Risk R

# Process Risk

1 All Processes Not satisfy client

2 Sampling Not reaching to the site on time/Not available as requested by the client
3 Tagging Not identify proporly the sample as well identified by the client
4 Checking client requirement Not understand client request
5 Receiving samples Working time not match client working time / Incompetent Persons / Loose Sample
6 Testing Technical Mistake / Not matching client's request / Delay
7 Reporting Technical Mistake / Not matching client's request / Delay
8 Encoding Typo Error / Delay
9 Reviewing/Approving Report Report still contain Errors / Delay / Overloading
10 Submitting Wrong list of distribution / Delay
11 Archiving No document information
12 Purchasing Not matching technically / Delay / Quantity not sufficient
13 Recruitement Not skilled person / Communication difficulties / Delay
14 Controlling samples Sample disposed before date / Bad controlling condition / Sample not identified
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
 Risk Register
Probability (of risk occurring) Consequence (if risk is encountered)

Potential Harm to User or Inability to Meet Contract Potential Violation of

Likelihood Previous Occurrences Potential Loss of Contracts
Patient Terms / Reqs Regulations
Prob.
Rating
Unlikely to occur Has never occurred. 2 High High High None / NA
Unlikely to occur Has never occurred. 2 Minor Minor None / NA None / NA
Unlikely to occur Has never occurred. 2 Minor Minor Moderate Minor
Unlikely to occur Has never occurred. 2 Moderate Moderate High None / NA
Unlikely to occur Has occurred in past year. 5 Minor Minor Moderate Minor
Somewhat likely to occur Has occurred in past year. 5 High Moderate Minor None / NA
Likely to occur Has occurred in past year. 5 Very High Moderate Minor None / NA
Somewhat likely to occur Has occurred in past year. 5 High Moderate Minor None / NA
Somewhat likely to occur Has occurred in past year. 5 High Moderate Moderate None / NA
Unlikely to occur Has never occurred. 2 Minor Minor Minor None / NA
Unlikely to occur Has occurred in past year. 5 Minor Minor Minor Minor
Somewhat likely to occur Has occurred in past year. 5 Minor Minor Minor None / NA
Unlikely to occur Has never occurred. 2 Minor Minor Minor Minor
Unlikely to occur Has never occurred. 2 Minor Minor Minor Moderate
 Doc. Ref.:ISO/DOC/RiskR
Edition: 001
Page: 1/1

Mitigation Plan
Risk Factor
(required for risk factors >10)
Responsible Due Date after Mitigation
May reference external plan document

number

Mitigation Planin technical Department or get more information and sample size from clients
Mitigation Planin technical Department or get more information and sample size from clients orBuffering stocks
Documented coordination with regards to project specific reporting requirements.
Documented coordination with regards to project specific reporting requirements.
Documented coordination with regards to project specific reporting requirements.

Mitigation plan in technical Dep to provide area and serial number

Buffering stocks of materials required thru inventory monitoring
Likelihood Occurrences Potential Violation
Cannot occur / not applicable Has never occurred. None / NA None / NA
Unlikely to occur Has not occurred in past 10 years. Minor None
Somewhat likely to occur Has not occurred in past 5 years. Moderate Possible
Likely to occur Has occurred in past 5 years. High Yes
Very likely to occur Has occurred in past year. Very High Yes

Customize list
entries as see
fit.
correction reputation score RISK RATING LIMIT:
0 None 1 10.0
<100000 Minimal 2
<500000 Moderate 3
> 500,000 Severe 4
> 1,000,000 Very severe 5

Enter the minimum Risk

Rating score which will
trigger mitigation action.

Customize
list of internal
processes
here.
 Mitigation
) Plan
(required
May for risk
reference
Processes factors >plan
external
All Processes document
Sampling
Tagging
Checking client requirement
Receiving samples
Testing
Reporting
Encoding
Reviewing/Approving Report
Submitting
Archiving
Purchasing
Recrutement
Controlling samples

Other
Mitigation Plan
(required for risk factors >10)
May reference external plan document