Quality…. Customer Satisfaction….

On-Time Delivery

Risk Management
Procedure
QA-072
 Risk Management Procedure

Document #: QA-072 Revision: B Date: 2/8/2022 Page 2 of 5

Contents
Policy Statement.........................................................................................................................................3
1. Definitions.......................................................................................................................................3
2. Personnel Responsibilities..............................................................................................................3
3. Methods..........................................................................................................................................4
4. Procedures......................................................................................................................................4
5. Revison History.........................................................................................................................5

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 Risk Management Procedure

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Policy Statement
XXX is committed to improving the quality management system, assembly, and testing services to
increase customer satisfaction.
Purpose: Scope: All XXX officers and staff members (full-
1. To establish a process and define the time, part-time and contract).
methods of identifying the risks and
opportunities associated with the key
processes of the QMS.
2. To provide guidance for completing risk
assessment and implementation of
preventative actions to mitigate risks.

MPS References: Associated Forms:

 QA-100 QMS Quality Manual  F-072 Process Matrix & Risk Worksheet
 QA-050 Corrective and Preventive Action  F-072.1 Risk Assessment Tool Guide
 QA-089 NPI Procedure  F-072.2 Risk Analysis Audit Checklist
 QA-011 Management Review Procedure  F-050.5 Preventive Action Request form

1. Definitions
1.1 Risk: A negative effect of uncertainty
1.2 Opportunity: A positive effect of uncertainty
1.3 Uncertainty: A deficiency of information related to understanding or knowledge of an event, its
consequence, or likelihood. (Not to be confused with measurement uncertainty.)
1.4 Risk Assessment: A systematic investigation and analysis of potential risks, combined with the
assignment of severities of probabilities and consequences. These are used to rate risks to
prioritize the mitigation of high risks.
1.5 FEMA (Failure Mode Effects Analysis): A specific risk treatment method which ranks risks by
probability and consequence.
1.6 Preventive Action: The effort to identify and reduce occurrences of risk.

2. Personnel Responsibilities
2.1. Top Management: Ensures that risk and opportunities are addressed at all levels of the
organization. Top Management also reviews activities undertaken to mitigate risk or capitalize
on opportunities as part of management review activities.
2.2. Human Resources: All employees shall receive orientation training covering Employee
Confidentiality and Conflict of Interest requirements.
2.3. Engineering: Assesses processes for risk and implement improvements to reduce their impact.
2.4. Quality Assurance: Monitors all processes of the QMS to determine whether risks,
opportunities, and preventive actions have been identified and actions are in place to minimize
the negative impact of occurrence.

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2.5. All Personnel: Consistently monitors all processes within the scope of the QMS and notify
Engineering and Management when risks are discovered, and preventive actions are identified.
3. Methods
2.1 XXX considers and manages risks, opportunities and preventive actions differently throughout
our processes.
2.2 Risks are managed with a focus on decreasing their likelihood, and minimizing their impact if
they should occur.
2.3 Opportunities are managed to increase their likelihood, and to maximize their benefits if they
should occur.
2.4 Preventive actions are managed to identify and address risks before they become
nonconformances.
2.5 Where risks, opportunities, and preventive actions overlap, the best appropriate method for
managing them shall be ascertained, given the situation at hand. Elements of such “blended”
uncertainties may require methods which both address the negative risk and positive
opportunity.

4. Procedures
4.1. Key processes of the QMS should identify the internal and external risks to our organization.
This is represented in the F-072 XXX Process Matrix & Risk Worksheet and includes the
following processes such as:
3.1.1 Contract Review
3.1.2 NPI Process
3.1.3 Corrective Action
3.1.4 Internal Audit
3.1.5 Change Management
3.1.6 Management Review
3.1.7 FMEA

3.2 Additional risks may be identified by any employee at any time and F-101.2 Risk Analysis Audit
Checklist can be used by any employee to investigate and identify any potential risk or
opportunities.

3.3 Risks identified should be addressed using the best appropriate methods based on the
situation at hand. These methods include but are not limited to:
3.3.1 PFEMA
3.3.2 Business Continuity Plan
3.3.3 Risk Assessment (F-072.1 Risk Assessment Tool Guide) reference
3.3.4 SWOT analysis (Strength, Weakness, Opportunity, Threat)
3.3.5 Final Inspection
3.3.6 Preventive Action requests

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3.4 The methods for addressing risks vary, but should always include a means of identifying the
consequence should they occur and an action to reduce the probability of occurrence.

5. Revision History

REV DATE INITIATOR DESCRIPTION OF CHANGE

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