PROCESS ANALYSIS

Sl Process Proces Input Output Methods Interfaces Measure of

No s with Performance
Owner (MOP)
1. Results of audits
2. Customer feedback / Customer complaints
3. Process performance & product conformity
Management Review Meeting

4. Status of Corrective & preventive actions

5. Changes that could affect the QMS
6. Follow-up actions from previous MR 1)Improvement of MR Meeting
7. Compliance to all requirements of QMS and its performance QMS effectiveness Management All conducted as
MR

01 trends 2)Product related Review company per planned

8. Status of continual improvement programs improvements Meeting processes intervals(ann
9. Trends in cost of poor quality 3) Resource needs ual plan)
10. Analysis of actual and potential field failure and their impact
11. Continuing suitability of Quality policy
12. Customer Specific requirements – if any new ones
13. Resources required, if any
14. Recommendations for improvement
Achievement
Business plan , process

of
1) Quality Policy All
All HODs
performance and

Key Performance Organization

2) Customer Specific requirements As defined company
02 indicators trends al goals and
processes
objectives

3) Process performance analysis data

Departmental
4) Business plan
OATs
 Measure of
Sl Process Interfaces
Process Input Output Methods Performance
No Owner with
(MOP)
1)Authorized
All documents, Documents
documents
Control of

All HODs
1) Standards Soft & All company 2)Approval of
Master List of documents
03 2) Stat. and Regulatory requirements, Hard copies. processes amended
3) Specifications, document change
4) Customer Specific requirements request

1) Comply to
Control of

All HODs
records

1) All records Soft & All company storage methods

04 2) Requirements (legal, company & Hard copies. processes 2) Legibility
customer) &retrivability
Training and

HOD-HR &

1)Qualified personnel 1)Training planning &

Motivation

1) Training need requirements

HODs

2)Training plans Imparting All Company 1) Training man

2) Competency and skill matrix gaps
05 3)Trained personnel 2) on the job training processes days per employee
3) Customer requirements
Training record
Mfg. Ops & HOD-PE
Infrastructure and
Projects planning

1)Business plan 1)Capacity planning

Infrastructure designed to All company Project execution
2)Budget 2)Feasibility and risk
06 meet requirements processes as per plan
3)Capacity requirements analysis
Sl Process Process Input Output Methods Interfaces Measure of
No Product and Manufacturing process Owner with Performance (MOP)

1)Customer specific requirements

1)Product special characteristics
2)Budget

HOD - Engineering, HOD –

2)Specifications
3) Customer complaints
development process

3)Drawings
4) Project goals
4)Manufacturing process flow chart 2) FMEA MKG, 1) Number of
5) Timing plan
CFT 5)PFMEA 4) SPC PRD customer complaints
6) ECNs
07 6)Control plan 5) PPAP QA & reported
7) Statutory requirements
7)Process approval acceptance criteria 6) RFQ Customers 2) Number of new
8) Targets for productivity, process
8)Feedback of production/ manufacturing projects executed
capability & cost
process non-conformities
9) Experience from previous
9) SOP
developments

1)Order 1)Reduction in
process procurement cost of
1) Purchase request 1)Release of POs 2)Evaluation raw materials
HOD-PUR
Purchase

PPC,
2) Specifications/ drawings 2)Development of suppliers of suppliers 2)Minimizing
PRD,
08 3) Product regulatory requirements 3) Inquiries 3)Material production
QA
4) Customer approved sources 4) vendor audits requirement interruptions with
planning alternate
material/Variant
Sl Process Process Input Output Methods Interfaces Measure of
No Owner with Performance (MOP)

1) Number of items
1) control plan
inspected within
Inward goods

2) Sampling plan PPC,

inspection

HOD-QA
1) Accepted GRNs to stores 24Hrs
1) GRNs from stores 3) Test methods STR,
2) Inspected material 2) Number of inprocess
09 2) Inward material 4) Test certificates PRD,
3) Material inspection rejections due to IGI
samples 5) Specifications PUR
report (Inward Goods
6) Drawings
Inspection)

1)Production plan 1) Dispatch

HOD-PPC
Planning

MKG,
1) Customer orders / 2)Machine utilization 1)Production planning performance
PRD,
10 Sale Orders 3)Materials planning 2)Delivery schedule analysis 2) Production capacity
PUR
2) Plant capacities 4)Dispatch schedules utilization
1) GRNs 1) Adherence to FIFO
1)GRN/Delivery from
2) Accepted material 1) Inventory Management 2) Inventory turnover
HOD-PPC
Inventory

purchase MKG,
control

3) Rejected material to 2) Inventory monitoring rate

2) Opening stocks PUR,
11 supplier 3) Physical verification of stocks 3) Cost of Non –
3)Materials received PRD
4) Stock Register 4) Inspection plan moving
4)Scrap memo
updation items
1) Production schedules
Assembly process
Manufacturing &

1) Visual aids 1) Productivity

2) Raw material PPC,
HOD-PRD

1) Finished Products 2) Procedures 2) Rate of Rejections

3) Customer delivery STR,
2) Updated Production & 3) Work Instructions 3) Rate of Reworks
12 schedules QA,
traceability Records 4) Specifications 4) COPQ.
4) Customer Specific MNT
5) Control plan 5) Defects rate in PPM
requirements
Sl Process Process Input Output Methods Interfaces Measure of Performance
No Owner with (MOP)
1) Percentage Breakdown
1) Preventive Maint. &
1) Equipment in hours
Maintenance

1) Breakdown requests Predictive

good PRD, 2) MTBF

HOD-Plant
2) Spares Maint.(PCE-DPR-) procedure
13 condition STR 3) MTTR
3) Checklist 2) Breakdown maintenance
2) History record 4) Preventive maintenance
4) Work Instructions .(PCE-DPR-) procedure
updation schedule adherence
1)Specifications
1)New Tools/
2)Product requirements
management

Drawings CFT/
Tooling

HOD-Plant

3)Drawings 1)New Tool Developed

2)Work request PRD/ Tool Replacement
14 4)Bills of material 2)Procedures -PED-DPR-
3)Maintenance Suppliers
5)Maintenance planning
plans
6)Customer specific requirements
HOD-QA, PRD,
Calibration

Calibrated
1)Equipment planning Calibration compliance
PED.

equipment & test Equipment schedules

15 2)Equipment QA trends
reports

1) Material from inward 1)Inspected

HOD-QA,
inspection
Inprocess

1)Process specifications PUR,

2) In process product product
2)Applicable drawings PRD, Rejections tracker
16 3) Customer specific requirements 2)Inspection
3)Control plan STR
4) Engg Documents/Specifications Report
Sl Process Interfaces Measure of
Process Input Output Methods
No Owner with Performance (MOP)
inspection and testing
Finished Product

1) Inspected and tested 1)Process specifications

HOD-QA
1)Finished product
finished product 2)Applicable drawings Number of customer
2)Customer specific PRD
17 2) Final product inspection 3)Control plan complaints
requirements
report 4) Test Procedures
3) Non-conformance reports

1)Number of instruments
Measurement System

1)Instruments in shop conducted MSA as per

floor 1)R&R report schedule
HOD-QA

1)MSA Schedule
analysis

2)Components & products 2)Bias, linearity, stability 2) Number of

2)MSA-procedure(QAD-DPR-) PRD
18 3) Master instruments reports instruments not accepted
3)Work Instructions
4) Customer specific 3)Attribute gage study report (R&R>30%),
requirements conditionally accepted
(R&R>10-30%)
Internal Audit (system)

1) Audit reports & results 1)Audit schedule Vs

1)Audit checklists
2)Corrective and preventive Actual
2)ISO/TS Standard All Sections
1) Annual Plan actions 2) Trends in non-
MR

3)QM-01 in
19 2) Audit schedule 3) Suggestions for conformities
4)(COM-DPR-) internal audit Organization
improvement 3) NCR closing
procedure
4) QMS effectiveness monitoring
Sl Process Interfaces Measure of
Process Input Output Methods
No Owner with Performance (MOP)
1)PFMEA
2)Control plan
3)specifications
1)Annual Plan
Manufacturing
process audit

4)Work Instructions 1) Audit results

HOD-QA
2) conducting audit as per
5)Customer specific 2) Process audit PRD, Process Audit Schedule
schedule
20 requirements nonconformities QA Vs Actual
3)Audit checklists
6)Customer complaints 3) Corrective and preventive
4)(COM-DPR-)
7)Process capability actions
reports
8)Product Audit results
1) Drawings
Product Audit

HOD-ENG

1) Annual plan & schedule

2) Specifications 1)Results of product Audit PRD,
2) Product Audit checklist Product Audit Schedule
3) Customer requirements 2)Audit reports QA
21 3) Approved Auditors list Vs Actual
4) Statutory & Legal 3)Actions plans
4)(COM-DPR-)
requirements
1) Customer delivery
schedules 1)Delivery notes
HOD-PPC &LOG

2) Billing schedules 2)Freight bills

3) Order completion 3)Customer documents 1)Schedule for Trucks Vs
Delivery

1)Inventory management system Customer&

reports 4)Invoices loading
22 PRD
4) Shipping documents 5)Delivery note 2)On time delivery
5) Finished products 6)Packaging materials
6) Customer specific 7)Loading schedules
requirements
Sl Process Interfaces Measure of Performance
Process Input Output Methods
No Owner with (MOP)
conforming
1)Specifications 1)Test instructions

HOD-QA
products 1)Test results 1)Percentage of Rejections
Non-

2)Complaint reports 2)Standards PRD &

2)analysis Reports 2)Percentage of Reworks
23 3)Products 3)Methods CFT
3)8D Reports 3)Defects rate in PPM
4)Customer specific requirement 4)Materials

1)Kaizen
Continual

sections

1)Opportunities for Improvement All 1)Number of CIPs projects

Improve

2)5 S program
All

2)FMEA Improvements 3)Objectives & Targets Company implemented

ment

24
3)Audit results processes 2)Cost savings

1)Discrepancy notes/ Deviation

1)Document changes
Corrective and

notes 1)Weekly Review meetings

Preventive

2)Investigation reports
All HODs
Actions

2)Feedback from process 2)Formation of CFT

3) Filled 8D Report CAPA CFT Problems raised Vs
audits/Product audits 3)Problem solving
25 Formats Team Problems solved
3)Product test results techniques
4)List of recommended
4)Customer complaints 4)(COM-DPR-)
actions implemented
5)Customer specific requirements
1)Market Report /
Research

1) Phone/Direct interaction
MKG-
Head

1)Customer requirements Opportunities

survey/
Market

with customers Customers No. of new customers

26 2)Market data / Competitors 2)New customers
2)Feasibility studies
3)Potential market share
1)Dept. Procedures
RFQ review

1)On time submission of

MKG-Head
&Business
Managers

1)Offer/quotation 2)Checklists
Enquiry/

Customer enquiries/ offer

(Technical & Commercial) 3)Product specifications Costing
27 Specifications 2) New customers,
2)Updated enquiry register 4)Tender guidelines
3) Potential orders
5)cost details
Sl Process Interfaces Measure of
Process Input Output Methods
No Owner with Performance (MOP)
5 Why / 8D problem solving

Head - QA
Handling methods PRD/PE
30 Complaints from Problems raised vs
customer Problem resolution Six Sigma methods mentioned PCE
customers resolved.
complaints in
(QAD-DPR-)
Head- MKG
1)Customer satisfaction Customer satisfaction
Customer
Feed back Reports report questionnaire/feedback form as All the Percentage of customer
31 satisfaction
from key customers 2) Action plan for defined process satisfaction index
measurement
improvements (MKG-DPR-0)

CSR
Head-QAD ,

Contract review, New

Customer Requirements from customer Customer specific
MKG

product approvals, Customer Specific

32 Specific standards - Engg ENGG/QA/ requirements
Customer standards/ requirements report
requirements 1) Agreement during New MKTG compliance status
specifications,
product approvals -
Sl. No Type of External Documents Responsibility for Control

1 National /International Standards HOD- TEC / ENG

2 Product/Material/component catalogues HOD-ENG / HOD-PUR

3 Equipment/Instrument Instruction Manual HOD concerned

4 Statutory/Regulatory Requirements:

a) Factories Act
HOD-HR
b) Maternity Benefit Act

c) Product Related HOD-ENG/TEC

d) Income Tax Act

HOD-Finance
e) Companies Act
 Preparation Approved Review / Distribution /
Level Description Revision / Disposition
Updation

1 Quality Manual MR MD MR MR

Departmental
2 HOD MR HOD HOD
Procedure

2 Common
manuals QMD MR MR MR
procedure Coordinator
3 Work
ManualInstruction HOD MR HOD HOD
Manual
4 Inspection HOD HOD HOD HOD
methods
Forms &
5 HOD MR HOD HOD
Formatted
Registers
Sl. No. Type of Document Document Reference

1 Amendment Record X X X-AMD-X X

2 Check list X X X-CHL-X X

3 Contents X X X-CON-X X

4 Departmental Procedures X X X-DPR-X X

5 Guide Lines X X X-GLS-X X

6 Material specifications X X X-MSP-X X

7 Operating Instructions X X X-OPI-X X

8 Process specifications X X X-PRS-X X

9 Part Specifications X X X-PSP-X X

10 Standard Format Sheet X X X-SFS-X X

11 Standard Formatted Register X X X-SFR-X X

12 Test Methods X X X-TMS-X X

13 Test Specifications X X X-TSP-X X

14 Work Instructions X X X-WIN-X X