Auditee Rights/Audit Reporting
Name 3 things included in the introductory paragraph of an audit report.
Background/History, Name of auditee, Name of auditing organization/names of the audit team, Purpose of the audit, Scope of the audit, Dates the audit was performed, Location of the audit, Statement of the tone of the audit, List of findings, Requests for corrective actions, Signature by lead auditor.
Bonus 50 points: Name two positive and two negative descriptors of audit tone.
As lead auditor, what should you do after recording information to ensure it is complete and accurate?
Read it aloud
What is the title of 21CFR Part 830?
Unique Device Identification (UDI)
What is the title of 21CFR Part 821?
Medical Device Tracking Requirements
Bonus 50 points: What is the title of 21CFR Part 820?
The determination by the audit team of security concerns permits, plant layout detail, and travel arrangements are referred to as audit:
a. Logistics
b. Performance
c. Strategy
d. Checklists
a. Logistics
Items in the question content as well as meeting areas, needed safety equipment, required escorts, etc. refer to audit logistics
Name a consequence of a late or procrastinated audit report.
A late report decreases the significance, priority, and interest of the formal audit report's corrective actions.
What prevents:
Blame of individuals rather than systems
Defensive behavior of individuals and arguments against findings
An impersonal report.
What are the two forms a UDI must appear in on every device label and package?
Easily readable plaintext and automatic identification and data capture technology (AIDC)
True or False:
In the eyes of the FDA, kit or system assemblers are not considered to be distributors.
False, kit or system assemblers are considered distributors.
Bonus 50 points: What do these distributors need to notify receivers of a kit or system about?
The audit report should include:
a. A summary of audit results and findings
b. Details of how the audit team was selected
c. Identification of person(s) who prepared the checklists
d. Qualifications of personnel who performed the audit
a. A summary of audit results and findings
The purpose of the audit report is to document the summarized results of the audit and findings.
True or false:
Auditees are inherently obligated to honor requests for corrective actions, but are not obligated to incorporate recommendations from auditors.
False, auditees are not obligated to honor requests for corrective actions nor incorporate recommendations (unless specified in their associated contract).
Why would the draft report be presented verbally? Why physically?
Verbally: more engaging
Physically: if the report is negative, the physical report is a place to divert your eyes
What is a UDI made up of? (2 parts)
Device identifier (DI) and production identifier (PI)
Bonus 50 points: What is the other common name of the DI?
21CFR Part 820 includes requirements related to methods used in, and facilities and controls for:
Name 2 of the 7 things.
Design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices for human use.
What individual determines the distribution list of the final audit report?
a. The auditing manager
b. The auditee chief executive officer
c. The audit client
d. The lead auditor
c. The audit client
Answers a and b are weak choices. The lead auditor (selection d) is responsible for the completion of the audit report. The lead auditor sends the audit report to the client, who is responsible for providing the auditee's senior management with a copy. The client ultimately decides the distribution list.
Marie is writing her audit report. When she was participating in the audit, she saw a hairball in the cleanroom. She marked this down as an observation during the audit, but now thinking back she thinks this definitely should have been a finding.
Should Marie change the observation to a finding in the report?
No! It is unethical to alter the substance of the audit report after the audit.
Marie could be remembering wrong!
She should have escalated this further during the audit, and she can check for this next audit to see if the issue has improved. She will have a chance to issue the finding then.
Name the two benefits of presenting a draft report to the auditee.
Keeps the auditor honest when preparing the final report, limiting the pressure to change it
Provides the auditee with a heads up to begin determining corrective actions
What is a permanent UDI?
Required for devices that are intended to be used more than once with reprocessing before each use (should be on the actual device itself)
3 working days for devices that have not been distributed
10 working days for devices that have been distributed to patients
Auditing of a quality program is most effective on a:
a. Quarterly basis, auditing all characteristics on the checklist
b. Periodic unscheduled basis, auditing some of the procedures
c. Continuing basis, auditing randomly selected procedures
d. Continually specified time period basis, frequency adjustable, auditing randomly selected procedures
d. Continually specified time period basis, frequency adjustable, auditing randomly selected procedures
The key question phrase is "most effective". There is some learning built into this question.
a. False. There is no universal reason that audits must be quarterly
b. False. Auditing should be scheduled.
c. False. What does continuing mean?
d. True. This is the best choice of the group. The time element is addressed properly.
Name the four pressures/complications an audit report can face.
From the audited organization
From the auditee
From political pressures
Product-related pressure
When using a scoring checklist, what should be added to the daily audit briefings?
What are the requirements for an issuing agency to be accredited by the FDA?
Conform with ISO standards listed with requirements for UDI
Be available to users with consistent, fair, and reasonable terms/conditions
Protect against conflict of interest between the issuing agency and labeler
What are the three circumstances in which a medical device is required to be tracked?
Their failure is reasonably likely to have serious, adverse health consequences
They are intended to be implanted in the human body for more than one year
They are life sustaining or life supporting devices used outside of a device user facility
Why should an auditor avoid giving unsolicited recommendations for corrective action?
a. Auditee management is responsible for determining and taking effective corrective action
b. The auditor may be billed for unsolicited recommendations which hinder production
c. The auditor's job is to obtain as many findings as possible, not to give advice
d. The auditor will look bad if the recommendation is wrong
a. Auditee management is responsible for determining and taking effective corrective action
It is never advisable to give a "recommendation", whether it is solicited or unsolicited. This question asks "Why"? Giving a recommendation is taking responsibility for the problem.