Risk Analysis - Bangalore 190404
Risk Analysis - Bangalore 190404
Risk Analysis - Bangalore 190404
4 Frequently - Monthly Low (4) Medium (8) Medium (12) High (16) High (20) High Risk ≥15 Take immediate actions to eliminate the risk or lower the risk
3 Possible - Every 6 months Low (3) Medium (6) Medium (9) Medium (12) High (15) Medium Risk 5 ~ 14 Take timely action to implement appropriate controls, if feasible
2 Unlikely - Every Year Low (2) Low (4) Medium (6) Medium (8) Medium (10) Low Risk ≤4 Continue the activity
1 Remote - Every 3 years Low (1) Low (2) Low(3) Low(4) Medium(5)
Negligible Low Marginal Critical Huge
1 2 3 4 5
Severity - S
NG part may reach customer Layout inspection plan made and QA Head /
Lay out Inspection Not Done Quality,
1 Quality Assurance resulting complaint & field 4 2 8 Medium followed. Review plan vs actual every
as per plan Business
failure month
Lay out Inspection - Not Ballooning of the dimensions done and
Resulting in customer complaint Quality,
2 Quality Assurance covering all specifications as 5 2 10 Medium all dimensions included in the report
& field failure is expected Business
per drawing
SPC study plan made and followed QA Head /
SPC Not conducted for Can result in customer
3 Quality Assurance Quality 4 3 12 Medium Review plan vs actual every
special characteristics complaints
month
Chances of defective parts 100 % Inspection done for
Characteristics with Cpk
4 Quality Assurance escaping to customer / next Quality 4 3 12 Medium characteristics with Cpk < 1.33.
below 1.33
process
No knowledge about the calibration plan followed
QA Head /
instrument error, Acceptance of
5 Quality Assurance Calibration not done Quality 3 2 6 Medium Review plan vs actual every
defective part, rejection of OK
month
parts
No knowledge about the All instruments & gauges included in the
Instruments / gauges not calibration plan
instrument error, Acceptance of
6 Quality Assurance included in the calibration Quality 3 2 6 Medium
defective part, rejection of OK
plan
parts
Acceptance criteria defined, Error is
Error in instrument and it is verified after calibration and
Acceptance of defective part,
7 Quality Assurance not communicated to the Quality 4 2 8 Medium communicated, procedure defined for
rejection of OK parts
user out of calibration action
periodic calibration, regular checking of
Chances of use Defective Acceptance of defective part,
8 Quality Assurance Quality 4 2 8 Medium gauge / instrument at the beginning of
gauge / instrument rejection of OK parts
the shift.
No knowledge about the MSA plan followed
9 Quality Assurance MSA not done Quality 4 2 8 Medium
measurement system variation
MSA results not meeting the Acceptance of defective part, Reviewed & corrective actions initiated
10 Quality Assurance Quality 4 2 8 Medium
criteria rejection of OK parts
COP test / revalidation not COP test plan made & tests are
11 Quality Assurance Warranty failure Quality 4 1 4 Low
done conducted as per plan
COP test / revalidation Quality, Reviewed & corrective actions initiated
12 Quality Assurance Excessive field failure 4 1 4 Low
failure Business
Test can not be performed as Daily equipment checks are done
13 Quality Assurance Test equipment breakdown Quality 4 1 4 Low
per plan
Test / revalidation personnel Non-conformity in test Testing personnel qualified, Test SOP
14 Quality Assurance Quality 4 1 4 Low
not qualified procedure available.
Test / revalidation procedure Testing personnel qualified, Test SOP
15 Quality Assurance Will not get the correct results Quality 4 1 4 Low
not followed available.
Test / revalidation sample Proper identification, storage system
Wrong sample check, Will not
16 Quality Assurance not properly identified, Quality 4 1 4 Low defined. SOP provided and test
get the correct results
stored, handled personnel are trained.
Process audit plan made & followed
Defective part reaches
17 Quality Assurance Process audit not done Quality 4 2 8 Medium QA Head /
customer
Review plan vs actual every
month
IFBAPL-MR-D-16, Rev 0 Page 1 of 7
IFB Industries Limited
Automotive Motor Division
Risk value Revised Risk Value Risk
Type of Risk Risk category
Resp. & Opportunity/ category
Sl (Quality/ (High/ Proposed Risk Mitigation Resp. &
Activity / Process Issues Risk Current Action Time Improvement Potential, (High/
No. Environment/ Severit Probabi Risk Medium/ action Time Target Severity Probabil Risk
Target if any Index (S Medium/
Health/ Safety) y (S) lity (P) Index Low) QA Head / (S) ity (P)
(S x P) x P) Low)
Review plan vs actual every
Defective part reaches Product audit plan made & followed month
18 Quality Assurance Product audit not done Quality 4 1 4 Low
customer
Process & product auditors Criteria defined & List of product &
In-effective process / product
19 Quality Assurance are not qualified / not Quality 4 1 4 Low process auditors made
audit
competent
Defective part reaches Changes are implemented as per QA Head /
Change implementation not Change implementation
20 Quality Assurance customer, no idea about Quality 4 2 8 Medium procedure after customer approval every
done as per procedure review
suspected lots month
Defective part reaches Changes are implemented as per 4M change rules to be
Temporary changes are not Head-QA /
21 Quality Assurance customer, no idea about Quality 4 2 8 Medium procedure after customer approval displayed & 4M changes to
controlled ongoing
suspected lots be controlled
Nonconforming product Proper identification and training to
Defective part reaches Verification by QA during QA /
22 Quality Assurance handling not done as per Quality 4 2 8 Medium operators
customer patrol inspection Ongoing
procedure
Can escape to customer, COPQ Analysis & corrective action
In-house rejections more Actions to be taken at SQA/
23 Quality Assurance will be high, other assembly Quality 4 3 12 Medium implementation
due to parts supplier end Ongoing
parts get rejected
Analysis & corrective action
In-house rejections more Can escape to customer, COPQ implementation SGA / QC activities to be
24 Quality Assurance Quality 4 2 8 Medium
due to process will be high taken up
Operators and inspectors to
Delay in achieving production Analysis & corrective action be properly trained on QA &
25 Quality Assurance In-house rejections more targets Quality 4 2 8 Medium implementation defects Production
Increase in rework & scrap Highly skilled and on-roll / Ongoing
End of line inspection / testing employees to deputed at
Inprocess inspections Resulting in customer critical stations &
26 Quality Assurance Quality 4 2 8 Medium inspections
skipping complaints & internal rejections
27 Quality Assurance Customer complaints more Quality 4 2 8 Medium Analysis & corrective action
implementation
Customer dissatisfaction
Customer rejection PPM Analysis & corrective action
28 Quality Assurance Rejection of parts Quality 4 2 8 Medium
more implementation
Loss of business Review by QA Head & top
29 Quality Assurance Repeated complaints Quality 4 2 8 Medium Analysis & corrective action QA Head /
management,
implementation every
Carry out proper analysis &
Increased costs, Analysis & corrective action month
Warranty issues in few implement CAPA
30 Quality Assurance Loss of reputation, Quality 4 3 12 Medium implementation
products
Impact on vehicle sales
Reduction in profits, increased Analysis & corrective action
31 Quality Assurance Higher COPQ Quality 4 3 12 Medium
material cost implementation
Warranty parts not available Analysis & corrective action Request customers to Head-QA /
32 Quality Assurance CAPA cannot be implemented Quality 4 3 12 Medium
for analysis implementation provide parts ongoing
Parts are not checked 100% Analysis & corrective action QA to verify before Head-QA /
33 Quality Assurance Increased reworks Quality 4 2 8 Medium
after rework implementation handover to production ongoing
Pre-despatch inspection not Rejections may escape to Inspection standards provided
34 Quality Assurance Quality 4 1 4 Low
done customer
Pre-despatch inspection Inspectors not aware of check
35 Quality Assurance Quality 4 1 4 Low
standard not available points
Increased rejections, increased Close follow up, Review during MRM
Financial, QA Head /
CA/PA not taken / delayed / complaints, customer Complaint / issue Tracking
36 Quality Assurance Quality, 5 2 10 Medium every
CA/PA not taken effectively dissatisfaction, Repeated sheets review
Business month
complaints
Control of documents not defects may be produced due to Document control effective
37 Quality Assurance Quality 3 1 3 Low
done wrong reference
Sufficient resources not Suffient resources available Review annually and
Unable to check product
38 Quality Assurance available for inspection, Quality 4 1 4 Low provide resources as Head-QA
conformity
measurement & testing necessary
Communication of defects/ Non-effective control of defects, Communications through meetings,
39 Quality Assurance quality requirements not recorrence of defects & Quality 4 2 8 Medium emails, phone, quality alert displays
given to the concerned complaints
Chances of rejection at in-house Additional checks when deviations are Additional checks when QA /
40 Quality Assurance Deviations in parts Quality 4 2 8 Medium
& customers acepted deviations are acepted Ongoing
Corrective actions are taken propmptly
Corrective/preventive Recurrence of the
41 actions not taken for Quality 4 1 4 Low
nonconformity
Corrective nonconformities in product,
Preventive actions process, LOI, Test failure,
MSA, SPC, product audit /
IFBAPL-MR-D-16,process
Rev 0 audit Page 2 of 7
IFB Industries Limited
Automotive Motor Division
Risk value Revised Risk Value Risk
Type of Risk Risk category
Resp. & Opportunity/ category
Sl (Quality/ (High/ Proposed Risk Mitigation Resp. &
Activity / Process Corrective/preventive
Issues Risk Current Action Time Improvement Potential, (High/
No. Environment/ Severit Probabi Risk Medium/ action Time Target Severity Probabil Risk
actions not taken for Target if any Index (S Medium/
Health/ Safety) y (S) lity (P) Index Low) (S) ity (P)
Corrective nonconformities in product, (S x P) x P) Low)
Preventive actions process, LOI, Test failure,
MSA, SPC, product audit / Corrective actions are taken propmptly
Customer complaint, field
42 process audit Quality 4 1 4 Low
failure, etc
No knowledge about the risks & Risk analysis is done. Reviews are done
delay in identification of the risk for changes & or once in a year
Risk analysis not done & not mitigation activities, can affect Business,
156 Risk analysis 4 2 8 Medium
reviewed for changes both internally as well as quality
customers & other interested
parties
Contingency plan not made Contingency plan made &
& reviewed, concerned Customer will be affected & may Business, communicated, wherever feasible they
157 Contingency plan 4 2 8 Medium are tested
personnel not aware of the penalize quality
contingency plan
Necessary resources All softwares and suffiient no of
(computers, softwares, computers & servers & email
Can not meet customer communication system available
158 IT server, email Quality 4 1 4 Low
requirements
communication) not
available
Can not meet customer Data is stored in servers with regular
159 IT Data loss requirements and internal Quality 4 1 4 Low back ups taken, Regular security
requirements scanning & antivirus upgradation