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Sample Risk-Opportunity Assessment Report

This 3-page risk/opportunity assessment report analyzes the quality management system (QMS) processes and interested parties at a company to identify risks, opportunities, and compliance obligations. It lists several QMS processes/interested parties in the first column, with their corresponding requirements/needs/expectations and identified issues in the second column. The third and fourth columns describe the current risks or opportunities, along with their probability and impact exposure levels. The fifth column outlines current control methods like standard operating procedures. The last few columns indicate if further action is needed to address issues, recommended actions, responsible individuals, and status updates. The overall document performs a risk/opportunity analysis of the QMS to help the company meet

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Catherine Ferreol
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579 views3 pages

Sample Risk-Opportunity Assessment Report

This 3-page risk/opportunity assessment report analyzes the quality management system (QMS) processes and interested parties at a company to identify risks, opportunities, and compliance obligations. It lists several QMS processes/interested parties in the first column, with their corresponding requirements/needs/expectations and identified issues in the second column. The third and fourth columns describe the current risks or opportunities, along with their probability and impact exposure levels. The fifth column outlines current control methods like standard operating procedures. The last few columns indicate if further action is needed to address issues, recommended actions, responsible individuals, and status updates. The overall document performs a risk/opportunity analysis of the QMS to help the company meet

Uploaded by

Catherine Ferreol
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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Doc.

#:
RISKS/OPPORTUNITY ASSESSMENT REPORT Revision
(977444-P)
Rev Date:
Department: Assessment Date: Standard: ISO 9001:2015 QMS Updated
Requirements/ Needs/
QMS Processess / Interested Parties Risk / Opportunity Analysis Primary Action Residual Action
Expectation / Issue Identification

NewRating
Current Rating after
Risks improvement
Quality Management Process

(Negative) / Need
Opportunity Description of further Recommended Action Status
Interested Parties

QMS Process / Interested Requirements / Needs / Expectations / (Positive) Current Control / Methods (SOP, WI, PFM Action (tick)
No Risks (Negative) /

Exposure (L / M / H)

Exposure (L / M / H)
Parties / Compliance Obligation Issues (tick) Ref)
Opportunity (Positive)

Probability (O)

Probability (O)
Impact (S)

Impact (S)
Risk
QMS IP Opp. Yes No Recommendation PIC (Name) Effective Date Closed Open
s

page 1 of 3 NEI-F-100-ROAR/Rev.00
Doc. #:
RISKS/OPPORTUNITY ASSESSMENT REPORT Revision
(977444-P)
Rev Date:
Department: Assessment Date: Standard: ISO 9001:2015 QMS Updated
Requirements/ Needs/
QMS Processess / Interested Parties Risk / Opportunity Analysis Primary Action Residual Action
Expectation / Issue Identification

NewRating
Current Rating after
Risks improvement
Quality Management Process

(Negative) / Need
Opportunity Description of further Recommended Action Status
Interested Parties

QMS Process / Interested Requirements / Needs / Expectations / (Positive) Current Control / Methods (SOP, WI, PFM Action (tick)
No Risks (Negative) /

Exposure (L / M / H)

Exposure (L / M / H)
Parties / Compliance Obligation Issues (tick) Ref)
Opportunity (Positive)

Probability (O)

Probability (O)
Impact (S)

Impact (S)
Risk
QMS IP Opp. Yes No Recommendation PIC (Name) Effective Date Closed Open
s

page 2 of 3 NEI-F-100-ROAR/Rev.00
ISO 9001:2015 - Risk Rating Guide
Probability of Occurrence Severity of Harm Benefit to QMS / IP

O-5 Frequent S-5 Catastrophic B-5 Excellent

O-4 Probable S-4 Critical B-4 Very Good Improvement

O-3 Occasional S-3 Marginal B-3 Good improvement

O-2 Remote S-2 Reliable B-2 Some improvement

O-1 Improbable S-1 Minor B-1 No significant improvement

RED = Critical - Need immediate attention and action to further reduce the detected impact.

YELLOW = Moderate - Planned action may required through revision to QMS documentation or improvement program as
necessary.

GREEN = Minor - No further action required.

RISK Minor Reliable Marginal Critical Catastrophic


(S-1) (S-2) (S-3) (S-4) (S-5)

Frequent (O-5) 5 10 15 20 25

Probable (O-4) 4 8 12 16 20

Occasional (O-3) 3 6 9 12 15

Remote (O-2) 2 4 6 8 10

Improbable (O-1) 1 2 3 4 5

No significant Very Good


Some improvement Good improvement Excellent
OPPORTUNITY improvement
(B-2) (B-3)
Improvement
(B-5)
(B-1) (B-4)

Frequent (O-5) 5 10 15 20 25

Probable (O-4) 4 8 12 16 20

Occasional (O-3) 3 6 9 12 15

Remote (O-2) 2 4 6 8 10

Improbable (O-1) 1 2 3 4 5

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