Grading of Probability/ Occurrence Grading of Impact/ Severity

Scale Meaning Scale Meaning (Delay)

Almost NIL (Never occurred in
1 1
Past) No Impact
Low Chance - Unlikely. Low Impact- delay by 1-2 Hrs./
2 (Occurred in less than 5% of 2 Impact will not pass on up to
cases) customer

Medium Chance- Unlikely. Medium Impact- delay by 24 hrs./

(Occurred in less than 10% of manageable/ Impact may dissatisfy
cases) customer
3 3
High Chance-(Occurred in less High Impact- delay by 3-5 days/
4 4
than 20% of cases) Customer dissatisfied
Extremely serious Problem/ Delay
Almost Certain-(Occurred in
5 5 by more than 1 Week/ Customer
50% of cases)
highly dissatisfied

Risk Gradation
Scale Meaning
<20 Low
20-40 Medium
>40 High

QF/QMS/18
QF/QMS/18/00/01.01.2018

Prepared By: Admn. Head

Approved by: Pla

 Grading of Control/ Detection

Scale Meaning
Available & effective at source (No effect in Quality
1
& Delivery)
Has in-built secondary control / Contingency plan
2 available at In-House (No effect in quality &
delivery)

Control needs human Intervention / Contingency

plan available / can get help from outsourced (No
effect in quality & Delivery)
3
Mechanism in place but lead time to implement is
4
more than 8 Hrs.
Absent or no effective control- Lead time to
5 implement more than 2 working days- customer
dissatisfied

Prepared By: Admn. Head with Core Team

Approved by: Plant Head

 Premier Seals (India) PVT. LTD

Risk Assessment and Management

Production

Cause of Risk/ Reason

Control / Prevention
Impact/ Severity (I)

Current Process
Occurrence (P)
Probability/
Detection/
Sr. No. Risk Event :Consequence Effect of Risk
Control ©

1. Customer
1. Schedule V/s.
schedule not
dispatch
1 No production plan 1. Delay dispatches reviewed. 2.
monitoring
Schedule not
record
monitoring

3 2 3

1. Capacity
1. In-proper planning 2.
1. Not fulfilment of customer Daily production
2 Over commitment schedule / planning 3.
requirements planning feasibility Customer
review schedule
monitoring
4 3 3
 1. Non fulfilment of
1. No daily 1. Written
3 Vague /incomplete Instruction production plan 3. Not product plan
meeting customer schedule production plan

3 3 3

1. Only
controlled copy
doc. displayed
2. Competent
programmer 3.
1. Wrong process Competency
sheet/ control plan validated at the
1. Production of NC. Products displayed 2. Wrong/ time of
Errors in manufacturing &
4 2. N.C. products dispatched Old drawings issued interview 4. 1st
testing of WIP products 3. Incompetent QA piece In-process
to customer
person 4. Purchase & final
order not reviewed inspection is in
place 5.
Documents
issue control
record
maintained.

4 3 3
 1. Only
controlled copy
doc. displayed
1. Wrong process 2. Competent
sheet/ control plan programmer 3.
1. Production of NC. Products displayed 2. Wrong/ Competency
Misunderstanding of
5 2. N.C. products dispatched Old drawings issued validated at the
customer requirements 3. Incompetent QA time of
to customer
person 4. Schedule interview 4.
order not reviewed Customer
schedule v/.s
delivery
monitoring.

4 3 3

1. Packing
1. Packing standard standard
Mismatch between packing 1. Wrong packing 2. Parts not communicated defined during
6 2. Packing material PPAP stage. 2.
instructions damaged not available in Inventory
stores monitoring by
store keeper
4 3 3

1. Invoice made
1. Violence's of legal 1. Manual entry 2. in ERP/ Tally 2.
Wrong taxation or address or
7 requirements 2. Wrong Wrong data entry in Data entry as
improper documents ERP/ Tally per purchase
delivery
order
4 3 3
 1. Non fulfilment of 1. No daily
Production plan not Production plan
8 production plan 3. Not production plan
communicated down the level made
made & issued
meeting customer schedule
3 3 3

1. Customer
1. Schedule V/s.
schedule not
dispatch
9 No production as per plan 1. Delay dispatches reviewed. 2.
monitoring
Schedule not
record
monitoring

3 2 3

1. Customer
schedule not 1. Schedule V/s.
Delay in dispatches/ Failure in 1. Customer dissatisfied 2. reviewed. 2. dispatch
10 Schedule not monitoring
on-time delivery Line stoppage monitoring 3. record 2. Daily
Production plan not production plan
made
4 2 3

1. Customer
complain
1. Customer handling
complaint not logged mechanism
Increase in customer 1. Customer dissatisfied. 2. Issue defined in QMS.
& attend. 2. Issue not
11 not get closed in stipulated time. 3.
complaints Line stoppage. review regularly 3. In 2. 8 'D' analysis
proper root cause & closure
analysis & CA. monitored
against
complaints.

4 3 3
 1. Process
1 Process Validation validation done
for each
products 2. Skill
1. Process matrix
validation not done evaluated for
Lack of awareness of Process 2. Process operators 3.
1 1. N.C. products produced validation chart not Process chart
validation
displayed 3. Skill displayed
matrix not through control
4 evaluated 2 plan 3

Inadequate competency 1. N.C. products produced 2. 1. Competency

2 matrix & skill
validation of operators Customer Complaints
1. Competency matrix defined
4 criteria not defined 3 for operators 2

1. N.C. products produced 2. 1. Irrelevant 1. On-job

3 Improper operator training
Customer Complaints training topics 3. training 2.
Training plan not Training plan as
4 made 3 per skill matrix 3

Identification

Incoming, WIP & finished 1. Area not 1. Identified

1. Processing of rejected demarcated 2. ID with tags 2.
1 parts not identification by
parts 2. Mix-up tags not defined in Area
Tags
3 QMS 3 demarcated 3
1. Rejected parts dispatched 1. Area not 1. Identified
Identification label not puts demarcated 2. ID with tags 2.
2 to customer 2. Traceability
on finished parts tags not defined in Area
not maintained
5 QMS 3 demarcated 3

Preservation
 1. Racks & Bins
made 2. Rust
1. Rusty/ damage material 2. 1. Proper storage preventive oil
1 In-proper storage of materials
Material detoriate facility not provided used for metal
parts whenever
needed
4 3 3

PSIPL/QMS/21/00/01.01.2018
Prepared By: DH Production

Approved by: Plant Head

LTD Updated On : 01.01.2018

ment

Residual Risk Assessment

Impact/ Severity

Occurrence (P)
Residual Any Review

Probability/
RPN Recommended Opportunities

Detection/
Control ©
Risk Gradation Mitigation RPN Risk Remarks (Ref.
=PxIxC Action identified ref
= P x I x Gradation MRM MOM)

®
C

1. On-time delivery
performance
monitoring 2.
Customer data for
delivery
performance
1. Daily
18 Medium production plan 0

1. Daily
monitoring of
customer 1. Plant capability
schedule & planning
delivery
requirement
36 Medium 0
 1. Daily
monitoring of
customer
schedule &
delivery
27 Medium requirement 0

1. 1st piece / In-

process inspection
report 2. Daily 1. KPI monitoring
production plan
V/s. Actual

36 Medium 0
 1. 1st piece / In-
process inspection
report 2. Daily
production plan
V/s. Actual

36 Medium 0

1. Displayed at 1. Minimum
various station inventory level 2.
2. Stock register Product audit

36 Medium 0

Latest ver. Of
ERP/ Tally

36 Medium 0
 1. Daily
monitoring of
customer
schedule &
delivery
27 Medium requirement 0

1. On-time delivery
performance
monitoring 2.
Customer data for
delivery
performance
1. Daily
18 Medium production plan 0

1. On-time delivery
performance
1. Daily monitoring 2.
monitoring of Customer data for
customer delivery
schedule & performance
delivery
24 Medium requirement 0

1. Written Displayed at Various

communication & Location and
CC to all. Available on LAN/

36 Medium 0
 0

Criteria for
validation &
1. Displayed revalidation defined
near every
24 Medium machines 0

Validation &
1. Process revalidation criteria
24 Medium validation report 0 in QMS

1. Annual
36 Medium training plan 0

0
Parts with ought
1. Procedure for having ID label
Identification & treated as suspect
traceability products. FIFO
27 Medium 0 System.
Parts with ought
1. Procedure for
Ensure PDIR for every having ID label
Identification &
lots treated as suspect
traceability
45 High 5 3 2 30 Medium products. F

0
 5 'S' system
followed.

36 Medium FIFO System 0

tion

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