Doc. No.

: TM-ROA-01
Logo Risk and Opportunity Assessment Rev. No.: 00

(Process : Manufacturing) Date : 01/06/17

Team : M/s Rajesh Kumar………………….. Next due Date for review : 01/06/18

Risk Index Risk Mitigation / Resp. & Target Action Results

S. ACTIVITY/ Risk
EVENT RISK ( R) OPPORTUNITY EXISTING COTROL S O = Recommended Action Completion
No. OPERATION Priority Risk Index
SxO (s) date Action Taken S O
SxO

Related to QMS Activity

If BOM is not available, material planning would

All models approved BOM are
1 BOM not be accurate Can create problem in 2 2 4 #2
available in Empro
Organization performance

If sales plan is not available, results in shortage

1 month firm plan & 2 month forecast
2 Sales Plan of material Can create problem in QMS 3 1 3 #2
from Sales every month
performance

Planning would be accurate & time

3 MRP System Manual Planning
would be reduced

Material Planning

Non - OEM BOM frequent Resulting in shortage of material Can create Regular meetings with Sales &
4 3 3 9 #2
changes problem in QMS performance Purchase

If planning is changed, results in non- availability

Regular meetings with Sales &
5 Frequent Changes in plan of material & delay in production Can create 2 3 6 #2
Purchase
problem in Organization performance

Mismatch in physical & If mismatched, dispatch schedule will be delayed A class monthly inventory & quaterly
6 3 3 9 #2
system stock Can create problem in QMS performance invontory for all parts

if Sales forecast is changed, palnning would not

Regular meetings with Sales &
7 Sales forecast / plan be correct Can create problem in Organization 2 3 6 #2
Purchase
performance

Changes in customer Sudden change in volume by customer can

8 2 month inventory stock maintained 3 3 9 #2
demand create problem in QMS performance

Timely achievement of plan would be delayed

9 Availability of manpower Multiskilled manpower available 2 2 4 #2
Can create problem in Organization performance
Production Planning
Timely achievement of plan would be delayed
10 Availability of material Daily shortage meeting with Purchase 3 3 9 #2
Can create problem in QMS performance

Incomplete information would delay in planning

11 Information from Sales FO format available 3 2 6 #2
Can create problem in QMS performance
Delay in quality clearance would lead to stock
Quality clearance in
12 update in Empro will result in Loss or degradation Daily Pending GRIN reports 3 3 9 #2
empro
of secondary function
Production plan not achieced due non availability
13 Material Shortage of material Can create problem in QMS Daily shortage meeting with Purchase 3 3 9 #2
performance

Non-availability of manpower delay in delivery Multi skilled manpower

14 Manpower shortage 3 3 9 #2
Can create problem in QMS performance Provision of over time
Contigency plan for tools
Breakdown of tools & machines, delay in delivery
AMC contract
15 Breakdown will result in Loss or degradation of secondary 3 3 9 #2
Critical spares part list
function
Autonomous Maintenance Checklist
if skilled manpower is not available, chances of
16 Skilled manpower OJT's 4 2 8 #2
creating NG product is more, Key driver to IPC

Can provide tool to all station to

17 Tool availabiity Budget Planning
improve productivity

change in plan will take more time to produce Multi skilled manpower
18 Change in plan 3 2 6 #2
number Can create problem in QMS performance Provision of over time

If material not issue from store on prior day ,

Material not issues from Regular follow up of PPC person with
19 production will stop Can create problem in QMS 3 2 6 #2
store on time Store
performance

Production Planning
 Sub Assy material if sub assembly is not ready, delay in production
20 Production Planning Daily advance planning meeting 2 2 4 #2
readiness can create problem in Organization performance

if BOM is not as per requirement, wrong material

22 BOM mismatching will issue from store & leads to delay in BOM sign-off b/w Sales & Customer 4 2 8 #2
production, Key driver to IPC

if part number change in BOM frequently lead to

23 Frequent part no change ECR/ECN 3 2 6 #2
delay Can create problem in QMS performance
 more time consumed to repir & production plan
24 Rework/ Repair Incoming Inspection 2 2 4 #2
will suffer will result in Annoyance
If space is not available change over time
Space for keeping Semi
29 incraeses Can create problem in Organization Space defined for semi FG product 2 2 4 #2
FG products
performance
If packaging planning not done, FG material will
30 Aligment with packaging stock on assy line Can create problem in QMS Daily morning meeting 3 2 6 #2
performance
Every 6 month maintenance plan to be
To be included in
Assembly trolley introduced which smoothens the Mr. Ramesh
31 Annual Preventive Maintenance Plan preventive maintenance
movement mechanism which helps in increase of Immediate
plan
productivity
If preventive manitenance is not done, chances of
36 Preventive Maintenance Preventive Maintenance Plan 2 2 4 2
NG product will result in Annoyance
If validation is not done in NABL approved lab,
37 NABL Approved Lab then chances of wrong results will result in 3 approved NABL labs available 2 2 4 2
Annoyance
Process validation
If calibrated instruments are not available,
39 Calibrated Instruments chances of wrong results will result in Loss or Calibration Plan 3 2 6 2
degradation of secondary function

If history card is not available, loss in traceability

42 History Card Production Recording register 3 3 9 2
Can create problem in QMS performance

If parts identification is not done, results in higher

43 Parts Identification warranty Can create problem in QMS Warranty format 3 3 9 2
performance

If persons are absent then objective would not be

47 Absenteesm fulfilled Can create problem in Organization Prior information 5 1 5 2
performance

On Job. Training

Poor understanding Can create problem in

48 Work Instruction Prior information 2 2 4 2
Organization performance

results in making of NG product will result in

51 Set up Approval Checksheets 3 3 9 2
Loss or degradation of secondary function

If instruments is not available, difficult to check

Availability of
53 parametrs Can create problem in QMS Master list of instruments 3 3 9 2
Instruements
performance

if calibrated instruments are not available, results

54 Inprocess Calibrated Instruments in wrong results will result in loss or degradation Master list of instruments 3 2 6 2
Inspection of secondary function

Rejection Tag
If control os not available, chances of mixing up
Rejection Bin
55 Control of NG parts with OK parts will result in Loss or degradation of 5 2 10 2
Rejection storage Area
secondary function

If identification is not there, status of parts would

56 Identification be missing will result in loss or degradation of Rejection tag 3 2 6 2
secondary function

If PDI is not done, chances of NG product to

57 PDI customer will result in Loss or degradation of PDI Checksheet 3 2 6 2
secondary function
Final Inspection
 Final Inspection

Product status will not be known / Chances of

Unit identification sticker with brand
59 Identification mixing up will result in Loss or degradation of 3 2 6 2
name pasted inside the unit
secondary function

if packing material is not available, delay in

Availability of packing
61 dispatch Can create problem in QMS Bulk stock 3 2 6 2
material
performance

Ispace is not available then time consumption

62 Space for packing would be more & also chances of mixing up can Area defined for packaging 2 2 4 2
create problem in Organization performance

Packing list is not there, then chances of

63 Packing List shortage of material Can create problem in Approved packing list 2 2 4 2
Dispatch Organization performance
Prior dispatch packing
Clear understanding of packing Mr. Shubham
64 Customer Approval Customer approved packing standard standard to be made &
standards Immediate
approved by customer
 Status of packed part would not be known Can
65 Identification Unit serial no manually mention 3 2 6 2
create problem in QMS performance

Incorrect Packing will result in Loss or

66 Method of packing Packing Standard available & WI 3 2 6 2
degradation of secondary function

Delay in shipment Can create problem in QMS

67 Mode of transport Daily morning meeting with logistics 3 2 6 2
performance

Delay in dispatch if not verified Can create

68 Transport verification Security Checklist 3 2 6 2
problem in QMS performance

Dispatch
Short supply results in extra freight cost Can Regular shortage meeting with
69 Short Supply 3 3 9 2
create problem in QMS performance purchase

Invoice / Packing List / Delay in shipment Can create problem in QMS

70 Daily morning meeting with logistics 3 2 6 2
PDI performance

Objective would not be fulfilled Can create

74 Kaizen & Continual Employee Engagement Monthly Meeting 3 2 6 2
problem in QMS performance
Improvement
process (CIP) KAIZEN / CIP would not get implemented can
77 Management Support Available 3 2 6 2
crate problem in QMS performance

Average

Risk Index
Severity (S) Rank Occurrence (O) Rank
=SXO
Risk----Effect of uncertainty
Almost certain (Very Note 1: An effect is a deviation from the
Key driver for Customer & QMS performance 5 5 25 expected — positive or negative.
high)
Note 2: Uncertainty is the state, even
Key driver to Interested Parties 4 Likely (High) 4 16 partial, of efficiency of information related
to, understanding or knowledge of, an
Can create problem in Organization event, its consequence, or likelihood.
3 Possible (Moderate) 3 9
performance
Can create problem in Functional /
2 Unlikely (Low) 2 4 Risks and opportunities ----
Departmental / Process performance
Potential adverse effects (threats) and
Negligible effect 1 Rare (Very Low) 1 1 potential beneficial effects (opportunities)

Action Criteria :
i) Risk Priority # 1: Either Severity (S) = 5 or Risk Index SXO > 16, Risk Priority #2: if Risk Index SXO ≤ 16;
ii) Action shall be taken on those Risks which have been identififed as Risk Priority #1

F:TM:06, Rev. No. 00, Eff. Date : 01/07/17