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 V17 HJM 8.05.2023
Approved 25.05.2022 SCR (RP)
3. Scope
The process covers all documents , process and products as defined in the SOP
4. Responsibilities
Approval & Changes: Author of the document, Alexis Arhondonis, medicines; RP SC Rudolph-Shortt
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 a recurrence
Preventive Action – action to prevent an occurrence
QUARANTINE/ D - is to contain the contamination such that others are not put at risk or Products or items in the quarantine are taken out of availability; these could be uncertain / not yet verified non conforming / compliant products from receipt goods, returns, rejects, complaints, expired stock
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" or the failure to fulfil a specified requirement in terms of processes, standards and regulations as prescribed by the Pharmacy Act and the Medicines Act
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
8. Procedure
This procedure provides the process for managing Non-Conformances, Deviations, Concessions and Corrective Action and implementing effective corrective action.
8.1 System
8.2 Incident Form
An Incident, which may or may not follow corrective action, can be a FINDING category from;
1. an AUDIT (internal / external/ medicines SELF INSPECTION)
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 INCIDENT 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
1The NON-CONFORMANCE FORM is completed - CLICK on INCIDENT FORM
The nature of the incident above, e.g. customer complaint, audit finding, is recorded
The details OF THE COMPLAINT are recorded
The incident is registered in a INCIDENT RESPONSE REGISTER for Trend Analysis and Improvement
The CORRECTIVE ACTION FORM can be generated by CLICK on CORRECTIVE ACTION by a responsible party or in the RESPONSE REGISTER 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))
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 AUTHORIZED REPRESENTATIVE
A CORRECTIVE ACTION follow up FORM is generated and performed by the Administrator
NON CONFORMANCE 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 NON-CONFORMANCE INCIDENT 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 given an 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 for 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:
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.
8.5.3 - C. Identification and segregation of non-conforming product
Any non-conforming product is QUARANTINED 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 NON CONFORMANCE 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 and an advisory notice maybe required refer SOP Advisory Notice.
If notice is 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 NON-CONFORMANCE INCIDENT 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;
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.
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;
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.
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[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 17, 8.05.2023 - HJM - Corrected hyperlinks for the 2023 forms and 2023 tabs from the DRIVE
Revision 16, 19.08.2021 - AA - 25.05.2022 SCR (RP) inclusion of medicines SELF Inspection incidents
Revision 15, 19.08.2021 - AA - Updating Information / addition of 4 new definitions
Revision 14, 01.07.2021 - TNA - updating responsibilities
Revision 13, 03.05.2021 - AA Approved
Revision 12, 29.04.2021 - TNA - New format with Approval / Scope/ Responsibilities, Risk based approach and Records and revision history added and new google site format. Amending links and forms updating numbering
Revision 11, Digitally signed on 07.12.2020 by SCR
Revision 1-10, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
NON CONFORMANCE RESPONSE REGISTER Google Site indefinite n/a
Advisory Notice Google Drive indefinite n/a
Additional information / records Google Drive indefinite n/a