Reference Points

Manpower, Machine/Tools, Method / System, Material, Market, Marketing, Productivity, Supply chain, Capacity
Experience, Patents, Environment, Business, Competitive, Profit/Turnover, Moral, Transperancy, Professionalism
Customer relationship,Visual Management
QMS

LEGAL ISSUES, EMERGENCIES, SAFETY ISSUES, INCIDENTS,Mockdrills,Emergency Preparedness & Response,Safety

Incidents,Mitigation Effectiveness, New Hazards & Risks,Use of PPE,First Aid Data, Unsafe Equipments,Participati
Supplier,Safety Related Trainings,Visual Management,Ergonomics
H&S

MAN, MACHINE, USE OF NON HAZARDOUS MATERIAL, METHOD, ENVIRONMENT, AIR POLLUTION, WATER POLLU
POLLUTION, DEPLETION OF NATURAL RESOURCES, BIO DIVERSITY, ECOSYSTEM, ENERGY USAGE, NON CONVENTI
EMS EMERGENCIES, SAFETY ISSUES, INCIDENTS,Visual Management

Sr. No. Type Standard Description

QMS Manpower-Skilled manpower( trained,well educated,energetic,experinced).

QMS Method-Process defined Inspection.
QMS Document-WI,SOP,Checklist,Quality plan,Daily moring meeting(Quality Accoun
QMS Machine/Tools- Quality tools,Digital Calibrated equipments.
QMS Technology- SAP system with QM,Mail,Telephone,Quality whatsapp group,CRM
QMS Professionalism-Staff Puntuality,Timely worked without delay,Problem solving
QMS Strategies- Effective Calibartion & validation,Effective monitoring data through
QMS Visual management- Strong visual aids,Quality Alert,Do & Donts,Lesson Learnt.
QMS Trained manpower - Fire Fighting & First Aid
QMS Barcode tracebility
QMS CRM software for addressing customer issues.
QMS Minitab analytical software.
1 STRENGTHS
QMS Relationship with workers
QMS Training calendar updation for FY-21 & 22, FY-22 & 23 to workmanship issues
QMS Improvement projects
H&S Availability and use of PPE
H&S Safety Related Trainings- Knowedge of fire fighter , First aid ,
H&S Saftey observation monitoring on accountablity board.
H&S Visual Management w.r to COVID'19
H&S EMERGENCIES- First aid & Fire fighting trained manpower,Fire extinguisher.
EMS No paper waste generated due to usage of SAP
 EMS Less Electricity consumed due to more electrical test conducted at vendor plac
EMS No soil pollution observed due to no test conducted for oil at factory
EMS No noise pollution observed due to electrical test conducted at vendor place

QMS Space for material under D3 inspection

2 WEAKNESS
QMS Delay in defective material analysis due to component not received on time.
H&S Safety awareness at supplier
QMS Awareness of Analytical tools like Six sigma
QMS Material defects - FIFO at stores not effectively maintained
QMS Advanced training on product

QMS Digitilization calibration process - Chances of skipping instrument from calibrati

3 OPPORTUNITY
QMS Tools and equipments set up
QMS IMS Training
H&S Legal Activities & participation

H&S Short supply of material to customer.

4 THREATS
QMS Complete historical data of product and process is not available.
QMS Reduction in customer complaints - Reduce DOA cases, in warranty faliure,Zer
Note - Review Frequency Once in 6 months.

Prepared By :
nts
oductivity, Supply chain, Capacity, Knowledge, Automation, Technology,
al, Transperancy, Professionalism, Finance, Strategies, Customer base,

y Preparedness & Response,Safety Audit,Lost Hours due to

ta, Unsafe Equipments,Participation of Workers,Safety Issues at

NT, AIR POLLUTION, WATER POLLUTION, NOISE POLLUTION, LAND / SOIL

ENERGY USAGE, NON CONVENTIONAL ENERGY USE, LEGAL ISSUES,

Description

ducated,energetic,experinced).

ly moring meeting(Quality Accountablity board)etc.

ed equipments.
hone,Quality whatsapp group,CRM.
ed without delay,Problem solving.
Effective monitoring data through rediness plan
y Alert,Do & Donts,Lesson Learnt.

s.

Y-22 & 23 to workmanship issues to shop floor employees

ghter , First aid ,

ity board.

d manpower,Fire extinguisher.
AP
ical test conducted at vendor place
ducted for oil at factory
test conducted at vendor place

mponent not received on time.

ly maintained

skipping instrument from calibration plan

ess is not available.

DOA cases, in warranty faliure,Zero defect.

Approved By :-
 INTERNAL AND EXTERNAL ISSUES

Current Status
S.NO Internal/ external Concern Issues Department Remarks
Positive / Negative

1 Cultural Not applicable

2 Social Not applicable
3 Political Not applicable
1.Plastic Ban is initiated
4 Legal Restriction about plastics Stores,Logistics Negative 2.The progress is monitored through
platric ban audit
5 Financial
Introduction of new
6 Technological R&D, Production Positive
products/techniques
7 Economic Economic slow down Sales & Marketing Negative

Rain Water is pumped out & cannot be

8 Natural surroundings Excessive Rain Production Negative
harvested due to salt water intrusion

Market competition
9 whether international, national, Introduction of new brands Sales & Marketing Negative
External regional or local
10 Introduction of new competitors Introduction new brands Sales & Marketing Negative
11 Contractors, subcontractors Fulfilling of EHS requirements All departments Positive

12 Suppliers Fulfilling of EHS requirements Production Positive

13 Partners and providers Not applicable
14 New technologies Not applicable
15 New laws New EHS legal requirements HR Positive
16 Emergence of new occupations Not applicable
New knowledge on products and their
17 Not applicable
effect on health and safety;
18 Key drivers and trends Not applicable
Relationship with external interested
19 Communication HR & Procurement Positive
parties

Governance, organizational structure, Changing

20 HR Positive
roles and accountabilities organization/Circumstances

Developing and improving

21 Policies, objectives and the strategies HR Positive
objectives
Training for enhancing
22 Capabilities All departments Positive
capabilities

Information systems, information flows Updating and maintaining the

23 All departments Positive
and decision-making processes information

Internal Introduction of new products, materials,

24 services, tools, software, premises and Upgrading skills All departments Positive
equipment
25 Relationship with workers Employee issues HR Negative
26 Culture in the organization Safety working culture All departments Positive
Standards, guidelines and models adopted
27 Continual updation All departments Positive
by the organization
form and extent of contractual Compliance to terms and
28 HR Posotive
relationships agreements
29 Working time arrangements; Excessive working hours HR Negative
30 Working conditions Unsafe conditions All departments Negative

Internal and Environmental conditions related to Maintaining the parameters Monitoring & Measurement analysis
31 Maintenance Positive
External climate, air quality, water quality, land use within the TNPCBlimit register is maintained

Internal and Maintaining the parameters Monitoring & Measurement analysis

Existing contamination Maintenance Positive
External within the TNPCB limit register is maintained
32

Internal and Maintaining the parameters Monitoring & Measurement analysis

Depletion of Natural resource Maintenance Positive
External within the limit register is maintained
33

Internal and Maintaining the parameters Monitoring & Measurement analysis

Biodiversity Admin Positive
External within the limit register is maintained
34

Internal and
Calibration related to suppliers Continual updation Quality Positive Equipment calibration register
External
35
 CONTEXT,
NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

Internal/
Sl.no Interested party Needs & Expectations Why Remarks 9001 14001 45001
External
1 Legal and regulatory authorities External To follow the legal requirements Need √ √ √
2 Internal/ external Internal Fulfilling of all business requirements Need √
Following of all environmental guidelines while supplying
Need √
materials.
3 Suppliers External
Guide and provide emergency procedures to react in case of
Need √
emergency
4 Contractors and Subcontractor External Safe working environment Need √
5 Workers’ representatives Internal Safe working environment Need √
6 Workers’ organizations (trade unions) and Internal Safe working environment Need √
employers’ organizations

Expectation &
7 External Profitable business & operation √
Need
shareholder
8 Clients External safe and environmental friendly products Need √
9 Visitors External Safe conditions Need √
Local community and neighbours of the
10 External Risk /Accident/Disaster free operation Need √
organization and the organization
11 General public External Risk free operations Need √ √
12 Customers External Risk free production and compliance Expectation √ √
13 Medical and other community services External Support during medical emergencies Need √
14 Media External Smooth relation and updates Need √
15 Academia External Continual improvement √
16 Business associations External Fulfilling of legal and business requirements Need √
17 Non-governmental organizations (NGOs) External Fulfillment of EHS legal requirments √ √

18 Occupational health and safety External √

organizations Provision of safety and health working environment.
Need
Occupational safety and health-care Continually improving safety of the place.
19 External √
professionals
Safety precautions system followed during Internal /
20 √ √
COVID'19 External All safety measures related to COVID'19 are advised to all Need
employees
 6.1 - RISK AND OPPORTUNITIES REGISTER Doc #

RISK ASSESSMENT PURPOSE - CHANGE IN PRODUCT / PROCESS/ INFRASTRUCTURE / ACTIVITY/ MATERIAL / LEGAL ISSUE / CUSTOMER ISSUE / REJECTION/ OTHER Rev # 0(06-02-2020)
Note : Please add all points from SWOT, Context Matrix, Needs and Expectations,Internal/External Issues Page # 1 Of 1
Process Name - Quality Department
Severity
Occurrence
Sr. No. Issue or Requiments Type - Risk (R) / Opportunity (O) Internal / External Reference S,W,O,T Description (for R and RPN = Sev X Occ High/Low (Potential Impact) Action Plan Remark
(Only for Risk)
O)
Criticle to inspect material & Non
1 Space for material under D3 inspection R Internal SWOT W 5 3 15 High Dedicated separate location for D3 inspection. Closed
conformance(D3) material may mixed with
new material.

1. Review of components failure and status in CFT

2 Delay in defective material analysis due to component not R Internal SWOT W Analysis delay due to site faulty material 5 4 20 High meeting. Closed
received on time. not recived on time 2. Dedicated person assigned to pull the material
from site and communicate to all concern.

1. Supplier audit sheet updated with OH&S

3 Safety awareness at supplier O External SWOT W May be harmful for human being. 5 NA 5 High requirements . Closed
2. Awareness through frequent visit and audit at
supplier end.

4 Advanced training on product O Internal SWOT O Wrong decisions due to poor knowledge 3 2 6 Low Training plan to enhance product knowledge in place. Closed

1. Calibration digitization project started.

Use of uncalibrated instrument may lead 2. Reminder for before calibration by aoto generated
5 Digitilization calibration process - Chances of skipping R Internal SWOT O to wrong results. 5 NA 5 Low mails from calibrating agency will be given. Inprocess
instrument from calibration plan Instrument & meters shall be calibrated at 3. Onsite calibration to eliminate chances of
stipulated interval instrument skipping from calibration.
4. Online calibration TC traceability.

6 Tools and equipments set up O Internal SWOT O NA 3 3 9 Low Tools procured. NA

To create awareness of the requirements

of the standard. Rather, your ISO
awareness training is intended to educate
your team on how their specific duties tie
into your QMS and how their solid
understanding of their responsibilities and
7 QMS Training O External SWOT O their competency in performing their 5 3 15 High Training plan to enhance QMS knowledge is in place. Closed
assigned duties play a critical role in the
quality of your company’s deliverable.

It’s not about awareness of ISO – it’s the

broad awareness of how each employee
makes their mark on quality.

1. Actions to reduce material rejection are in

8 Material rejection R Internal SWOT T COPQ increases 5 4 20 High progress. Inprocess
2. PDI started at supplier.
3. CTQ training at supplier given.

9 Short supply of material to customer. O Internal SWOT T NA 2 2 4 Low Barcoding traceability project implemented to track Inprocess
the dispatched productes.

10 Manpower - Skilled manpower( trained,well NA Internal SWOT S NA NA NA NA NA NA NA

educated,energetic,experinced).
11 Method - Process defined Inspection. NA Internal SWOT S NA NA NA NA NA NA NA

12 Document Control - WI,SOP,Checklist,Quality plan,Daily O Internal SWOT S NA NA

morning meeting(Quality Accountablity board)etc.

13 Technology- SAP system with QM module NA Internal SWOT S NA NA NA NA NA NA NA

14 Experience- Experienced manpower. NA Internal SWOT S NA NA NA NA NA NA NA

15 Professionalism - Staff Punctuality,Timely worked without NA External SWOT S NA NA NA NA NA NA NA

delay,Problem solving.

16 Strategies- Effective Calibartion & validation,Effective NA Internal SWOT S NA NA NA NA NA NA NA

monitoring data through rediness plan

17 Visual management- Quality Alert,Do & Donts,Lesson Learnt. NA Internal SWOT S NA NA NA NA NA NA NA

18 Trained manpower - Fire Fighting & First Aid NA Internal SWOT S NA NA NA NA NA NA NA
19 Availability and use of PPE NA External SWOT S NA NA NA NA NA NA NA

20 Safety Related Trainings- Knowedge of fire fighter , First aid , NA Internal SWOT S NA NA NA NA NA NA NA

21 Saftey observation monitoring on accountablity board. NA Internal SWOT S NA NA NA NA NA NA NA

22 Complete historical data of product and process is not O Internal SWOT T NA 3 3 9 NA NA NA

available.

24 CRM software for addressing customer issues. NA Internal SWOT S NA NA NA NA Low Customer isssues has been captured with image Closed
evidence and upload in server for analysis

25 Minitab analytical software. NA External SWOT S NA NA NA NA NA NA Closed

26 Digital instrument used for inspection. NA Internal CM S NA NA NA NA NA NA NA

27 Supportive staff NA Internal CM S NA NA NA NA NA NA NA

28 Praticipation in CSR activity. NA Internal CM S NA NA NA NA NA NA NA

29 Use of paper for records NA Internal CM S NA NA NA NA NA NA NA

30 Awarncess of corporate values. NA Internal CM S NA NA NA NA NA NA NA

1. Training plan to enhance analytical knowledge is in

31 Awareness of Analytical tools O Internal CM W need analytical training 2 1 2 Low place. Inprocess
2. Minitab training to be planned.

32 Reduction in customer complaints - Reduce DOA cases, in O Internal CM T DOA cases 4 3 12 Low 1. Conduct CFT Meeting for field failure. Closed
warranty faliure,Zero defect. 2. Autometed testing software to be implemented.

33 Continuous performance development review through goals. NA Internal CM S NA NA NA NA NA 1. KRA implementation for departmental objectives Closed

34 System handover to quality with issues / problems by producti O Internal N&E S Procedure for system handover 3 1 3 Low 1. Procedure defined. Closed
2. Implementation of visual inspection team.

35 Material defects - FIFO at stores not effectively maintained O Internal N&E w NA NA NA NA NA 1. Procedure defined. Inprocess
2. Continuous training plan.

36 Legal Activities & participation O Internal/External N&E O NA NA NA NA NA NA NA

37 Relationship with workers O Internal SWOT S If any employee required support w.r to 3 1 3 Low 1.Training provided for workmanship issues as per Closed
Work manship issues/Training ) the A3 Project calendar

Based on the plan,training provided to

Training calendar updation for FY-21 & 22, FY-22 & 23 to Internal SWOT S shop floor employess or if any emergency 3 1 3 Low 1.As per training plan,training provided (Ref Inprocess
workmanship issues to shop floor employees training w.r to customer complaints ,it is Document:Training calendar on monthly basis)
given as per the timeline
38 O

1.OCP's(Operational Control procedures is displayed

at designated locations to avoid the gap.
Visual Management w.r to COVID'19 Internal SWOT S Established COVID'19 related documents 2 2 4 High 2.Visual system is implemented effectively during Closed
to the entire organization COVID'19 situations.
(E.G: ES.OC.28 OCP for Disinfection to ES.OC.36 OCP
for office)
39 O

ES.FO11-Daily Check list - COVID'19 is established.

(E.G)1.Thermal screening shall be done before
Safety precautions system followed during COVID'19 Innternal/ N&E S Monitoring system w r to COVID'19 is 5 1 5 Very High allowing entry into factory for each Employee/Visitor Inprocess
External effectively implemented and value is monitored & recorded.
2.Availability of hand-sanitizers at work place area,
Canteen area, water cooler area etc.

40 O

Improvement projects Internal SWOT S Monthly quality review meeting 3 1 3 High Monthly review monitoring. Inprocess

41 O
REVIEWED DATE: 03-04-2024
 RATING MATRIX
RATING SEVERITY OCCURANCE
1 NONE NONE
2 LOW LOW
3 MEDIUM MEDIUM
4 HIGH HIGH
5 VERY HIGH VERY HIGH

SIGNIFICANCE MATRIX
POTENTIAL IMPACT IMPACT OBJECTIVE/ ACTION PLAN
OPTION 1- ≥ 90 % OF HIGHEST ACHIEVED HIGH OBJECTIVE/ ACTION PLAN REQUIRED

OPTION 2- CUSTOMER / SAFETY/ LEGAL ISSUE, HIGH OBJECTIVE/ ACTION PLAN REQUIRED

OPTION 3- SEVERITY RATING - 5 HIGH OBJECTIVE/ ACTION PLAN REQUIRED

OPTION 4- OCCURENCE RATING - 5 HIGH OBJECTIVE/ ACTION PLAN REQUIRED

OPTION 5- OTHERTHAN OPTION 1 to OPTION 4 LOW NOT REQUIRED

 Revision History
Sr. No. Date Revision Changes Done By
Status with revised target dates