Form 0920-0109 NIOSH CORRECTIVE ACTION REQUEST (CAR) Form

Form Approved

OMB No. 0920-0109

Exp. Date xx/xx/20xx

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. Immediate correction of the nonconformance Root cause or investigation of the nonconformance Correction of all outcomes of the root cause/investigation (e.g., other documents affected, product affected) 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.

Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for reviewing instruction, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSD Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0109).