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.

7.5

Technical records

7.5.1

The requirement for an audit trail in laboratory records includes:

(a) Analyst(s) performing steps in the testing process (see note) (b) Analyst training  with traceability to RMs and proficiency checks (c) Calibration records  with traceability to suitable Reference Materials (d) Column lot number (e) Equipment performance  (e.g., using Certified Reference Materials [CRMs], proficiency checks, and daily checks) (f) Equipment qualification and maintenance (g) Equipment used (see Note) (h) Media/Reagent identity (i) Media/Reagent open date when open date impacts expiration date (j) Media/Reagent/Reference material expiration date (k) Media/Reagent/Reference material laboratory assigned identification

(l) Media/Reagent/Reference material lot number (m) Media/Reagent/Reference material received date (n) Prepared media/reagent preparation date

(o) Prepared media/reagent preparer (p) Prepared reagent components (q) Prepared reagent special instruction, hazards, or use restrictions

(r) Reagent concentration/purity (s) Reports (mailed or electronic,) (t) Results (u) Review of electronic transmissions (e.g., Laboratory Information Management Systems [LIMS] acquisitions) (v) Reviews (w) Sample analysis (raw data including chromatograms, standard curves, etc.) (x) Sample handling and storage (y) Sample preparation (z) Sample receipt (log-in/check-in)

If a method allows multiple testing options, then the laboratory record shall document which option was followed. The option selected could be recorded many ways, such as including the information in a laboratory work instruction, form, or LIMS entry.

Where strict chain-of-custody is requested by the customer (e.g., samples used in litigation or otherwise required by law), the laboratory shall have a policy and procedure for it.

Note: The independent system to collect the data can vary from manually recording the times to using electronic recording of the time such as high-performance liquid chromatography (HPLC) electronic files, printouts or chart recordings. Also, for systems that are automatically controlled, it may be adequate to periodically verify the automatic control. However, if the verification fails, all runs since the most recent successful verification are suspect. An example of such an automatic control is an autoclave. Note: Some steps may be performed by groups of people or involve groups of equipment (such as pipettes or balances). Laboratories may trace records to groups of people/equipment if the individual staff and/or equipment IDs are defined. This mechanism for establishing traceability has drawbacks. If a problem is found with any individual person or individual equipment, then all data that went through that group is at risk.

7.5.2

08/09/2018