Corrective Action Process
Version: 2.3
Last Updated: 01/19/2021
DCN: VMD-CAR-001
Confidential and Proprietary – All Rights Reserved
Approval Date: 01/19/2021
Approved By: QUAL
DCN: VMD-CAR-001
Version: 2.3
Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Table of Contents
1 Scope and Purpose.............................................................................................................................1
2 Roles and Responsibilities.................................................................................................................1
3 Inputs.................................................................................................................................................1
4 Outputs..............................................................................................................................................1
5 Entrance Criteria................................................................................................................................1
6 Exit Criteria.......................................................................................................................................1
7 Process Flow......................................................................................................................................2
8 Procedure...........................................................................................................................................2
8.1 Initiating a Request for Corrective Action........................................................................................................2
8.2 Investigating a Request for Corrective Action..................................................................................................2
8.3 Implementing Corrective Action......................................................................................................................2
8.4 Verifying Corrective Action.............................................................................................................................3
8.5 Closing Corrective Action Requests.................................................................................................................3
8.6 Periodic Review of Data...................................................................................................................................3
9 Risk Considerations...........................................................................................................................3
10 Reference Documents........................................................................................................................3
Appendices..................................................................................................................................................4
Appendix A: Acronyms and Key Terms..........................................................................................................................4
Appendix B: Documents and Records..............................................................................................................................5
Appendix C: Reporting Thresholds..................................................................................................................................6
List of Tables
Table 1: Roles and Responsibilities..................................................................................................................................1
Table 2: Acronyms........................................................................................................................................................... 4
Table 3: Key Terms.......................................................................................................................................................... 4
Table 4: Documents and Records.....................................................................................................................................5
Table 5: Reporting Thresholds.........................................................................................................................................6
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
List of Figures
No table of figures entries found.
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Revision History
Rev. # Release Date Author Reviewer(s) Approver Description of Change
1.0 03/10/17 CRB Baseline version of document
1.1 04/18/17 S. Becker M. Couto CRB Baseline version of document. Updated to new
template; added Inputs/Outputs, Entry/Exit
Criteria, Roles and Responsibilities
2.0 06/17/19 M. Couto M. Couto M. Couto Updated to reflect new brand and replace CRB
references to QUAL or MRB as needed
2.1 11./19/19 M. Couto M. Couto Updated to include directions to create CAR
form and upload to new CAR log SharePoint list
2.2 11/20/2020 J. Kim Updated to include IMS, additional inputs and
entrance criteria, and tools for analysis
2.3 01/19/2021 J. Kim M. Couto M. Couto Updated links within document
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
1 Scope and Purpose
The purpose of this document is to define the process for determining and implementing effective corrective actions
for the Integrated Management System (IMS) which includes the Quality Management System (QMS), Service
Management System (SMS), and Information Security Management System (ISMS).
2 Roles and Responsibilities
The table below presents the roles and responsibilities required for the successful implementation of this process.
Table 1: Roles and Responsibilities
Role Responsibility
Implements and maintains the corrective action process.
Quality Program (QUAL)
Provides support, including resources, to effectively address issues that are
Management Review Board (MRB)
generated because of the corrective action system.
Identifies nonconformances and suggesting improvement opportunities when
All VMD employees
they identify a potential nonconformance.
3 Inputs
Inputs are the policies, processes, documents, records, environmental or organizational factors, or any other factor
that exist prior to the process being initiated and influence process performance. The process relies on the following
inputs:
Nonconformance that has been communicated by a customer, an internal or external audit, or from a direct
observation by an employee.
Outcomes that are either positive or negative. Significant differences from what was expected indicate
where the project can improve its performance by:
o Determining why it went well and how to change to incorporate the experience into the normal
behavior
o Determining why expectations were not met and the changes needed to meet them
4 Outputs
Outputs are the processes, documents, records, or other factor that is produced or changed by the process. The
process generates the following outputs:
Corrective Action Form
5 Entrance Criteria
Entrance criteria describe the conditions that should exist prior to a process being initiated. The entrance criteria for
the process include:
Nonconformance that has been communicated by a customer, an internal or external audit, or from a direct
observation by an employee.
A positive or negative outcome that is the result of a significant difference from what was expected.
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
o When picking outcomes to analyze, consider:
Source
Impact
Frequency of occurrence
Similarity
Cost of analysis
Time and resources needed
Safety considerations
Security considerations
Performance
6 Exit Criteria
Exit criteria describe the conditions that should exist prior to concluding the process. The exit criteria for the process
include:
Verification that action was taken to mitigate the nonconformance.
Review of closed corrective action during Quality review and/or MRB.
7 Process Flow
There is currently no process diagram.
8 Procedure
8.1 Initiating a Request for Corrective Action
QUAL determines criteria for how non-conformances are reviewed and communicated and when corrective action is
required. They will also determine timeframe requirements associated with the steps of the process. These time
requirements will be relative to the severity of the nonconformance encountered.
Any employee can initiate a request for corrective action. This request can stem from a nonconformance that has
been communicated by a customer, or from direct observation by the employee. This includes supplier corrective
actions.
Corrective actions may be generated from the Internal Audit process. Corrective actions may also be generated from
the Management Review process. Details about issues are recorded on the Corrective Action Request (CAR) Form
and added to the Corrective Action Log.
QUAL staff assign an investigator and schedule based on the degree of nonconformance or potential
nonconformance.
To create a new Corrective Action Record:
Download the Corrective Action Record Template.
Enter required information.
Navigate to the Corrective Action Log.
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Create a new record, complete the information in the Corrective Action Record (CAR) Log and attach the
corrective action record you created.
8.2 Investigating a Request for Corrective Action
The investigator determines the cause of the nonconformance or potential nonconformance and designs the
implementation plan to address.
The investigator is responsible for finding root cause and determining both short-term containment and permanent
corrective actions, as required.
8.3 Implementing Corrective Action
Upon investigation, the QUAL staff assigns a responsible individual to ensure implementation actions are performed
as required.
This person is responsible for implementing or overseeing the implementation of actions to be taken. A summary of
actions taken is recorded on the CAR Form.
8.4 Verifying Corrective Action
The responsible person records the results of the action taken and review with QUAL staff to determine whether the
action was effective.
If the action was determined to not be effective a new corrective action may be issued.
If the action was determined to be effective the request will forward to QUAL for closure.
8.5 Closing Corrective Action Requests
Upon final review, the Director of Quality closes the corrective action(s).
8.6 Periodic Review of Data
Corrective Action owner should review and update the status of active corrective action(s) at least monthly.
The status of active corrective action(s) is reviewed at Internal Reviews and periodically by the MRB.
Periodically, the Director of Quality reviews records of previously issued corrective action(s) to summarize any
trends and to initiate further action as needed.
The effectiveness of the corrective action system is reviewed as an agenda item during Management Reviews.
9 Tools for Analysis
Pareto Chart/Diagram – analyzes defects/problems for root causes and arranges results from most to least
frequent
Histogram – summarizes data and shows frequency distribution
Five (5) Whys – helps to identify root cause of problem and exposes weaknesses in the systems or
processes
o May not be suitable to tackle complex or critical problems
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Control Chart – Determines the stability of a process (measurements over time) against predetermined
limits
o Rule of Seven – 7 or more consecutive points (above/below mean, trending) may indicate the
process may be out-of-control.
Scatter diagram – identifies possible relationships between two variables
10 Risk Considerations
Consider the following risk areas that may impact the performance of this process:
If corrective actions are not issued and formally documented, then problems may go unnoticed and
unresolved.
If a root cause analysis is not conducted on problems, then actions taken to resolve the problem may not be
effective as they do not address the real source of the problem.
If CAR Forms are not documented, then VMD Leadership may not have visibility into key problems and
may not be able to provide support.
11 Reference Documents
The following documents relate to this process:
Integrated Management System (IMS) Manual
Control of Documented Information Process
Internal Audit Process
Risk Management Process
Operations Process
Human Capital (HC) / Talent Acquisition (TA) Process
Business Development / Proposal Management Process
Subcontracting Process
Supplier Evaluation Process
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Printed copy valid for 24 hours from time of printing unless otherwise indicated “CONTROLLED COPY”.
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Appendices
Appendix A: Acronyms and Key Terms
The following tables present the definitions for acronyms and key terms used in this document.
Table 2: Acronyms
Acronym Definition
CA Corrective Action
CAR Corrective Action Request (form)
MRB Management Review Board
QUAL Quality Program (led by the Director of Quality)
Table 3: Key Terms
Key Terms Definition
Nonconformance A deviation from an expected result or standard.
Observed practice or product does not equal documentation.
Verbal description does not equal documentation.
Documentation or practice does not meet the requirements of the ISO 9001, 20000, or
27000 standards.
Corrective Action Action taken to eliminate underlying causes to nonconformances to prevent them from
recurring.
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Appendix B: Documents and Records
The following table presents the documents and records generated from the process, including the file format and
location of the record(s).
Table 4: Documents and Records
Document / Controlled? If Controlled, Frequency
Record Name Location
Record Type (Yes / No) of Review
Document IMS Manual IMS Process Library Yes Annually
Document Corrective Action Process IMS Process Library Yes Annually
Document Corrective Action Request IMS Process Library Yes Annually
Form Template
Record Corrective Action Log HQ Trackers Yes Monthly
Record Closed Corrective Action HQ Trackers No
Request Records
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Corrective Action (CAR) Process
Version: 2.3
Approved By: QUAL, 01/19/2021
Appendix C: Reporting Thresholds
The following table presents the compliance thresholds for the measures, if any, that are tracked for this process.
The corrective action process must be followed for all Items that do not meet the threshold.
Table 5: Reporting Thresholds
Item Threshold Notes
Number of Overdue Less than five (5) Corrective Action Requests where today's
Corrective Action Requests date is 90 days greater than expected implementation date
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