Risk Register

Probability (of risk occurring)

# Process Risk
Likelihood

1 All Processes Not satisfy client Unlikely to occur

2 Sampling Not reaching to the site on time/Not available as requested by the client Unlikely to occur
3 Tagging Not identify proporly the sample as well identified by the client Unlikely to occur
4 Checking client requirement Not understand client request Unlikely to occur
5 Receiving samples Working time not match client working time / Incompetent Persons / Loose Sample Unlikely to occur
6 Testing Technical Mistake / Not matching client's request / Delay Somewhat likely to occur
7 Reporting Technical Mistake / Not matching client's request / Delay Likely to occur
8 Encoding Typo Error / Delay Somewhat likely to occur
9 Reviewing/Approving Report Report still contain Errors / Delay / Overloading Somewhat likely to occur
10 Submitting Wrong list of distribution / Delay Unlikely to occur
11 Archiving No document information Unlikely to occur
12 Purchasing Not matching technically / Delay / Quantity not sufficient Somewhat likely to occur
13 Recruitement Not skilled person / Communication difficulties / Delay Unlikely to occur
14 Controlling samples Sample disposed before date / Bad controlling condition / Sample not identified Unlikely to occur
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 Doc. Ref.:ISO/DOC/RiskR
isk Register Edition: 001

bability (of risk occurring) Consequence (if risk is encountered)

Mitigation Plan
Potential Loss of Potential Harm to
Inability to Meet
Potential Violation of (required for risk factors >10)
Previous Occurrences Contract Terms / May reference external plan document
Contracts User or Patient Regulations
Prob. Reqs
Rating
Has never occurred. 2 High High High None / NA
Has never occurred. 2 Minor Minor None / NA None / NA
Has never occurred. 2 Minor Minor Moderate Minor
Has never occurred. 2 Moderate Moderate High None / NA
Has occurred in past year. 5 Minor Minor Moderate Minor Mitigation Planin technical Department or get more information and sample size from c
Has occurred in past year. 5 High Moderate Minor None / NA Mitigation Planin technical Department or get more information and sample size from c
Has occurred in past year. 5 Very High Moderate Minor None / NA Documented coordination with regards to project specific reporting requirements.
Has occurred in past year. 5 High Moderate Minor None / NA Documented coordination with regards to project specific reporting requirements.
Has occurred in past year. 5 High Moderate Moderate None / NA Documented coordination with regards to project specific reporting requirements.
Has never occurred. 2 Minor Minor Minor None / NA
Has occurred in past year. 5 Minor Minor Minor Minor Mitigation plan in technical Dep to provide area and serial number
Has occurred in past year. 5 Minor Minor Minor None / NA Buffering stocks of materials required thru inventory monitoring
Has never occurred. 2 Minor Minor Minor Minor
Has never occurred. 2 Minor Minor Minor Moderate
 Doc. Ref.:ISO/DOC/RiskR
Edition: 001
Page: 1/1

Risk Factor
after
Responsible Due Date Mitigation

number

or get more information and sample size from clients

or get more information and sample size from clients orBuffering stocks
s to project specific reporting requirements.
s to project specific reporting requirements.
s to project specific reporting requirements.

vide area and serial number

hru inventory monitoring
Likelihood Occurrences Potential Violation correction
Cannot occur / not applicable Has never occurred. None / NA None / NA $0
Unlikely to occur Has not occurred in past 10 years. Minor None < $100,000
Somewhat likely to occur Has not occurred in past 5 years. Moderate Possible < $500,000
Likely to occur Has occurred in past 5 years. High Yes > $500,000
Very likely to occur Has occurred in past year. Very High Yes > $1,000,000

Customize list
entries as see fit.
reputation score RISK RATING LIMIT: Processes
None 1 10.0 All Processes
Minimal 2 Sampling
Moderate 3 Tagging
Severe 4 Checking client requirement
Very severe 5 Receiving samples
Testing
Reporting
Encoding
Enter the minimum Risk Reviewing/Approving Report
Rating score which will Submitting
trigger mitigation action. Archiving
Purchasing
Recrutement
Controlling samples

Customize list of
internal
processes here. Other
Mitigation
) Plan Mitigation Plan
(required
May referencerisk
for (required for risk factors >10)
factors
external> plan May reference external plan document
document