6.1 Risk - Opportunity Analysis

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Risk and Opportunity Analysis Last Updated 01.04.

18

Department/Section: Maintenance Process Owner: Maintenance Updation Freq - 6 Months


Sr. Area / Process Risk Impact Current Control Risk Action Opportunities if any Action plan for
No. Plan / T.Dt / Opportunities Risk Factor after Mitigation action
Risk Evaluation Method Risk Treatment Resp / Status identified / T.Dt / implementation
Resp / Status
Severity Likelihood Risk Level Acceptable Mitigate Removal No Severity Likelihood Risk Level
of risk Treatment
source Needed
Critical spares part list NOT No clarity about Manual Excel 4 2 8 √ -- -- -- -- Autogeneration of Auto SMS /
updated spares Updation after communication Purchase Indent
purchase / each issue Generation as
Production loss inventory reach
re-order level /
15th June 19/
Ram Krishan /
Done

Breakdown
1
Process Nonavailability of machine Production Monitoring of 4 3 12 -- √ ----- ----- Maintain and ----- -----
spares Loss /Customer Spare Parts monitor
Dissatisfaction monthly stock
level of
machine spares
on daily basis /
w.e.f / Kiran /
Done

PREPARED BY APPROVED BY

Note - Opporutnity for improvement to be considered even if risk is 'Acceptable' & optional when 'No Treatement Needed'
F/MR/07 Rev No. 01 Rev Date - 01.04.18

Format No. Rev No. 01 Rev Date - 01.12.17


Risk Assessment Matrix
Risk Prioritisation Number = Severity x Likelihood
Severity Table
Pt Severy Level Severity Criteria

5 Critical Impact on Statutory and regulatory requirements


4 Very Serious Impact on interested parties requirements (mainly customer)
3 Serious Impact on product performance
2 Marginal Impact on internal customers (other processes)
1 Negligible Other Impacts

Likelihood Table
Pt Likelihood level Likelihood of Occurrence / Exposure Criteria
5 Frequent Likely to occur weekly
4 Moderate Likely to occur Monthly
3 Occasional Might occur Quarterly
2 Remote Might occur once in 6 Months
1 Unlikely Might occur once in Year

Risk level Determination - 5 x 5 Matrix


severity Criteria
Critical Very Serious Serious Marginal Negligible
(5) (4) (3) (2) (1)

Frequent 25 20 15 10 5
Removal of risk Removal of risk No Treatment
(5) Mitigate Risk Acceptable
source source Needed
20 16 12 4
Moderate 8
Removal of risk Removal of risk Mitigate No Treatment
(4) Risk Acceptable
LIKELIHOOD

source source Needed


6 3
Occasional 15 12 9
No Treatment No Treatment
(3) Mitigate Mitigate Risk Acceptable
Needed Needed
4 2
Remote 10 8 6 No Treatment No Treatment
(2) Risk Acceptable Risk Acceptable No Treatment Needed Needed Needed
5 4 2 1
Unlikely 3
(1) No Treatment No Treatment No Treatment Needed No Treatment No Treatment
Needed Needed Needed Needed

Note - Even, if risk is acceptable, identifiy opportunity for improvement (if any)
Risk and Opportunity Analysis Rev. No. / Date 01/01.04.19

Department/Section: Quality Process Owner: QA Updation Freqy - Six Month


Sr. Area Risk Impact Current Control Risk Evaluation Method Risk Treatment Risk Action Plan / Opportunities if any Action plan for Risk Factor after Mitigation
No. Severity Likelihood Risk Level Acceptable Mitigate Removal of No Treatment T.Dt. / Resp / Status Opportunities Severity action
Likeliho Risk
risk source Needed identified / T.Dt. / Resp / od Level
Status

THIS IS FOR EXAMPLE ONLY


Calibration plan not followed

List of external provider calibration


Actual result not found

Delay for calibration


4

4
1

2
4

8
--


--

--
--

--

--
--

--
--

--
--

--
agencies not available
Equipment
4 Management
(Calibration) No updated list of monitoring and Calibration not done as per 4 1 4 -- -- -- √ -- -- --
Process measuring resources and calibration calibration schedule
schedule.
Not updated history card of monitoring data of calibration unavailable for 4 1 4 -- -- -- √ -- -- --
and measuring resource calibration

Mixing up with OK product Action not effective, customer 4 2 8 √ -- -- -- -- -- --


dissatisfaction, posibility of rework/
rejection.
5 Control of NC
product Operator negligence On Job training should be given 4 1 4 -- -- -- √ -- -- --

Improper analysis of root cause & Action not effective, customer 4 2 8 √ -- -- -- -- -- --


evaluation of data dissatisfaction, posibility of rework/
rejection.
6 Corrective Action
Fails to monitoring of effectiveness of Out put result not ok 4 1 4 -- -- -- √ -- -- --
action.

Dealy for taking corrective action Customer dissatisfaction 4 2 8 √ -- -- -- -- -- --

Customer Improper corrective action. Increase rejection due to wrong 4 2 8 √ -- -- -- -- -- --


7 Complaints action , Customer dissatisfaction
Handling (line /
warranty)
Warranty parts not received for delay in analysis and action / wrong 4 1 4 √ -- -- -- -- -- --
analysis from customer analysis

Failure to identify product-safety Customer dissatisfaction 4 3 12 -- √ -- -- Product-safety -- --


characteristics leading to potential characteristics to be
harm to end customer / life. identified by Design
8 Product Safety
Lack of control over traceability leading Customer dissatisfaction 4 2 8 √ -- -- -- -- -- --
to potential commercial losses

Customer / Self initiated changes are Customer dissatisfaction 4 1 4 -- -- -- √ -- -- --


9 Engineering not determined leading to potential
Specification failure at customer end.
External Provider initiated changes are Customer dissatisfaction 4 1 4 -- -- -- √ -- -- --
10 Control of Changes not determined leading to potential
failure at customer end.
Dispatch of unidentified reworked Customer dissatisfaction 4 2 8 √ -- -- -- -- -- --
part to customer

11 Control of
Reworked Product No monitoring of on-line reworked Customer dissatisfaction 4 2 8 √ -- -- -- -- -- --
parts - potential chances of mix-up
leading to NC part dispatch to
customers.
Repaired part not meeting the form, Customer dissatisfaction 4 2 8 √ -- -- -- -- -- --
Control of function, fitement and reliability
12 Repaired Product requirements.

No engegement of MDT (Multi Action not effective, customer 4 3 12 -- √ -- -- Ensure engagement of -- --


Discplinary Team or CFT) members for dissatisfaction MDT members for
13 Problem Sloving problem solving internal and external
problem solving

No engegement of MDT (Multi Action not effective, customer 4 3 12 -- √ -- -- Ensure engagement of -- --


Discplinary Team or CFT) memberfor dissatisfaction MDT members for
14 Error-Proofing problem solving internal and external
problem solving

learnings from product recall not repetion of failure / loss to 4 1 4 -- √ -- -- -- -- --


captured within organization organization

15 Product Recall

F/MR/15 Rev No. 01 Rev Date - 01.12.17


15 Product Recall
Huge expenses during product Effect CAPEX & brand image of 4 1 4 -- √ -- -- -- -- --
replacements / recall process organization

Audit plan not adhered Non capturing of internal issue / 4 1 4 -- √ -- -- -- -- --


customer issues

Pesonnel NOT competent to carry out In-effective audit leading to missing 4 2 8 -- √ -- -- -- -- --


16 Process & Product the audit of important checkpoints / customer
Audit issues

Process Audit do not cover all the shifts Issues in that shift might be ignored 4 2 8 -- √ -- -- -- -- --

learnings from product recall/ other repetion of failure / loss to 4 1 4 -- √ -- -- -- -- --


incidences not captured within organization
organization

17 Field Return
/product recalls Huge expenses during product Effect CAPEX & brand image of 4 1 4 -- √ -- -- -- -- --
replacements / recall process organization

Scrap parts wrongly mixed with ok Customer complaint / line issue 4 1 4 -- √ -- -- -- -- --


Disposition / product
18
Scrap

PREPARED BY APPROVED BY

NOTE - THE BLUE HIGHLIGHTED IS REQUIRED AS PER CLAUSE NO. 6.1.2.1

F/MR/15 Rev No. 01 Rev Date - 01.12.17

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