RISK MANAGEMENT PLAN

L A B O R ATO RY A C T I V I T Y
NO.3
 HOW TO MAKE A RISK MANAGEMENT PLAN
1. Introduction
1.1 Purpose of the Risk Management Plan
2. Risk Management Procedure
2.1 Process
2.2 Risk identification
2.3 Risk Analysis
2.3.1 Qualitative Risk Analysis
2.3.2 Quantitative Risk Analysis
 HOW TO MAKE A RISK MANAGEMENT PLAN

2.4 Risk Response Planning

2.5 Risk Monitoring, Control and Reporting

3. Tools and Practices

THE SEVERITY OF RISK SHALL BE CATEGORIZED AS:
CATEGORY DESCRIPTION SCORE
CRITICAL Significant and highly catastrophic impact on product 1

HIGH Significant losses and respectively addressed 2

management intervention required

MODERATE Loss of operating capability, long term and problem 3

causes adverse effect
MINOR Impact on operation and efficiency , but limited effect 4

INSIGNIFICANT Very minor or no impact on operations and quality product 5

efficacy
 •Corrective Action: Elimination of the cause or causes of an
CAPA existing nonconformity or undesirable situation in order to
prevent recurrence.
(CORRECTIVE
ACTION AND •Preventive Action: Identification and elimination of the
PREVENTION cause(s) of potential nonconformities in order to prevent
ACTION) occurrence.

Activity No.4
CAPA
FRAMEWORK
 CAPA processes are used particularly in food
processing, medical device development and
manufacturing, and pharmaceuticals.

FDA 21 CFR 820 is the quality system

APPLICATION regulation that requires corrective and
preventive procedures to be documented in
OF CAPA medical device manufacturing facilities.
 Promptly identify and document the problem
Implement a correction or containment or temporary repair
Find the cause of the issue
STEPS
Determine IN the solution that will prevent a recurrence

SOLVING
Implement the corrective action and ensure that everything is documented.
Verify that the action continues to be effective and that the problem does not recur.
CAPA
Consequences of Noncompliance With Manufacturing SOPs

Lack of quality control - Manufacturing SOPs help produce high-

quality products consistently
Low productivity - Manufacturing SOPs are designed to improve
efficiency
Subjective performance evaluations - SOPs clearly define worker
tasks and responsibilities
Communication breakdown - SOPs communicate process updates
to workers
Increased risk of accidents - Safe work practices are often
integrated into manufacturing SOPs
 MODEL FORMAT FOR AN
EFFECTIVE SOP
Header – This should include the title, document number and version. The header should
clearly identify the activity in question and contain any relevant keywords.
1. Purpose–It needs to be detailed enough so end users can quickly recognize what the
document covers with no other detail included.
2. Scope - This defines to whom or what the particular set of procedures applies
 MODEL FORMAT FOR AN
EFFECTIVE SOP

3. References and Related Documents – Offer documents and references needed to

understand and effectively execute the procedures in addition to other SOPs, or government-
issued documents the SOP references.

4. Definitions - Clarify any terms that may not be familiar to end users and spell out
any acronyms or abbreviations that are used.
 MODEL FORMAT FOR AN
EFFECTIVE SOP
5.Roles and Responsibilities – Define the roles responsible for
executing activities within the procedure.

6. Procedure - The FDA wants to ensure that standards meet

compliance expectations without containing so much material that it
may actually create a compliance risk.
• Major steps: Your SOP should include only the steps necessary
for accomplishing the objective of the procedure.
• Individual action steps within each major step
• Notes: These should be provided separately and be given to
offer information for clarifying the process and/or responsibilities and
possible warnings.
 MODEL FORMAT FOR AN
EFFECTIVE SOP
7. Appendices – These typically work best as a flow chart to aid in
explaining the procedures during and audit or for those who learn
better visually

6. Revision History - Record the changes made to a procedure

and justification or the reason why the procedure was created.

Approval Signatures: This is usually found on the cover or the

back page. Some SOPs require various approval signatures. Key
roles in play include the Author, Reviewer, Management Approver,
and Quality Reviewer/Approver.