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