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: Staff conducting investigations should not be accusatory in their questioning so as to avoid finger-pointing and unproductive behaviors. Keep in mind most sources of nonconformance will come from poor process, not poor performance.

3. Once a Cause has been identified, Take Corrective Action

Decide what can you do to prevent the problem from happening again?

Determine how the solution will be implemented

Define who will be responsible for implementation

Evaluate the risks of implementing the solution

4. Verify the effectiveness of the corrective action

8.8

Internal audits (Option A)

8.8.1 Internal audits of laboratory information management systems shall be conducted at least once per accreditation cycle.

Note: Internal audit programs should include both horizontal and vertical investigations of all elements. 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.

Pre-Accreditation: Internal audits shall be completed for all parts of the quality system for which the laboratory wants to become accredited.

8.8.2 a)

Frequency and scopes of audits shall be planned on risk-based assessments.

8.9

Management reviews (Option A)

8.9.1 Management review shall include a review of non-conforming work for trends. Also customer and personnel feedback and complaints shall be reviewed for trends

8.9.2 a) …

Note: This can include: staffing, regulations, nature of customer base and industry trends. Look for things that could change the course of the business and thereby the quality system.

8.9.2 m)

8.9.2 n) Note : This review shall include a review of proficiency test results

08/09/2018