PREVENTIVE ACTION RISK ASSESSMENT
1. Purpose
This document provides the process for Quality Risk Assessment in compliance with ISO13485 for processes, products, events such as non conformance, as applicable and required by regulations
2. Approval
(Version at end of page)
Signed V15 HJM 4.11.2022
3. Scope
The process covers all documents and process and products as defined in the SOP
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis
Changes: Author of the document, Alexi Arhondonis
5. Definitions
Preventive Action - to prevent a hazard and/or risk from occurrence using a risk based approach and/or a risk assessment
Risk - combination of the probability of occurrence of harm and the severity of that harm
Hazard: Something with the potential to cause harm
Hazardous Outcome: A description of how someone could be hurt or damage could occur as a result of interacting with the hazard
Risk Rating: The overall judgement of the level of risk which may arise from the hazard, based upon the likelihood of the event occurring and the potential severity of the consequence
Mitigation / Control Measures: Method used to reduce or control risks arising from identified hazards; in consideration of mitigating (justifying / qualifying) circumstances, which are provided by the level of risk from the risk evaluation, the Control and Risk Management Decision
Residual Risk: The level of risk remaining once control measures have been applied to reduce
Probability - the extent to which an event is likely to occur, measured by the ratio of the favorable cases to the whole number of cases possible
Severity - measure of the possible consequences of a hazard; the fact or condition (of something bad or undesirable) happening / occurring, very great; intense
CCP - Critical Control Point is the point where the failure of a process, procedure, activity that could cause harm to customers and to the business, or even loss of the business itself.
6. Abbreviations
SOP- Standard Operating Procedure
QMS - Quality Management System
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action
PARA - Preventative Action Risk Assessment
CCP - Critical Control Point
7. References
ISO13485 clauses 8.2.4 & 5.6
ISO14971:2012
PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT
8. Procedure
8.1 ISO13485 RISK REQUIREMENTS
Risk Management is covered in Design & Development (7.3) for manufactured products by the manufacturer
The standard mentions Risk (not limited to);
8.2 PROCESS RISK BASED APPROACH
The Risks identified for Processes e at the start of generating a new procedure and after a trigger for the review if the risk is identified as an outcome of management review, internal audits and any other identified improvement opportunity.
The risk is evaluated using the following table where the justification for determining a Risk Aspect as Low, Medium or High, for the Probability and Severity, is includes in the table
Overall Risk is
High:High = High, Med:High = High
High: Med = Med, Med: Med = Med, Low:High = Med, Low: Med = Med
High:Low = Low, Low: Low = Low
refer Document
8.3 PRODUCT RISK ASSESSMENT
Not applicable as this is not a manufacturing site
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 through Data Analysis to management and as part of the input 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 15, 4.11.2022 - HJM - 8.2 PROCESS RISK BASED APPROACH redefined for establishing High, Medium and Low overall risk
Revision 14, 19.08.2021 - AA - updating Information
Revision 13, 01.07.2021 - TNA - updating responsibilities
Revision 12, 03.05.2021 - AA Approved
Revision 11, 29.04.2021 - TNA - New format with Approval, Scope, Responsibilities, Risk based approach and Records added and new googlesite format. Amending links.
Revision 10, Digitally signed on 22.06.2020 by AA
Revision 1-9, unknown due to google site change to new google site
11. RECORDS
Name Retained by/ in Retention period Hard copies Destroyed by
Product Risk Assessment Not applicable
Risk Based Approach for Quality Risk assessment each SOP Indefinite by Google Site n/a