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 ISO13485

2. Approval

(Version at end of page)

Signed V20  BN 05.06.2024   

3. Scope

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

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.

4. Responsibilities

 Approval: Author of the document, Henry Manyike

Changes: Author of the document, Bonang Ntuli

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 regards 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

ISO13485 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 System

1. IMPROVEMENT FORM  

2. IMPROVEMENT RESPONSE (INCIDENT)

3. CORRECTIVE ACTION FORM

4. CORRECTIVE ACTION RESPONSE

5. CORRECTIVE ACTION FOLLOW UP

6. CORRECTIVE ACTION FOLLOW UP REPORT (closure)

8.2 Improvement Form

An Incident, which may or may not follow corrective action, can be a FINDING 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  IMPROVEMENT 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

8.3 Process

1. The INCIDENT FORM  is completed - CLICK on IMPROVEMENT FORM

2. The nature of the incident above, e.g. customer complaint, audit finding, safety incident is recorded

3. The details OF THE COMPLAINT and / or INCIDENT are recorded, investigated and determined if corrective action is required 

4. The incident is registered in a IMPROVEMENT REGISTER (INCIDENT)  for Trend Analysis and Improvement 

5. CORRECTION, if required or applicable, is inserted or details added later into the register once completed

6. The CORRECTIVE ACTION FORM  can be generated by CLICK on CORRECTIVE ACTION by a responsible party or in the IMPROVEMENT REGISTER (INCIDENT) click on the FORM TAB and Send Form by email to the relevant party 

      I.E. (go to File>email collaborators (email go to > CORRECTIVE ACTION TAB and go to >form and >send form))

7. The CORRECTIVE ACTION RESPONSE  REGISTER is allocated a Closure date for the CORRECTIVE ACTION by the administrator

8. The CORRECTIVE ACTION is concluded and recorded  

9. CORRECTIVE ACTION is recorded by completion of the FORM and approved by the AUTHORISED REPRESENTATIVE

10. A CORRECTIVE ACTION FOLLOW UP  FORM is generated and performed by the Administrator

11. IMPROVEMENT REGISTER (INCIDENT) TAB ACTION follow up  report (Closure) and the  CORRECTIVE ACTION  is concluded

12 In the event that FURTHER corrective action and/or is required a new  IMPROVEMENT FORM  can be generated

8.4 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

8.5 Essential Requirements

8.5.1 - A.     Nonconformity review and disposition (8.1)

The management of the organization ensures the establishment of an effective and efficient process to provide for review and disposition of identified nonconformities.

Reviews of nonconformities are conducted by authorized 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 nonconformity and have the authority and resources to provide the disposition the nonconformity and to define appropriate corrective action.

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

8.5.2 - B.    Control of non-conforming product (8.3)

The organization 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 organization deals with nonconforming product by:

• 1. by taking action to eliminate the detected nonconformity; 

  2. by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; 

  3. 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.

8.5.3 - 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

8.5.4 - D.    Outcome of non-conforming product

The outcome is recorded on the IMPROVEMENT RESPONSE (INCIDENT) register and the Authorised Representative approves the outcome of the non-conforming product / material.

When nonconforming product is detected after delivery or use has started, the organization follows the process

8.5.5 - E.    Actions in response to non-conforming product detected before delivery (8.3.2). 

The organization 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) authorizing its use, release or acceptance under concession.

The organization 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 authorizing the concession is maintained (see 4.2.5)

8.5.6 - F.    Actions in response to nonconforming product detected after delivery (8.3.3)

When nonconforming product is detected after delivery or use has started,  the organization 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 organization, 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 organization that supplied it, or

— destruction of a medical device

8.5.7 - G.    Rework

The organization does not perform rework however if requested by the manufacturer, reworks will be in accordance with documented procedures following the IMPROVEMENT 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 the DRIVE. After the completion of rework, product is verified to ensure that it meets applicable acceptance criteria and regulatory requirements.

8.5.8 - 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.

8.6 Corrective Action (8.5.2)

The actions to eliminate the cause of nonconformities in order to prevent a recurrence are to be determined and corrective actions appropriate to the effects of the nonconformities applied.

The procedure provides for;

1. reviewing nonconformities (including customer complaints), 

2. determining the causes of nonconformities, 

3. evaluating the need for action to ensure that nonconformities do not recur, 

4. determining and implementing action needed, including, if appropriate, updating documentation 

5. recording of the results of any investigation and of action taken and 

6. reviewing the corrective action taken and its effectiveness. 

8.7 Preventive Action (8.5.3)

Product, Process & System Quality Risk assessments, and review thereof, determine action to eliminate the causes of potential nonconformities and prevent their occurrence refer SOP Preventative Action Risk Assessment

The Risk assessment provides for;

1. determining potential nonconformities and their causes, 

2. evaluating the need for action to prevent occurrence of nonconformities, 

3. determining and implementing action needed, 

4. recording of the results of any investigations and of action taken and 

5. reviewing preventive action taken and its effectiveness. 

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE 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 20, 05.06.2024 - BN - approved by HM

Revision 19, 26.07.2023 - NT changing point 8.2 wording from "incident form" to "Improvement form"

Revision 18, 18.05.2022 - NT - approved by HM

Revision 17, 17.11.2021 - NT - signed off from TNA
Revision 16, 27.08.2021 - TNA - updating responsibilities / addition of 4 new definitions

Revision 15, 07.01.2021 - TNA - New format with Responsibilities, Risk based approach and Records and revision history added and new google site format. Deletion of records location item/ addition of scope / numbering 

Revision 14,  Digitally signed on 21-10-2020 by NT

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

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

IMPROVEMENT RESPONSE (INCIDENT)           Google Site             indefinite                   n/a

Advisory Notice                                                 Google Drive             indefinite                   n/a

Additional information / records           Google Drive         indefinite                   n/a