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QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
BUSINESS RISK AND OPPORTUNITY ASSESSMENT & PAGE 01 of 02
MANAGEMENT
Prepared By: Reviewed By: Approved By:
1. PURPOSE
a) Mechanism to identify and control risk and opportunity associated with product
quality and delivery.
b) Techniques and tools to be used for risk identification, assessment and mitigation
2. SCOPE:
2.2. Note: this procedure has adopted definitions for key terms developed specifically by UDL
Pharmaceuticals and determined appropriate for its use within the unique requirements of
its management system. It does not adopt current ISO definitions, which UDL
Pharmaceuticals has determined are not sufficient for its use.
2.3. Note: the QMS documentation occasionally uses the term “opportunity for improvement”
when discussing internal audit findings or management review actions; that term does not
have the same context as the term “opportunity” used herein.
3. DEFINITIONS:
3.4. 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 in order to prioritize the mitigation of high risks.
3.5. Risk Mitigation: a plan developed with the intent of addressing all known or possible risks
and preventing their occurrence.
3.6. FMEA (Failure Mode Effects Analysis): a specific risk treatment method which ranks
risks by probability and consequence.
4. RESPONSIBILITIES:
5. PROCEDURE:
5.1. GENERAL
5.1.1. UDL Pharma considers and manages risks and opportunities differently.
5.1.2. Risks are managed with a focus on decreasing their occurrence, minimizing their
severity and enhance the detection if they should occur.
5.1.3. Opportunities are managed to increase their likelihood, to maximize their benefits
and enhance the detection if they should occur.
5.2.1. A cross functional risk assessment team will perform process mapping starting
from supplier evaluation →purchasing →order receiving through to delivery of
product before processing risk assessment exercise
5.2.3. Risk assessment shall be performed on all steps coming in preview of following
parameters;
5.2.4. Each process is defined through separate detailed procedure and FMEA study will
be performed for teach process.
5.2.5. Risk Assessment Team will perform P-FMEA on “Process Failure Effect & Mode
Analysis” to identify potential risk (s).
5.2.6. The P-FMEA document includes the identification and mitigation plans for key risks
associated with the defined process. UDL Pharma management reviews these
risks and takes action to minimize them.
5.2.7. Risks identified as part of the P-FMEA exercise is logged within the “Process
Failure Effect & Mode Analysis” to identify potential risk (s). This indicates a rough
priority, as well as a selected risk treatment method.
5.2.8. Detailed methods may include P-FMEA (failure mode effects analysis), SWOT
(strength, weakness, opportunity and threat) or other tools. No single method is
used for all risk assessments; the tool selected should be the best tool applicable
to that particular risk analysis.
5.2.9. Risk register will be filled up to identify potential risks in each area, identify severity,
occurrence and detection ratings as per following table 1, 2 & 3 respectively.
5.2.10. Where P-FMEA style risk treatment is deemed optimal, an entry shall be made in
the P-FMEA Register. When using the P-FMEA Register, the following steps are to
be followed:
b) Identifying the process for which the risk most likely dominates.
5.2.11. Risk Priority Number (RPN) will be calculated as per following formula
5.2.12. For risks with a final Risk Factor rating equal to or greater than the 100 set in the
Risk Register, management will decide whether to reject the subject due to the risk,
or accept the risks after the development of a risk contingency plan. The
contingency plan must be documented, either in the Risk Register or in another
document which must be referenced on the form.
5.2.13. Risks with a factor less than the risk threshold may be accepted without a
mitigation plan, unless otherwise directed by management.
5.2.14. The final column allows for entry of an estimated risk factor after mitigation, which
is an estimate on what the risk should be reduced to if the risk treatment is
successful.
5.2.15. If a risk includes a potential positive aspect, management may elect to conduct an
opportunity pursuit assessment on the positive aspect, as defined below.
5.3.1. UDL Pharmaceuticals actively seeks out opportunities which could enhance its
financial viability and market position. For example:
development of new offerings that are within the scope of capabilities of UDL
Pharmaceuticals
5.3.2. A cross functional opportunity assessment team will perform process mapping
starting from supplier evaluation →purchasing →order receiving through to delivery
of product before processing risk assessment exercise
Document No. QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
BUSINESS RISK AND OPPORTUNITY ASSESSMENT & PAGE 01 of 02
MANAGEMENT
Prepared By: Reviewed By: Approved By:
5.3.4. Risk assessment shall be performed on all steps coming in preview of following
parameters;
5.3.5. Discussing and analyzing opportunities shall be done by top management. If made
part of the management review activities, these shall be recorded in the
management review records.
5.3.6. To help determine which opportunities should be pursued, the Opportunity Register
may be used to conduct an “opportunity pursuit assessment.” This register is
similar to the P-FMEA Register, but ranks potential positive opportunities by their
likelihood of success and potential benefit.
b) Identifying the process for which the opportunity most likely falls under.
5.3.8. Opportunity Priority Number (OPN) will be calculated as per following formula
5.3.9. For opportunities with a final Opportunity Factor rating equal to or greater than the
100, management will decide whether to pursue the opportunity through an
“opportunity pursuit plan” or to abandon the opportunity altogether. The opportunity
pursuit plan must be documented, either in the Opportunity Register or in another
document which must be referenced on the form.
5.3.10. Opportunities with a factor less than the opportunity target rating may be
abandoned outright, unless otherwise directed by management.
5.3.11. Analysis of any opportunity will generally result in one of the following possible
determinations:
Occurrence
Severity
Ranking Severity Description
Catastrophe, without
10
warning Predicted to cause severe impact to quality and business
Catastrophe, with (Product out of specifications, Customer Sue , Legal Action)
9
warning
8 Very High Predicted to cause significant impact on quality and delivery
(Failure to meet specifications, Late delivery, Customer
7 High Complaint)
6 Moderate Predicted to cause Moderate impact on quality and delivery
5 Low (Quality within specifications and Target Dates Meet)
Detection