PURPOSE

This procedure defines a method of managing risk through identification, assessment and mitigation using risk
management tools and techniques.
RISK IDENTIFICATION CRITERIA:
Risk identification associated with product delivery and quality shall include
- Facility/equipment availability and maintenance
- Supplier performance and Material availability/Supply
- Delivery of Non-Conforming Product
- Availability of Competent personnel
Risks and their impact may occur at any point during the Product Realization process or post-delivery.
Implementing corrective/preventive action and/or MOC may require Risk Assessment & Management.
RISK ASSESSMENT
Once a risk is identified, the designated person shall complete relevant sections of the Risk Assessment Form
(FM-XXX) while conducting a risk assessment
Probability of Risk is rated as defined in Table:
RISK EVALUATION
Based on assessment in Section 5.0 a Risk is evaluated as Low, Medium or High.
Choose a risk matrix, you can google
Using this evaluation Risk Level is then recorded on the Risk Assessment Form (FM-XXX).
For mitigation the scope required for each risk level is recommended below:

Risk Action scope

Level
Involvement of management
High
Immediate action required to reduce the risk
Specific monitoring and controls required
Medium
Risk should be reduced as far as reasonably possible
Low May require monitoring and controls
.
Relevant sections of Risk Assessment Form (FM-XXX) shall be filled out.

RISK MITIGATION

Risk mitigation involves lowering the risk level to an acceptable level determined during the risk evaluation
process.

The designated person shall coordinate with appropriate personnel to develop and implement a risk mitigation
plan.

Risk mitigation may involve a cyclical process of:

Implementing a risk mitigation plan

Assessing new level of risk
If new risk level is not tolerable, generate a new risk mitigation plan

Once a risk mitigation plan has been selected, the designated person may get it approved by the Management.

If the risk mitigation plan is not approved, a new plan shall be developed by the designated person.

The designated person shall implement the risk mitigation plan after being approved (if required).

MONITORING AND REVIEW

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Once a risk treatment has been implemented, the new risk level shall be determined and recorded on the Risk
Assessment Form (FM-XXX) by the designated person.

The designated person shall complete all remaining relevant sections of the Risk Assessment Form and forward it
to the QA

The QA shall complete the Risk Register and maintain relevant documents.

A significant risk may be included in Contingency Plan

RISK REGISTER NUMBERING SYSTEM

The risk identification number shall be taken from the next available number on the Risk Register

The format shall be as follow; choose your format.

RECORDS

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