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Date: 05/28/08

To: (Who)

From: (Who)

Subject: Internal Audit (Report number)

During WW19 and WW20, FY2007, audit interviews and a bench audit were conducted of
Calibration. The audit focused on adherence to process, traceability, training, environmental
controls, records and corrective action.
# of Checklist Elements Reviewed: 28
# of Discrepancies Noted: 1
# of Observations Noted: 0
The ‘Discrepancy’ noted during the audit is summarized in the attached ‘Corrective
Action Request/Tracking Form’.
- We need a corrective action response on the attached ‘Corrective Action
Request/Tracking Form’' by (Date). If you need more time, call me!
- The response needs to describe:
o The root cause of the problem
o What’s going to be done to fix it
o Who is going to do it
o When will the fix be in place

We’ll need evidence that you’ve implemented the corrective action 5 working days after
the date you indicated the fix would be in place.
If we don’t get a corrective action response, or if you fail to provide evidence that the
corrective action has been implemented, the audit report will go to your supervisor or
manager for him to correct the problem.

CC: (Who)

(Audit report number) Page 1 of 3

Attachments: Summary, Tracking form

Page 2 of 3

During WW19 and WW20, FY2007, audit interviews and a bench audit were conducted of Calibration. The
audit focused on:

• Environmental controls;
• calibration process definition and application;
• two-way communications;
• error-proofing aspects and process improvements;
• means and tools for operators to ensure requirements are met;
• oversight of contracted cal labs;
• training.

1. The A2L2 web site shows recently updated information on calibration contractors, including
certification to ISO 17025.

2. Records of temperature/humidity and certificates for standards were available for the time frame called
out in (document).

3. ESD controls have been reviewed by the corporate ESD Director. ESD safe tiles have been installed;
when more information on requirements comes in, arrangements will be made to make more upgrades
as needed.

4. Certificates and environmental records are physically protected with a fire protection system, and a lock
has been installed on the door to protect them from tampering.

Opportunity for Improvement:

1. Two equipment techs were found to not have certification to (process). It was decided they need the cert
although there was no record of their having done calibrations in the past year. The Cal Lab manager
could work more closely with group managers to look over the departmental training matrices and make
plans for certifying people before the need comes up.

Scope: TS-16949, Quality Manual, Process document numbers)

Last audit: (Report #), no CAR

Copy of CAR