Objective:

Scope:

Responsibilities

A. QA Officer

• Verifies adequacy and accuracy of forms and worksheets used in the area
• Reviews report packets for completeness
• Ensures employees are trained in record keeping
• Responsible for using the proper and approved forms and worksheets,
• Responsible for following record management guidelines, and
• Securing records (i.e. placing in locked cabinets) when in their possession.

B. Sr. QA Officer

• Implements record management system in respective branch
• Ensures proper forms and worksheets are used in respective departments

C. Assistant Manager QA

• Ensures implementation of a record management system
• Ensures storage areas for records are within resources
• Periodically assess the effectiveness of the record management system.

D. Manager Quality Assurance (MQA):

• Maintains record system for quality records
• Archives and disposes of quality records as established by record schedule.
• Background None
• References Staff Manual Guide FDA 2460, Management Programs, Records Management.

Procedure illustrated is as follows:

1. When non-conformity is detected suspend work and evaluate the situation. Take action to identify non-conformance. Obtain Corrective Action and Problem Report (CAPR) form.
2. Complete the first section on the CAPR form.
3. Begin investigation to resolve the problem by examining the extent of the problem.
4. Note findings and causes with supporting evidence. Complete next section of CAPR form.
5. Decide action to be taken. Perform corrective action. Complete the next section of the CAPR form.
6. Submit CAPR form to immediate supervisor and QMS Manager for review and approval. The supervisor will review and perform one of the following actions:
7. Not approve the actions taken and recommend further actions to be taken. Additional corrective action will be implemented, reviewed and approved.
8. Approve the corrective action and enter in name and date on form, release the product and submit the CAPR form and supporting documentation to the QMS Manager within 30 days of date action initiated.
9. The QMS Manager reviews, evaluates and determines effectiveness of actions taken. The process may be approved and closed or further follow up actions may be identified and returned, or determined to be ineffective, and a corrective action process initiated to correct non- conformity.

Flowchart FLOWCHART – Corrective Action

• Follow-Up & Assign New Date
• Not Effective
• Approved
• Not Approved
• Approves or Not Approves
• CLOSED
• PRODUCT RELEASE
• DECIDE ACTION TO TAKE
• CAPR
• NONCONFORMITY DETECTED Work suspended and evaluated

Corrective Action

A. Accountability for Corrective Actions

1. The QMS Manager serves as the focal point for data quality, instrument problems, report and action quality and for feedback on district operations and corrective actions taken.
2. Corrective action at the technical level is initiated and corrected by the analyst, technician, officer or supervisor. The person who created the problem, fixes it.
3. The QMS Manager detects and corrects systematic problems which may occur in the course of daily work by maintaining surveillance over stated quality objectives and requirements, audits, and complaints.
4. The CAPR form is located on the [Location]. A sequential number will be assigned by the QMS Manager and serves as the tracking mechanism.

B. Initiation and Completion of Corrective Action

1. The investigation of suspected quality problems is initiated as a result of quality control criteria being exceeded, specified requirements not being met, audit findings indicating systematic problems, or as a result of a complaint.
2. Corrective actions are of two kinds:
3. On-the-spot or immediate corrective action to correct or repair non-conforming data, reporting or equipment, that are actions routinely made by analysts, technicians and supervisors; and
4. A CAPR form is to report the non-conformity. This form provides the steps for a closed-loop process that includes:

• initiation and identification of nonconformity,
• investigation (examine extent),
• findings and conclusions,
• determination of cause to prevent reoccurrence,
• corrective action taken and implemented, and
• follow-up by the QMS Manager to ensure that the corrective action is a fix and succeeded in achieving the results desired and is effective.

• equipment failure;
• incomplete or nonexistent procedures;
• non-compliance with procedures and regulations;
• improper collection, storage, handling, or preparation;
• calculation errors or transcription errors; and
• lack of training.

• equipment repaired,
• procedures revised or created,
• proper training given.

Submission to QMS Manager and Follow-up:

1. Completed CAPRs with supporting documentation are submitted to the QMS Manager for filing within 30 days of date action initiated.
2. The QMS Manger reviews the form and evaluates the implementation and effectiveness of the corrective action (e.g. Are quality objectives met?).
3. If deemed necessary, follow-up actions will be identified and a new date for completion set and approved.
4. When there is objective evidence that the actions are completed and effective, the QMS Manager approves and closes the CAPR.
5. If the CAPR was initiated due to a complaint, the CAPR is not closed until the customers has been contacted and confirmed that their concerns have been met. See Section 1, ORA-LAB.4.8 Complaints.
6. The nature of the non-conformity and status of this process is reported to the District Director or Laboratory Director and Branch Directors monthly by the QMS Manager.

Product Release

1. Data, reports, and actions are not released until the problem is resolved and verified by the Supervisor or Branch Director. The sample may need to be reanalyzed or re-collected or the inspection redone. If unable to resolve the problem, the receiver is notified that the laboratory data cannot be reported or accepted, with disclaimers made that the product did not meet quality standards.
2. In the event that a non-conformity has been identified and previous reported data is suspect, the customer is notified and if possible, the product brought into limits by rework or reanalysis to confirm the validity of what was reported.
3. Corrective action – This is an endeavor taken to eliminate the causes of a Definitions detected non-conformance, defect or other undesirable situation in order to prevent reoccurrence.
4. Corrective action and problem report form – Form is used to initiate corrective action.
5. Non-conformance – This is non-fulfillment of a specified, or implied, requirement of the Quality management System or of a quality work product. Fitness-for-use criteria and evaluations determine the significance of a nonconformance.
6. Cause – A cause is a fundamental deficiency that results in a non-conformance and is to be corrected to prevent reoccurrence of the same, or similar, non-conformance.
7. Signature – A signature is a handwritten, electronically written, or electronically typed name of an individual or entity that indicates an act of approval, disapproval, review, or recommendation.