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Draft 6. Note: This document is a draft suggestion only and is not an approved document.
Please do not distribute to laboratory staff for use.
4.13.2.1
Quality-critical reagents prepared in the laboratory shall be labeled and the preparation recorded to identify
substance, strength, solvent (where not water), any special precautions or hazards, restrictions of use, and date of
preparation and/or expiration. The person responsible for the preparation of the reagent shall be traceable through the
information on both the label and in the records.
The requirement for an audit trail in laboratory records applies to:
(a) sample receipt (check-in)
(b) sample preparation
(c) sample handling and storage
(d) sample analysis
(e) equipment qualification and maintenance
(f) equipment performance
(e.g., using Certified Reference Materials [CRMs], proficiency checks, and
daily checks)
(g) calibration records
with traceability to CRMs
(h) traceability to each analyst performing steps in the testing process
(i) analyst training
with traceability to RMs and proficiency checks
(j) results
(k) reviews
(l) reports (mailed reports, faxes)
(m) review of electronic transmissions (e.g., Laboratory Information Management Systems [LIMS]
acquisitions)
(n) proficiency test results
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 or on
a space on a form or LIMS entry.
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.
4.13.2.3
All alterations to records shall also include the date(s) of the change.
4.14 Internal Audits
4.14.1
Internal audit programs should include both horizontal and vertical investigations. Horizontal audits examine
a particular management system requirement, activity, or process in detail, e.g. across multiple samples, persons,
equipment, departments, etc. Vertical audits trace a single sample through all aspects of handling, e.g. from sample
receipt to data reporting.
4.15 Management Reviews
4.15.1
The records for management review shall identify the top management responsible for and conducting the
management review process.
5. Technical Requirements
5.2 Personnel
5.2.1
The laboratory shall have procedures for defining the initial and ongoing competency of all personnel.
Personnel shall have demonstrated their competency prior to working on customer samples.
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