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Laboratory Audits. Version 6.0, August 2012. Objectives. Define an audit and list four different types of audits List the types of audits associated with the Food and Drug Administration (FDA), Accreditation/Certification Body and Sponsor

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laboratory audits

Laboratory Audits

Version 6.0, August 2012

objectives
Objectives
  • Define an audit and list four different types of audits
  • List the types of audits associated with the Food and Drug Administration (FDA), Accreditation/Certification Body and Sponsor
  • List and explain the steps involved in conducting a Division of Acquired Immunodeficiency Syndrome (DAIDS) audit
  • Describe how to manage and prepare for an audit
pre assessment question 1
Pre-Assessment Question #1

Do auditors always provide advance notice prior to audit visits?

  • Yes
  • No
pre assessment question 2
Pre-Assessment Question #2

Audits by College of American Pathologists (CAP) would be considered:

  • Regulatory audits
  • Accrediting body audits
  • Internal audits
  • Sponsor audits
pre assessment question 3
Pre-Assessment Question #3

Which of the following is not a typical step in the DAIDS audit process?

  • Send pre-visit letter and audit checklist 5 days prior to the audit
  • Conduct an opening meeting to review audit agenda
  • Visit the laboratory and observe operational procedures
  • Debrief the laboratory on audit findings
pre assessment question 4
Pre-Assessment Question #4

In preparation for an FDA audit, laboratory staff should:

  • Designate a staff member to accompany the auditor at all times
  • Review the audit agenda to determine the scope
  • Notify DAIDS and clinic staff
  • Make copies and label documents appropriately
  • All of the above
definitions

An examination of records to check their accuracy

An examination of records to check their accuracy

  • The act of assessing; appraisal

Audit

Assessment

Definitions

The act of inspecting; official examination or review

Inspection

types of audits

Regulatory Audits

Types of Audits

Accrediting Body Audits

Internal Audits

Sponsor Audits

fda audits
FDA Audits

For-Cause Audit

Targeted Audit

FDA

Whistle Blower

Unpredictable Frequency

Guidelines

accreditation certification body audits
Accreditation/Certification Body Audits

Accreditation Requirements

Certification Requirements

Accreditation/Certification Body

Possible Advanced Notice

Guidelines Available Online

sponsor audits
Sponsor Audits

Facility Operation

Check for GCLP Compliance

Sponsor

Scheduling Flexibility

Advanced Notice

Guidelines

sponsor audits cont d
Sponsor Audits (cont’d)

1. Receive Request

2. Schedule Visit

3. Send Pre Visit Letter (PVL)

Conducting the Audit

4. Opening Meeting

5. Gather Evidence

6. Record Findings

7. Debrief

8. Audit Report

notify all appropriate persons
Notify All Appropriate Persons

Other Staff

DAIDS

Laboratory Staff

FDA Audit

determine the scope
Determine the Scope
  • Most agencies will give advanced notice
  • If an agenda is provided, review it, and plan carefully
be prepared
Be Prepared!

Once an audit is scheduled, you will already be prepared…

RIGHT?

But, what does that mean?

length of audit

Unpredictable

  • Approximately two days

FDA Audit

Accrediting Agency Audit

Length of Audit

Approximately two days

Sponsor Audit

slide20

Designate a staff member to accompany the auditor at all times.

Tips

Create a file for the audit and make a duplicate copy for your file.

Answer the auditor’s queries with clear, concise answers. Don’t over do it.

Make copies and label documents appropriately.

tips cont d

Ask follow-up questions. Example: “Is that what you were looking for?”

Tips (cont’d)

Present questions to the auditor and clarify other issues raised.

Insist on a debriefing or summation.

Make sure you understand what the auditor is requesting.

the audit report
The Audit Report

Have I reviewed it carefully?

Is it accurate?

Laboratory

Audit

Report

audits
Audits

What are the negatives?

What are the positives?

post assessment question 1
Post-Assessment Question #1

Do auditors always provide advance notice prior to audit visits?

  • Yes
  • No
post assessment question 2
Post-Assessment Question #2

Audits by CAP would be considered:

  • Regulatory audits
  • Accrediting body audits
  • Internal audits
  • Sponsor audits
post assessment question 3
Post-Assessment Question #3

Which of the following is not a typical step in the DAIDS audit process?

  • Send pre-visit letter and audit checklist 5 days prior to the audit
  • Conduct an opening meeting to review audit agenda
  • Visit the laboratory and observe operational procedures
  • Debrief the laboratory on audit findings
post assessment question 4
Post-Assessment Question #4

In preparation for an FDA audit, laboratory staff should:

  • Designate a staff member to accompany the auditor at all times
  • Review the audit agenda to determine the scope
  • Notify DAIDS and clinic staff
  • Make copies and label documents appropriately
  • All of the above
references resources
References/Resources
  • DAIDS Laboratory Audit Process
  • Introduction to the US FDA Inspection Process
    • (DAIDS LMS course 1230)

https://daidslms.plateau.com/learning/user/login