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Att 7c_Site audits,Site audits (completed for each corrective action)
ICR 202311-0920-004 · OMB 0920-0109 · Object 136983800.
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | Att 7c_Site audits,Site audits (completed for each corrective action) |
| Author | Greenawald, Lee (CDC/NIOSH/NPPTL/ETB) |
| Last Modified By | Writer |
| File Modified | 2023-10-26 |
| File Created | 2026-10-02 |
| Conversion State | complete |
Extracted Text
NIOSH CORRECTIVE ACTION REQUEST (CAR) Form
Approval Holder: Click or tap here to enter text.
NIOSH Reference: Click or tap here to enter text.
CAR Number: Click or tap here to enter text.
Audit Report Date: Click or tap to enter a date.
This Form is Due By: Click or tap to enter a date.
Description of Nonconformance:
Corrective Action/Response by Approval Holder
Your response should include information on some or all of the following, as applicable.
1. Immediate correction of the nonconformance
2. Root cause or investigation of the nonconformance
3. Correction of all outcomes of the root cause/investigation (e.g., other documents affected, product affected)
4. Action(s) required to prevent the reoccurrence of similar non-conformances
NIOSH Response
(Brief Description of the resolution) Example: In response to the balance calibration certificate having two values out of tolerance (OOT), company A contacted their calibration provider to ensure a notification is provided whenever a device is found OOT. Furthermore, company A added a second review to their calibration certificate performed by the QM. Both reviews must be completed prior to the certificate being added to the system. Finally company A evaluated the impact of the OOT and found that no testing was affected. Evidence provided includes training records, the updated SOP 0101 calibration SOP, and the nonconforming equipment report.
NIOSH has reviewed this response, and accepts the Approval Holder’s response to the CAR and planned actions to resolve the CAR. This corrective action will be verified at the next site audit.
An application is required to resolve this CAR. Submit this CAR form and reference this TN and CAR # when submitting the application. Only responses to this CAR should be the reason for application. If additional changes to the approval are made that are not relevant to this CAR, the application will be denied.
Submitted By: Click or tap here to enter text.
Date: Click or tap to enter a date.
NIOSH Reviewer: Click or tap here to enter text.
Date: Click or tap to enter a date.