NON CONFORMANCE CORRECTIVE ACTION

1. Purpose 

This document provides the process for the practices that must be followed for handling, reporting and recording Non-Conformance, Deviations, Concessions and Corrective Action and the effective Corrective Action.

This document covers the process for management of Non-conformance and Corrective Action in compliance of ISO 13485.

2. Approval

(Version at end of page)

Signed V26 MK 2024.02.20 - RB 20.02.2025

3. Scope

The process covers all documents and process and products as defined in the SOP.

4. Responsibilities

 Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Rachel Belcher

5. Definitions

Concession - A thing that is granted, especially in response to demands.

Correction - The action or process of correcting something.

Corrective Action – Action to prevent an recurrence. 

Preventive Action – Action to prevent an occurrence.

Non-Conformance - Failure to conform to accepted standards of behaviour. Synonyms: nonconformity Antonyms: abidance, compliance, conformation, conformity; acting according to certain accepted standards. Non-fulfillment of specified requirements.

Deviation- The action of departing from an established course or accepted standard. "deviation from a norm".

A Critical Deficiency - A deficiency which had produced, or led to a significant risk of producing, either a product which was harmful to the human patient or a product which could result in a harmful residue in a food producing animal. 

A Major Deficiency - A non-critical deficiency, which had produced or might produce a product which did not comply with its marketing authorisation. 

A Minor Deficiency - A deficiency where an observation made could improve the quality system and quality assurance approach of the manufacturer, but which did not have a major impact on the quality of the product. 

Rework - The action of redoing a production procedure for an item / batch in order to correct a defective/ faulty aspect/s (eg: packaging /  labelling / out of specification) mainly in regard to disposable products.

Repair - Is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again.

Maintenance - This is required for preserving the condition of an item (infrastructure, machinery, products).

Refurbishment - the process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors).

6. Abbreviations

PCA - Preventative and Corrective Action

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure 

PSO – Post Market Surveillance Officer 

MD – Managing Director 

PPE – Personal Protective Equipment 

7. References

ISO 13485 Clause 8.1, 8.3, 8.5.2, 8.5.3 

SOP Customer Complaints  

SOP Product Recall

SOP Post Market Surveillance

8. Procedure

This procedure provides the process for managing Non-Conformances, Deviations, Concessions and Corrective Action and implementing effective corrective action.

8.1.  Non-Conformance Form

A Non Conformance, which may or may not follow corrective action, can be a FINDING in any category from;

1.  an AUDIT (internal / external)

2. customer or client COMPLAINT

3. SAFETY incident

4. a SUPPLIER fault

5. A CUSTOMER return 

6. An adhoc FINDING with a procedure or process 

7. REWORK, where the procedure to do the rework together with a risk assessment

8. CHANGE CONTROL action, to cover the impact and consequential activities e.g. technical file review, notification of relevant regulators

9. A MANAGEMENT REVIEW action item

10. An improvement can be recorded and followed through the generation of an  NON CONFORMANCE form

Any of the above may involve NON-CONFORMING PRODUCT, that must be segregated, controlled and which may end as a REJECT for DISPOSAL or REWORK into a non-medical product or a compliant medical product for CONCESSIONAL release.

8.2. Process

1. The nonconformance form is completed only all except an action from management review that required corrective action - Non-Conformance From.

2. On submission the Incident is stored in a register for trend analysis and improvement.

3. The non-conformance is then evaluated by the Quality Department and an action item is added to the relevant Trello Board with a PURPLE label for product, a BLUE label for audit findings, a RED label for an adverse event and a GREEN label for others, unless the nonconformance is rejected.  

4. With a RED label (Adverse event) the Quality Assurance and Regulatory Affairs  Officer  and Authorised Representative should be informed immediately via email. 

5. Other colours are allocated in TRELLO for other actions relevant to other SOP.

6. The Incident is investigated by means of a root cause analysis, if this method of analysis is appropriate.  The template for performing a root cause analysis is included in the file section at the bottom of this page. The analysis template must be thoroughly completed and the output uploaded to the NC FORMS RECEIVED FOLDER. Information other than a root cause analysis can be attached to the TRELLO job card.  If no further action is required, the job card is completed and archived.

7. Corrective action can be taken if required and the output is attached to the original non-conformance, marked as complete and archived.

8. The register is then concluded with a link to TRELLO and conclusion date.

9. Timeline for NCCA Product:  30 working days excluding weekends. 

10. Timeline for NCCA Other:  90 Working days excluding weekends.

11. It is the QA and RA Officer's responsibility to ensure cards are processed.

12. Should timelines not be met a justification document needs to be submitted, the risk will be evaluated and will be approved or extended on a risk-based approach.

 8.3. Analysis

The Finding categories are graphically monitored as a PIE or COLUMN graph, by month, for input to Management Review and to monitor and measure the relevant Finding category, which is related to individual procedures e.g. supplier management, complaints handling, rework.

8.4. Essential Requirements

8.4.1. A. Non-Conformity Review and Disposition (8.1)

The management of the organisation ensures the establishment of an effective and efficient process to provide for review and disposition of identified non-conformities.

Reviews of non-conformities are conducted by authorised people to determine if any trends or patterns of occurrence require attention. Negative trends are considered for improvement and as input to management review where reduction goals and resource needs are considered.

Relevant management are assignment for carrying out the review to assure competence to evaluate the total effects of the non-conformity and have the authority and resources to provide the disposition the non-conformity and to define appropriate corrective action.

Acceptance of non-conformity disposition may require the contractual requirement of the customer, or a requirement of other interested parties.

8.4.2. B. Control of Non-Conforming Product (8.3)

The organisation ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery with controls detailed in "Identification and segregation of non-conforming product". The controls and related responsibilities and authorities for dealing with non-conforming product are defined in this procedure.

The organisation deals with non-conforming product by:

• By taking action to eliminate the detected non-conformity; 

• By authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; 

• By taking action to preclude its original intended use or application.

Records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, are listed under REPORT requirements.

When non-conforming product is corrected it is subject to re-verification/ retest to demonstrate conformity to the requirements through the follow up.

8.4.3. C. Identification and Segregation of Non-Conforming Product

Any non-conforming product is placed in an isolated area, separate room or separate location to ensure that the product is not dispatched to market – safety barrier tape may be used.

Product is identified with a QUARANTINE label as per Identification and Traceability SOP where one label is placed on all sides of a pallet or on the visible side of the box or the area is labelled.

8.4.4. D. Outcome of Non-Conforming Product

The outcome is recorded on the register and the Authorised Representative approves the outcome of the of the non-conforming product/ material.

When non-conforming product is detected after delivery or use has started, the organisation follows the process.

8.4.5. E. Actions in Response to Non-Conforming Product Detected Before Delivery (8.3.2). 

The organisation deals with nonconforming product by one or more of the following ways:

a) taking action to eliminate the detected non-conformity;

b) taking action to preclude its original intended use or application;

c) authorising its use, release or acceptance under concession.

The organisation ensures that non-conforming product is accepted by concession only if the justification is provided, approval is obtained, and applicable regulatory requirements are met. Records of the acceptance by concession and the identity of the person authorising the concession is maintained (see 4.2.5.).

8.4.6. F. Actions in Response to Non-Conforming Product Detected After Delivery (8.3.3)

When non-conforming product is detected after delivery or use has started, the organisation takes action appropriate to the effects, or potential effects, of the non-conformity.

• an advisory notice maybe required refer SOP Advisory Notice

• notice issued by the organisation, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:

— use of a medical device,

— modification of a medical device,

— return of the medical device to the organisation that supplied it, or

— destruction of a medical device

8.4.7. G. Rework

The organisation does not perform rework however if requested by the manufacturer, reworks will be in accordance with documented procedures following the Non-Conformance Form taking into account the potential adverse effect of the rework on the product. The procedure will undergo an approval process and be recorded and saved on SharePoint. After the completion of rework, product is verified to ensure that it meets applicable acceptance criteria and regulatory requirements.

8.4.8. H. Recall/ Withdrawal

In the event of the decision, after the investigation of a non-conformance, that a recall is required the system administrator will follow SOP Adverse Incidents Product Recall.

8.5. Corrective Action (8.5.2)

The actions to eliminate the cause of non-conformities in order to prevent a recurrence are to be determined and corrective actions appropriate to the effects of the non-conformities applied.  Corrective actions will be processed on Trello.

The procedure provides for:

• Reviewing non-conformities (including customer complaints), 

• Determining the causes of non-conformities, 

• Evaluating the need for action to ensure that non-conformities do not recur, 

• Determining and implementing action needed, including, if appropriate, updating documentation 

• Recording of the results of any investigation and of action taken and 

• Reviewing the corrective action taken and its effectiveness. 

Identifying corrective action:

• The person responsible will inform the CA (Corrective Action) team should a CA be identified when processing the NCCA data in the register.  

• The CA team will justify whether or not corrective action is required. Depending on the nature of the non-conformance, it is assigned to the appropriate department and resolved by the relevant team members.  

• The cross-functional team will conduct a root cause analysis to determine the cause of the non-conformance.  

• Rectify the issue with a corrective action plan and/ or preventative action plan.

• Review CA actions and approve.

• Timeline 90 working days excluding weekends. 

The effectiveness of the corrective action plan relies on the ability to determine the root cause of an issue.   

9. Risk Based Approach

In the event of non-compliance follow SOP Non-Conformance Corrective Action.

The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.

9.1. Trend Analysis and Continual Improvement

The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis to management review.

The Trend Analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. Revision History

Revision 27; 15.07.2024 - RB - Change over to SharePoint Site

Revision 26 20.02.2024 - MR - 20.02.2024 - RB - Relinked records in section 11, and updated the process 

Revision 25 19.05.2023-  CO-Change the title under 8.2.4  from customer service manager to QA/RA Officer

Revision 24; 15.08.2022 - MR - DK 15.08.2022 - Added corrective action process flow chart

Revision 23; 19.07.2022 - MR - DK 19.07.2022 - Moved Preventative action 8.6 to the Preventative action risk assessment section - remove duplicate posting 

Revision 22; 11.04.2022 - MR - 8.2 - Responsibility added  11 & 12

Revision 21; 22.02.2022 - MR - Add Corrective Action Timeline 

Revision 20; 15.02.2022 - MR - Update Corrective Action & Preventative Action

Revision 19; 14.02.2022 - MR - Google form & Register 2022 Linked

Revision 18;  14.10.2021 - MR - Updated Responsibilities, Records, CAPA

Revision 17, 30.08.2021 - TNA - addition of 4 new definitions

Revision 16, 05.08.2021 - MR - Reviewed

Revision 15, 24.06.2021 - TNA - New format with Approval, Scope, Responsibilities, Risk based approach and Records and revision history added and new google site format. Deletion of records location item/ addition of scope / numbering. amending links and forms

Revision 14,  Digitally signed on 20.07.2020 by WJW

Revision 1-13, unknown due to google site change to new google site

11. Records

Name Retained in Retention period Hard copies Destroyed by

Non-Conformance Form Microsoft Forms indefinite N/A

NCCA Register Current SharePoint indefinite N/A

NCCA Register Records SharePoint indefinite N/A

NC Forms Received SharePoint indefinite N/A

NC Templates SharePoint indefinite N/A

Non-Conformance Action Product Trello indefinite N/A

Non-Conformance Action Other Trello indefinite N/A

Advisory Notice Google Drive indefinite N/A

Additional Information / Records Google Drive indefinite N/A

Preventative actions Trello indefinite N/A

Corrective actions Trello indefinite N/A