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QMS-Process Risk Assessment Example

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Saravana kumar Nagarajan
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72 views2 pages

QMS-Process Risk Assessment Example

Uploaded by

Saravana kumar Nagarajan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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762340094.

xlsx

Mar '19 Jun '19 RPN Dec '19 RPN Jul '20 RPN
Process RPN RPN Change RPN Change RPN Change
Corporate Process 212 57 155 38 20 36 2
Customer Support Process 307 105 202 86 19 68 18
Outsource Control 141 105 36 97 8 87 10
Resource Management Proces 187 96 91 67 29 61 5
R&D Engineering Process 104 98 6 87 11 87 0
Product Delivery Process 133 84 49 76 7 76 0
Continuous Improvement Proc 193 76 117 73 3 56 17
AVERAGE 183 89 94 75 14 67 7
TOTAL 1278 621 656 524 97 472 52
baseline 51% reduction 16% reduction 10% reduction

Risk Assessment Table Risk Yardstick reference


Sev/Occ/Det Risk High 9-10 SEVERITY OCCURANCE DETECTION
Sev/Occ/Det Risk Moderate 7-8 1=not noticeable 1=not foreseeable 1=Failure can't occur
Sev/Occ/Det Risk Fair 4-6 2=barely noticeable 2=not likely in 5 years 2=Failure can't escape
Sev/Occ/Det Risk Low 1-3 3=noticeable to some 3=unlikely in 1 year 3=Redundant checks
4=noticeable to all 4=might occur in 1 year 4=Hard to miss detection
5=some deleterious impact5=likely occurs 1x/yr 5=Automatic inspection
RPN Score Assessment Table 6=significant impact 6=might occur >1x/mo 6=Sometimes miss detect
RPN Score High >300 7=major impact 7=likely occurs >1x/mo 7=Manual inspection
RPN Score Moderate 125-300 8=disruption 8=might occur 1x/wk 8=Often miss detection
RPN Score Low <125 9=serious disruption 9=often occurs >1x/week 9=Not checked
10=irreparable disruption 10=occurs >1x/day 10=Unable to detect

printed on 06/08/2024
Product Delivery Process Risk Assessment

New New New New


Potential Failure Potential Effect Potential Cause Mar 2019 Controls SEV OCC DET RPN June 2019 Controls SEV OCC DET RPM
Bad raw material Work Instruction 1 8 4 7 224 entries show 8 3 4 96
Delayed Delivery, Improper Machine setup Work Instruction 2 8 3 6 144 improvement 8 3 3 72
Cost of Replacement,
Scrap produced Dissatisfied customer, Operator failure to Work Instruction 3 8 4 7 224 actions 8 3 4 96
scorecard monitor/adjust
Machine malfunction Work Instruction 4 8 3 6 144 8 3 4 96
Customer Test Summary, traveler
Fail to identify defects notes 9 3 5 135 9 3 4 108

Cost of Replacement, Machine fault unnoticed final product inspection 9 3 4 108 9 3 4 108
Nonconforming Product Dissatisfied customer,
not detected, but shipped scorecard Failure to review data before
ship deadline 9 5 4 180 9 3 3 81

shelf life Shelf life undefined 9 3 8 216 9 3 3 81

Late shipment Best efforts 8 3 4 96 96


Dissatisfied customer, Single product;
Late Delivery scorecard Shipped to wrong address
single address 8 3 4 96 8 4 3 96
Delay in shipment,
no one notified 9 4 4 144 9 3 3 81

Cost of Replacement, Shipper mistake 8 3 2 48 48


Product damaged or lost Dissatisfied customer,
after shipment scorecard improperly packaged Packaging instructions 8 4 6 192 8 4 3 96
Operator or office personnel
did not follow procedure, or 6 4 6 144 6 4 4 96
Product mispackaged or Dissatisfied customer, accessed wrong record
mislabeled scorecard
Label falls off, smudged 6 3 4 72 72

Production records lost or potenital Audit finding, computer record mishap,


incorrect loss of traceability in misfiled, wrong file name, 6 5 6 180 6 4 4 96
event of incident paper records not scanned
Product does not perform Dissatisfied customer,
as intended in final lost busiiness Unforeseen factor 7 3 6 126 7 3 4 84
application
145.5 88

printed on 06/08/202407:36:13

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