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.

functionality for data processing shall be protected against inadvertent or unauthorized change.

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8

Management system requirements

8.2

Management system documentation (Option A)

8.2.1 The management systems can be incorporated into a quality manual for a multifunctional laboratory, but specific sections pertaining to special needs for various analytes and/or techniques shall be easily identifiable. There may be specific subsections for various analytes included in the document.

8.4

Control of records (Option A)

8.4.2 Method validation and verification records shall be retained, at a minimum, for as long as the method is in use by the laboratory and adheres to the laboratory’s policy on document retention.

The laboratory shall have a procedure to periodically confirm access to backup records. There shall be a record of these periodic confirmations. Backup records shall be stored in a separate location from the original records.

8.5

Actions to address risks and opportunities (Option A)

8.5.1

8.5.2 b)

Note: The laboratory’s evaluation of effectiveness should include whether the actions created new problems.

Note: The effectiveness of actions may be reviewed and monitored during management review and/or scheduled internal audits.

8 .7 Corrective action (Option A)

8.7.1.

Note: It can be tempting to short-cut the cause analysis. Restating the problem as the cause is not appropriate nor is assuming a single underlying cause before completion of the analysis.

1. To Identify Possible Causal Factors you need to consider:

Physical causes – Tangible, material items failed in some way.

Human causes – People did something wrong, or did not do something that was needed.

Organizational causes – A system, process, or policy that people use to make decisions or do their work is faulty

2. Ask Why repeatedly until the Cause is identified

08/09/2018