QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

1 Purpose ......................................................................................................................................................................... 2
2 Scopes .......................................................................................................................................................................... 2
3 Responsibilities and Authority ....................................................................................................................................... 2
3.1 Key........................................................................................................................................................ 2
4 Revision Histories.......................................................................................................................................................... 2
5 Procedures .................................................................................................................................................................... 3
5.1 Generalities ................................................................................................................................................. 3
5.2 Raised situations ......................................................................................................................................... 4
5.2.1 Non Conformance Reporting .............................................................................................................................. 4
5.2.2 Safety incidents ................................................................................................................................................... 4
5.2.3 Audit CAPA ......................................................................................................................................................... 4
5.3 Detecting and analyzing causes .................................................................................................................. 4
5.4 Initiating CAPA .......................................................................................................................................... 4
5.4.1 Correction............................................................................................................................................................ 5
5.4.2 Corrective action ................................................................................................................................................. 5
5.4.3 Preventive action................................................................................................................................................. 5
5.5 Implementation, follow-up and improvement ............................................................................................ 5
6 Related documents ....................................................................................................................................................... 5
7 Terms and definitions .................................................................................................................................................... 5

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 QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

1 Purpose
This SOP defines the method for describing the process required to initiate CAPA following a non-compliance and
monitor their implementation.

2 Scopes
This procedure applies to all documentation for internal organization in Quality System Management of Power Container
Corporation (PCC).

Corrective action and preventive action are improvements to our processes taken to eliminate causes of non-
conformities or other undesirable situations. It focuses on the systematic investigation of the root causes of non-
conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive
action)

3 Responsibilities and Authority

Task Responsible Accountable Consult Inform

Initiating NCF Anyone DO QM

Detecting the cause QA Engineer DO Engineering QM

QC
Evaluating CAPA QA Engineer QM
Supervisor

Implementing CAPA DO QA Engineer QM

Evaluate CAPA
QA Engineer QM DO
Close out

3.1 Key
• Responsible : Doing The Task
• Accountable : Owning The Task
• Consulted : Assisting
• Informed : Keeping Aware

4 Revision Histories

Date: Revision: Description of Revision:

Apr. 7, 20 A Initial release

Nov. 10, 20 B Update Reporting through MS Forms

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 QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

5 Procedures
5.1 Generalities
When a non-conformity, or when anything is not in line with the process activities expectations, are detected, an
electronic NCF in Case of internal or safety issue or use in case of Customer Complaint us the electronic CC Form that
will Automatically Create a CAPA on MS Planner in order to eliminate the cause of the non-conformity or deviation.

The Quality Engineers in coordinate with Director of Operations will designate a Person Responsible for Implementation
(PRI) in order to identify the root cause. The PRI shall have the necessary competence, availability, and legitimacy to
implement the corrective action. He shall:
• Use MS Planner Card to record actions and causes and communications
• Use Form QR 0302 for CAPA for externally communicated matters
• If applicable Use Form QR 0303 for RCA as a guide to find the root cause
• Implement and follow up implementation in respect of deadline in CAPA

A non-conformity, or deviation may have various causes, and it may be necessary to combine various corrective actions.
Non-conformities and deviations may result from:
• Internal audits;
• External audits namely Clients, Certifications Bodies;
• Any suggestions, complaints or remarks.

Non-conformities are graded by the Auditor and confirmed by the Quality department in non-audit situations as:
1. Major: a systematic non-fulfillment of a critical requirement that jeopardizes a process of the management
system, posing a serious threat to safety, security, or quality;
2. Minor: an isolated non-fulfillment of a requirement, which does not jeopardize a process of the management
system.
3. Observation: a deviation that may cause nonconformance if not corrected.

Deviations described in the Corrective Action Request shall be managed by the Document Owner.

Timeline for closing of major non-conformity: Mandatory 1 week

Timeline for closing of minor non-conformity: Mandatory less than six months
Timeline for closing of observation: not mandatory Recommended, less than six months

When the non-conformity is issued after an external audit, the timescale presented shall be respected. Delays for closing
non-conformities issued after an internal audit shall be respected.
All non-conformities shall be described, analyzed, and assessed with the objective to avoid reoccurrences and to
improve the effectiveness of PCC Management System.
Source examples are (but not limited to):
1. Audit recordables.
2. Safety incidents.
3. Client Action Plans.
4. Documentation Reviews.
5. Improvement Action Plans.
6. Inspections Results.
7. Management Reviews.
8. Risk Assessment actions.
9. Action Plans.
10. Supplier Evaluations.

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 QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

5.2 Raised situations

5.2.1 Non Conformance Reporting

Potential non-conformities, suggestions, remarks or complaints shall be filled in the NCF by all Employees That will be
added to the system Automatically.
If the NCF is not relevant QE will add his/her Note on the card and close it (complete), If the situation reported is
relevant, Quality Engineer will:
1. Assign PRI(s) to the Planner Card
The Non-conformance related to Shipping / Receiving, Incoming Control, In-process Control, safety issues and
problems associated with machines should be notified via creating NCF (Non-conformance Form).

Steps to create NCF:

1. Scan the QR code and NCF form will appear or use the Link.
2. Fill in the details related to Non-conformance (Product, Process, Material)
3. Submit the form and Internal Complaint will be created in CAPA planner.

2. Observation if the non-conformity/situation has not occurred but may occur.

5.2.2 Safety incidents

All hazard and unsafe behaviors in PCC shall be reported using the NCF. When hazard or unsafe behaviors cannot be
adequately addressed or corrected on personnel level, it shall be submitted to the Director of operations.

A NCF shall be submitted by Operators, Line leads.

5.2.3 Audit CAPA

A non-conformity or observation detected during an Audit shall be reported in the Non-Conformities report form / CAPA.
The Audit Team is responsible for describing the situation. Evidences shall be kept and registered.
Once the non-conformity or observation is described, the Audit Team Leader shall grade in the Audit Summary as Major,
Minor or Observation.
These conclusions and their supporting audit evidences shall be recorded.

Once graded, conclusions shall be reviewed with the Auditee to obtain acknowledgement that the audit evidence is
accurate, and that the non-conformities and observations are understood. Every attempt shall be made to resolve any
diverging opinions concerning the audit evidence and/or findings, and unresolved points shall be recorded.

The Audit Summary is the record evidence of the conducted audit against the Auditee’s implementation of the
Management system.
The Audit Team shall present the Audit Summary at the end of the closing meeting in order that the Auditee shall keep
the necessary information which shall allow to immediately identify which corrective actions shall be taken to improve
its Management System.
5.3 Detecting and analyzing causes
A root cause is a source of a deviation or non-conformity, which if removed or mitigated, it will respectively disappear or
decrease to acceptable levels.
Each non-conformity shall originate a root cause analysis to establish a corrective action.

For assessing and analyzing causes, “QR-0303-RCA” may be used.

5.4 Initiating CAPA

When identifying a CAPA, consideration shall be given to:
• Customer Focus.
• Leadership.

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 QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

• Involvement of people.
• System approach to management.
• Continual improvement.
• Factual approach to decision making.
• Mutually beneficial supplier relationships.

If a non-conformity or observation has various causes, it can be necessary to combine CAPAs.

All audit CAPAs and CAPA Requests shall be filled in a Findings Action Record, by the Quality Department.

Once completed, the CAPA shall be approved by the Document Owner before closure. If the CAPA is not approved,
another CAPA shall be proposed until approval.

5.4.1 Correction
correction is just an action to eliminate a detected non-conformity. It is recommended but not mandatory to involve
experts during this phase.

5.4.2 Corrective action

A corrective action is an action to eliminate the Contributing Cause of a detected non-conformity or other undesirable
situation.

5.4.3 Preventive action

corrective action is an action to eliminate the root cause of a detected non-conformity or other undesirable
situation.

5.5 Implementation, follow-up and improvement

Once approved, the CAPA shall be sent to the Person Responsible for Implementation. The implementation phase shall
be monitored, and evidences shall be recorded.

The completed NCR / CAPA Request shall be forwarded to all parties involved in the process.

Effectiveness of any corrective/Preventive action taken shall be assessed. When evidences of completion and
effectiveness of action has been verified, the corrective action shall be closed.

Audit CAPAs shall be consolidated by the Quality department in the Findings Action.

6 Related documents
QR-0301 - CAPA Plan (only for older CAPAs)
QR-0302 - CAPA record
QR-03-03 - RCA
MS Form – Customer Complaint Recording
MS Form – Non Conformance Form

7 Terms and definitions

Audit
Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to
determine the extent to which the audit criteria are fulfilled.

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 QMS SOP 03

Corrective action / Preventive Action

CA / PA Revision B

Process Owner QM Date Nov. 10, 20

Correction
Action to eliminate a detected non-conformity.

Corrective action
Action to eliminate the cause of a detected non-conformity.

Person Responsible for Implementation (PRI)

Person designated by a Process Owner in order to identify adequate improvement actions. The Implementation
Responsible shall have the necessary competence, availability, and legitimacy to define and implement the improvement
action.

Inspection
Conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging.

Non-conformity
Non-fulfillment of a requirement.

Major non-conformity: shall be understood as a systematic non-fulfillment of a critical requirement that jeopardizes a
process of the management system, posing a serious threat to safety, environment, security, or quality.

Minor non-conformity: shall be understood as an isolated non-fulfillment of a requirement, which does not jeopardize a
process of the management system.

Objective evidence
Data supporting the existence or verity of something.

Preventive action
Action to eliminate the cause of a potential non-conformity.

Record
Document stating results achieved or providing evidence of activities performed.

Requirement
Need or expectation that is stated, generally implied or obligatory.

5 Why’s
The 5 Why’s is used to identify the root causes of a problem to avoid analyzing superficial causes.

NCF
Non-Conformance Form.

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