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
(Version at end of page)
Signed V21 ML 29.10.2024
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.
Approval: Author of the document, Monica Lucas
Changes: Management Team
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.
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
ISO13485 Clause 8.1, 8.3, 8.5.2, 8.5.3
This procedure provides the process for managing Non-Conformances, Deviations, Concessions and Corrective Action and implementing effective corrective action.
CORRECTIVE ACTION FOLLOW UP REPORT (closure)
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
1.The IMPROVEMENT form is completed - CLICK on IMPROVEMENT FORM
2.The nature of the incident above, e.g. customer complaint, audit finding, is recorded
3. The details of the complaint are recorded
4. Incident is registered in a IMPROVEMENT RESPONSE (INCIDENT) register for Trend Analysis and Improvement
5. The CORRECTIVE ACTION can be generated by CLICK on CORRECTIVE ACTION by a responsible party or in the IMPROVEMENT RESPONSE register CLICK on the FORM TAB and send the FORM by email to the relevant party
6. I.E. (go to File>email collaborators (email go to > CORRECTIVE ACTION TAB and go to >form and >send form))
The CORRECTIVE ACTION RESPONSE register is allocated a closure date for the CORRECTIVE ACTION by the administrator
The Incident is investigated and recorded
CORRECTIVE ACTION is recorded by completion of the FORM and approved by the AUTHORISED REPRESENTATIVE
a CORRECTIVE ACTION FOLLOW UP form is generated and performed by the Administrator
CORRECTIVE ACTION FOLLOW UP REPORT (closure) and the CORRECTIVE ACTION is concluded
In the event that the corrective action and/or is required a new IMPROVEMENT FORM can be generated
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
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.
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:
by taking action to eliminate the detected nonconformity;
by authorizing 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.
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
The outcome is recorded on the IMPROVEMENT RESPONSE (INCIDENT) register and the Authorised Representative approves the outcome of the of the non-conforming product / material.
When nonconforming product is detected after delivery or use has started, the organization follows the process
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)
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
The organization does not perform rework however if requested by the manufacturer, reworks will be in accordance with documented procedures.
A REWORK FORM is completed
on Conclusion the CORRECTIVE ACTION FORM is completed
The FORMS take into account the potential adverse effect of the rework on the product.
The procedure therefore undergoes an approval process and is RECORDED on the DRIVE in the FORM sheet link.
After the completion of rework, product is verified to ensure that it meets applicable acceptance criteria and regulatory requirements as per QC verification details on the CORRECTIVE ACTION FORM and verified during Corrective Action.
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.
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;
reviewing nonconformities (including customer complaints),
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities 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.
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;
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
recording of the results of any investigations and of action taken and
reviewing preventive action taken and its effectiveness.
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
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.
Revision 21; 29.10.2024 - ML - Checked and Confirmed. Digitally signed by ML
Revision 20; 21.11.2023 - ML - Checked and Confirmed. Digitally signed by ML
Revision 19; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 18; 02.08.2021 - ML - POPI information added. Digitally signed by ML
Revision 17; 10.05.2021 - ML - Digitally signed by ML
Revision 16, 06.05.2021 New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new googlesite format. Amending links and Forms
Revision 15, Digitally signed on 15.01.2020 by ML
Revision 1-14, unknown due to googlesite change to new googlesite
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