COMPANY X SOP #REG-014: Corrective and Preventive Action Procedures

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Revision : R-12
Effective Date: 7/08/03 Attachments: 0

Written/Revised By: Date: Copies Distributed:

Director of Quality: Date:

Leadership Team Date:

1 Purpose
This procedure describes the process for handling corrective actions, as well as methods for pro-active
preventive actions.
2 References
2.1 REG-001 Institutional Animal Care and Use Committee
2.2 REG 014.2 Complaint and Customer Feedback
2.3 REG-014.3 Product Recall System
3 Definitions
3.1 CAR - Corrective Action Report
3.2 Corrective Action - The action taken to correct a non-conformance. Corrective action includes the
identification of the root cause and defines measures taken to prevent recurrence.
3.3 Deviation or Nonconformance – a state that occurs in a process, product or quality system when
specified requirements are not met.
3.4 Initiator - The individual who identifies a non-conformance and initiates a corrective action report.
3.5 Preventive Action - Proactive measures taken to prevent non-conformances.
3.6 CAR Champion - The individual responsible for determining and implementing the corrective action.
3.7 Root Cause - The underlying issue that has caused a non-conformance.
4 Responsibility
4.1 All COMPANY X personnel are responsible for generating a CAR or making an entry into a deviation log
when a non-conformance is identified.
4.2 The Director of Quality has overall responsibility for assuring adherence to this procedure.
4.3 The Corrective Action Coordinator is the Quality System Specialist or designee. The Quality Supervisor
(Assembly/Packaging) will assist the Corrective Action Coordinator for the Assembly/Packaging division.
4.4 Accounting will process all Insurable Events on form QA-208
4.5 The Leadership Team is responsible for the periodic review of corrective action trends and relevant
preventive actions.
5 Materials
5.1 Form QA-072 Corrective Action Request
5.2 Form QA-264 Process Deviation Log- Technical Error
5.3 Form QA-265 Equipment Deviation Log- Equipment Related
5.4 Form QA-273 Equipment Books Audit Checklist
5.5 Form QA-208 COMPANY Evaluation Report For Insurable Events
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6 Procedure
6.1 Customer complaints will be processed according to REG-014.2 (and REG-014.3 if appropriate).
6.2 The corrective and preventive action system shall assess the following sources of quality data to identify
existing and potential causes of nonconformances: assembly and packaging operations, sterilization
processes, laboratory testing activities, quality audit reports, quality records, calibration records, client
complaints, and returned product.
6.3 One of two methods shall be used for tracking non-conformances.
6.3.1 Deviation logs track process and equipment non-conformances. Deviations shall be recorded
in the appropriate log within 48 business hours of recognizing that a deviation has occurred.
These logs shall be used when::
6.3.1.1 The deviation itself is not demonstrating a trend
6.3.1.2 There is not an impact on the process which requires a documented investigation
6.3.1.3 A corrective action is not planned
6.3.1.4 Deviation logs may also be used to capture unusual or unexpected equipment
function, even in the absence of a deviation.
6.3.1.5 Each deviation shall be reviewed by supervisory personnel who will elevate the
deviation to a CAR if a trend becomes evident. If a CAR is initiated, the CAR # will
be included on the deviation log.
6.3.1.6 Process and equipment deviation logs will be used by the testing departments (Micro,
Tox, Chemistry), Contract Sterilization, Maintenance, Metrology, IT and Assembly
and Packaging.
6.3.1.7 QA shall audit a sampling of deviation logs as part of the bi-monthly Equipment Book
audits to help ensure identification of deviation trends. Audits are documented on
QA-273. The audit will be kept in the equipment book and a copy will be given to
department management.
6.3.2 A CAR will be generated when:
6.3.2.1 Process or equipment deviations demonstrate a trend of unacceptable results
6.3.2.2 A customer complaint requires corrective action and documented follow-up
6.3.2.3 Defined corrective action is taken to ensure that the deviation does not recur and
whose effectiveness must be assessed after implementation
6.3.2.4 The deviation has an impact on previously completed processes or testing which
must be documented
6.4 Initiating a Corrective Action Report
6.4.1 The initiator of a CAR will complete form QA-072 and forward it to the Corrective Action
Coordinator.
6.4.1.1 Include specific contact names for additional information if applicable.
6.4.1.2 When describing the problem, or reason for the CAR, be as specific as possible
referencing pertinent procedures, regulations, customers, etc. Attach any additional
information that may be helpful.
6.4.2 Each COMPANY X facility has CAR mail boxes that can be used to forward to the CAR
Coordinator.
6.4.3 Form QA-208 must be completed and relayed to accounting when the following are confirmed
6.4.3.1 COMPANY X, customer or third party property damage
6.4.3.2 Interruption of COMPANY X business
6.4.3.3 Liability exposure due to BI sales, sterilization, testing or assembly/packaging
6.5 The Corrective Action Coordinator will proceed as follows upon receipt of the CAR:
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6.5.1 Review the CAR for completeness and sufficient information. The initiator may be contacted to
further clarify the request information.
6.5.2 Assign a CAR control number and enter such into the CAR Log (for tracking purposes).
6.5.3 Assign CAR Champion who will spearhead the investigation and follow through to completion.
6.5.4 Determine the QA Representative who has technical knowledge of the department or area
affected and will review the Action Plan.
6.5.5 Establish an Action Plan Due Date. This is the initial response to the CAR and will generally be
due in 10 working days.
6.5.6 Distribute the CAR to the initiator, QA Representative and the CAR Champion. When a CAR
has been initiated for a customer complaint, the Director of Quality will be copied.
6.6 The CAR Champion responsibilities include the following:
6.6.1 Respond to the CAR by the Action Plan Due Date stated on the CAR.
6.6.2 Determine and document short term or immediate actions needed to contain the problem, if
applicable. This may include purging stock, stopping all processing of orders, additional
inspection steps, etc. Immediate action shall identify any steps that were taken immediately
upon identifying the NC and provide information which doesn’t leave unanswered questions.
6.6.3 Assessing if the non-conforming conditions caused any impact of the testing/services.
6.6.4 Investigate the problem to determine Root Cause(s) and document the root cause on the CAR.
6.6.5 Document the Action Plan to prevent recurrence of the problem.
6.6.5.1 If more time is needed to investigate the problem, the CAR coordinator should be
contacted to negotiate a new due date. This should occur as soon as possible.
6.6.5.2 In cases of complex problems, only the initial steps to corrective action may be
known. Based on the results of those actions, more actions may be added at a later
date. This partial plan should be submitted by the action plan due date.
6.6.5.3 Document assigned responsibilities and target dates for each action of the plan and
final target completion date.
6.6.6 Upon completion of the Action Plan, sign and date the CAR and forward it to the QA
Representative for review.
6.6.7 Implementation of the plan may begin without further approvals or delay.
6.6.8 When the corrective action has been implemented, notify the CAR Coordinator.
6.7 The QA Representative will review the Action Plan, signify concurrence with the plan by signature/date
and forward the CAR to the CAR Coordinator.
6.8 The CAR Coordinator will review the CAR for completeness and confirm receipt by signature/date and
re-distribute to all original recipients.
6.8.1 The CAR’s are filed in the "Open CAR's" file. Note: The CAR’s may have repeated copies
issued. When filed by QA the filed original/copy must have original signatures.
6.8.2 Dates for follow-up and the items to be reviewed will be documented on the CAR.
6.9 Verifying Corrective Action Effectiveness, Final Inspection and Closure
6.9.1 When the corrective action has been implemented, the CAR Coordinator will enter the date into
the CAR log and will set a date to assess the effectiveness of the corrective action.
6.9.2 The CAR shall be closed if the Corrective Action Coordinator or designee and the CAR
Champion determine the corrective action is effective.
6.9.3 If the corrective action has not been implemented by the proposed date, the CAR Coordinator
will choose time(s) for additional follow up, based on the CAR Champion’s progress. If
progress has not been made after several follow-ups, the item will be included in a CAR status
report provided to the Leadership Team and department management, which is issued quarterly
or as otherwise requested.
6.10 CAR records will be maintained by Quality Assurance for two years.
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6.11 Any corrective action which involves required reporting to USDA will be handled according to REG-001.
6.12 Trend Analysis – Relevant information on identified quality problems as well as corrective actions will be
trended quarterly by the Corrective Action Coordinator and submitted to the Leadership Team, for
management review. Pie charts, bar graphs, pareto diagrams or other statistical methods will be used to
detect recurring quality problems.
6.13 Pro-Active Preventive Action is carried out in the following ways:
6.13.1 Opportunities for Improvement – All personnel may propose changes to the process in order to
increase process or cost efficiency or provide greater assurance that a process will be
conforming. Any opportunities for improvement can be submitted to department management
or Quality Assurance.
6.13.2 Opportunities for Improvement may also come from customers through the
Feedback/Complaint system – REG-014.2.
6.13.3 Subscription to services provided by Global Engineering Documents. This monthly service
makes us aware of revisions to the regulations, standards and guidelines upon which we base
our products and services.
6.13.4 Reading newsletters, trade journals or information from professional organizations. These are
forwarded by the reviewer to departments that may be affected.
6.13.5 Daily workday review of changes in the Federal Register/Code of Federal Regulations.
COMPANY X SOP REG-014 R- 12 Page 5 of 5

7 Revision History

The following are approved changes incorporated into revision numbers indicated below
Revision Description of Change
10 1. Reference REG 014.1 removed – obsoleted and incorporated into this SOP
2. Definitions: Facility addresses removed, complaint clarified, deviation added as
same meaning as nonconformance, N/C examples removed
3. References to ISC were changed to Leadership Team throughout
4. References to East Quality Manger were removed
5. New forms were added to Materials section
6. 6.2, 6.11, 6.12, 6.14, 6.17 were added or reworded to reflect 21 CFR 820.100.
7. 6.3 was added to introduce the use of deviation logs as an additional means for
tracking nonconformances
8. Examples were removed from sections 6.8, 6.9, 6.11, 6.12
9. Section 6.17 was reworded to add information from the Trend Analysis SOP,
REG-014.1
10. Approval header was changed to reflect new procedure
11. Administrative changes throughout
12. Codes were removed from 6.13.4 and 6.13.10
13. 6.14.4 was revised to indicate a CAR would be closed when the responsible
person and Corrective Action Coordinator agree on effectiveness of action
11 Removed all references to documenting complaints on the CAR form – Complaints
are handled per REG-014.2
Section 2 - Removed reference to Archive SOP
Section 3 - Definitions – Updated terminology to reflect new procedure and deleted
Leadership Team
Section 4 - Responsibilities - reworded entire section to define new responsibilities
Section 5 - Materials – omitted form QA-085
Section 6 - Procedure was rewritten to reflect changes to form QA-072 and to clarify
processing steps. Action plans are documented, QA rep for all CAR’s. Added
opportunities for improvement from customer feedback system
Administrative changes throughout

12 Added section 6.6.3 for assessing impact. The remainder of section 6.6.X will be
renumbered as a result of the addition.
Section 6.3.1 Was updated to add the 48-hour time period for logging deviations.