Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Note: Examples of communication processes are signed staff acknowledgements of minutes of regularly scheduled meetings, the management review, memoranda, etc.

6

Resource requirements

6.2

Personnel

6.2.2 In cases where staff is qualified on only a portion of a method, the training records shall indicate those parts upon which they have been trained.

NOTE: It is recommended that the procedure contain the following elements:

 Provide due consideration to different experience/education levels of staff and how that could influence the degree of training  Consider if/how staff might be deemed competent based on previous experience or education  Have a mechanism by which bench staff are objectively assessed on competence such as: o Testing a proficiency sample o Testing a well-characterized laboratory control sample o Comparison of results against other trained staff o Comparison of results against other established methodology/technology  Define re-qualification of staff that have not performed a procedure/method for extended periods Note: It is recommended that laboratories establish a training matrix to track the training status of employees. This has benefits in highlighting key staff (those singularly trained on a task or method), tracking training progress, ensuring proper coverage for laboratory activities, and facilitating employee development. Depending on size and complexity of laboratory activities, this could be as simple as a spreadsheet or as complex as a formal learning management system. 6.2.3 For dietary supplements and pharmaceuticals, a qualified person must review complaints for possible failures and investigate where needed. The laboratory shall define qualifications of staff handling complaints . Note: Training on laboratory activities includes training on the quality management system.

6.3

Facilities and environmental conditions

6.3.3

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Note: The laboratory should practice good housekeeping at all times. This includes ensuring benches, equipment, and floors are clean before and after preparation/analytical activities to help ensure testing integrity. It is recommended that laboratories establish policies or procedures for this purpose and formally assign staff to the tasks . Note: Monitoring in a microbiology laboratory may include: environmental swabbing, hand swabbing, air monitoring for bacteria and mold, water testing, temperature monitoring and PCR amplicon swabbing. Monitoring in a chemistry laboratory may include: instrument room temperatures, humidity, room lighting, blank monitoring and water testing.

6.3.4 b)

Note: Prevention of contamination, interference or adverse influences on laboratory activities can include the use of impermeable work surfaces and chairs in testing areas, scheduled vector/pest inspections, prohibition of aerosols (e.g. cleansers, pesticides, etc.) that may contribute to contamination of samples, and pH testing of water used to

08/09/2018