. FORMS: Forms provide a standardized means of recording critical information. They ensure that all necessary data generated in the procedure is appropriately recorded. Forms can either be hard copy documents (worksheet) or electronic documents (spreadsheet template). Like SOP’s, forms should be titled and numbered. The laboratory should maintain a standard list of all current forms in use.

40. RECORDS: Completed forms become records.

41. RECORDS: Completed forms become records. Hand written records should be neat and recorded in ink not pencil. Errors should be stroked out with a single line and corrected.

42. RECORDS: Completed forms become records. Hand written records should be neat and recorded in ink not pencil. Errors should be stroked out with a single line and corrected. Electronic records should be verified by the operator and should be backed up regularly.

44. RETENTION: Records should be retained for a predetermined length of time which is suitable for the specific application.

45. RETENTION: Records should be retained for a predetermined length of time which is suitable for the specific application. Preservation of records, both hard copies and electronic data, is critical.

46. RETENTION: Records should be retained for a predetermined length of time which is suitable for the specific application. Preservation of records, both hard copies and electronic data, is critical. Procedures for identification, filing, storage, electronic back-up and disposal should be documented in SOP’s.

47. RETRIEVAL: Records should be stored and organized so as to be readily retrieved whenever necessary.

48. RETRIEVAL: Records should be stored and organized so as to be readily retrieved whenever necessary. THIS IS NOT GOOD ENOUGH!

49. ANALYSIS: Laboratory records are retained for a reason -- not just to satisfy the CDCB requirements or the auditor.

50. ANALYSIS: Laboratory records are retained for a reason -- not just to satisfy the CDCB requirements or the auditor. Records should be reviewed on a regular basis and, where appropriate, analyzed statistically to identify trends or potential problems.