6. Product Severity Risk
Category Severity Sever
ity
Score
Very Low No adverse health consequence 1
Low Temporary or reversible impairment (without medical
intervention) / Transient, minor impairment or complaints
2
Medium Necessitates minor medical intervention 3
High Results in permanent impairment of body function or permanent
damage to a body structure / Necessitates surgical intervention
4
Very High Life threatening (death could occur) 5
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7. Product Frequency Risk
Category Frequency Frequen
cy Score
Remote Very unlikely to occur (less than 1 in 10,000) 1
Rare Unlikely to occur (< 1 in 10,000 and > 1 in 1,000) 2
Occasional Occurring at irregular intervals (<1 in 1,000 and > 1 in 100) 3
Frequent Occurring at short intervals (<1 in 100 and >1 in 10) 4
Regular Occurring often (more than 1 in 10) 5
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8. Product Detectability Risk
Category Detectability Detect
ability
Score
Very High Verifiable by operator with standard measuring equipment 1
High Verifiable by trained personal with specialized measuring device
or equipment
2
Medium Verifiable by trained personal with subjective measurement or
highly specialized device or equipment
3
Low Requires outside testing to verify 4
Very Low Cannot be detected without destructive testing 5
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9. Compliance Severity Risk
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Category Severity Severit
y Score
Very Low The findings is limited to one of the Quality system components
that will not impact the product or the quality system
1
Low Internal Department or Audit finding (Minor) that need Quality
System improvement
2
Medium Internal Audit finding (Critical or Major) that require extensive
improvement for not more than one major component of the
Quality System
3
High Results in a repeat of regulatory violation that can lead to loss of
Business (licensing to a specific region), or limited product recall
4
Very High Can result for a massive recall or Warning letter or Consent
Decry or Shut down the business
5
10. Compliance Frequency Risk
Category Frequency Frequ
ency
Score
Remote Isolated event very unlikely to occur again 1
Rare Unlikely to occur , or can occur under very specific or limited
condition
2
Occasional Occurring at irregular intervals by not following the procedure, or
related to a single department or Unit
3
Frequent Quality system noncompliance start occurring due to recent
changes (< 1 years)
4
Regular Noncompliance was occurring due to Quality system setting or
was not updated to comply with the regulatory requirements
5
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11. Compliance Detectability Risk
Category Detectability Detectab
ility
Score
Very High (Department Level) noncompliance was identified internally by
the Unit or Department
1
High (Quality System) noncompliance was detected by the QS which
is capable to identify, verify, trend , or monitor the KPI, and
correct the noncompliance
2
Medium The noncompliance was identified by an Internal Audit or
Management Review.
3
Low The noncompliance was identified by Corporate Audit or
External Organization Audit
4
Very low The noncompliance was found by Regulatory Body such as
FDA, or ISO Audit
5
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14. CAPA Decision
Risk Decision
Product Compliance
High
CriOcal /
Major
Initiate CAPA & HHR Initiate CAPA and evaluate if
HHR is needed
Moderate
Medium
Evaluate if CAPA and or
HHR is needed
Evaluate if CAPA and or
HHR is needed
Low
Minor /
Negligible
No CAPA or HHR are required No CAPA is required
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