Supplier QA Manual - Brakes India

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Nov 2, 2009 ... Auto Ancillary SEZ, Mahindra World City. Natham Sub PO, Chengalpet - 603 002. Rolltec Engineering. (A 100% EOU of Brakes India Limited).
BRAKES INDIA LIMITED

SUPPLIER QUALITY ASSURANCE MANUAL (SQAM)

Revision 2 – November 2009

Supplier Quality Assurance Brakes India Limited Padi, Chennai – 50.

http://www.brakesindia.com/brakesdivision/sqamanual.pdf

Brakes India SQA Manual

Brakes India Limited Corporate Office & Factory Brakes India Limited, Padi, Chennai – 600050 Telephone : (044) 26526000 Fax : (044) 26526960 Website : www.brakesindia.com Other Plant Addresses: Brakes India Limited, Brakes division, Sholingur – 631102. Tamil Nadu. Telephone : (04172) 262276 Fax : (04172) 262210

Brakes India Limited, Cheyyaru - Vandavasi Road, Polambakkam – 631309. Tamil Nadu. Telephone : (044) 27544107 Fax : (044) 27544103

Brakes India Limited, Seals Division 3A, KIADB Industrial Area, Nanjangud – 571302 Karnataka. Telephone : (08221) 228222 / 228787 Fax : (08221) 228333 / 228777

Brakes India Limited 834, Udyog Vihar, Phase V, Gurgaon – 122016. Haryana. Telephone : (0124) 2347810 / 2340571 Fax : (0124) 2342584

Brakes India Limited, 110, GIDC Estate Dhunia VIII, Panchmahal Dist., Halol – 389351. Gujarat. Telephone : (02676) 226144

Brakes India Limited Plot No.3, Gar No.105, Krishna Industrial Park, Waki Budruk, Tal. Khed, Pune – 410 501 Telephone : (02135) 308031 / 308059 Fax : (04172) 262210

Brakes India Limited, B-9, ESIT,Baruabagh Udhamsingh nagar Dt..– 262405 Uttaranchal.

Brakes India Limited Plot No. AA2, 6th Avenue Auto Ancillary SEZ, Mahindra World City Natham Sub PO, Chengalpet - 603 002

Rolltec Engineering (A 100% EOU of Brakes India Limited) No.9, Avadi Main Road, Veeraraghavapuram, Poonamallee, Chennai - 600 077 Telephone : (044) 64541920, 64541921 Fax : (044) 26800522

© Copyright notice. All rights reserved. No part of the manual should be copied (or) published without prior written permission of Brakes India Limited. Initial release Revision 1 Revision 2 Page No: 2

Nov 03 Sep 07 Nov 09 BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Message As a key part of our supply chain, our suppliers play a very significant role to ensure that our products perform consistently well in the field. Today, with the changes in regulations the entire world has become a market place for every one. This has resulted in a highly competitive scenario, wherein to sustain and emerge as a leader, our performance on quality has to be on par with the best supplier in the world. Our customers expect defect free supplies on time every time. We need our suppliers to certify their parts for Direct On Line (DOL). This translates into zero line rejections and warranty rejections. Needless to say this should be achieved at competitive cost. In order to achieve the above target along with you, we formulated a methodology, which has been time tested and successful to compete globally. This was communicated to you through our supplier quality assurance manual. Now, we are releasing this manual in line with our changed requirements. We expect you to strengthen our hands in adopting the methodology followed by us.

S.VIJI Managing Director

Page No: 3

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Acronyms ANOVA BI, BIL CAR CC CP Cp Cpk CRA DOE DOL E, R&D ESQS FFF FIFO FTC ISLR LC LSL MSA MSE NC OEM PPM PFMEA PPAP Pp Ppk PSW PTR QC R RI SOP SC SDI SDS SIR SQA TPM UD

Analysis of Variance Brakes India Ltd & its satellite assembly units. Corrective Action Report Critical Characteristic Control Plan Process performance Index (Long term) Process capability Index (Long term) Cost Recovery Advice Design Of Experiments Direct On Line Engineering Research & Development Evaluation of Supplier Quality System Fit, Form, Function First In First Out First Time Capability Initial Sample Laboratory Report Least Count Lower Specification Limit Measurement System Analysis Manufacturing Systems Engineering Non conformance Original Equipment Manufacturers Parts Per Million Process Failure Mode and Effects Analysis Production Part Approval Process Process Performance index (Short term) Process Capability index (Short term) Part Submission Warrant Production Trial Run Quality Control Range Receiving inspection Start Of Production Significant Characteristic Supplier Development and Integration Supplier Data Sheet Sample Inspection Report Supplier Quality Assurance Total Productive Maintenance Usage Decision (used in SAP)

USL VMI WI X bar

Upper Specification Limit Vendor Managed Inventory Work Instruction Arithmetic average of data

Page No: 4

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual Foreword to Brakes India Ltd SQA Manual, Revision 2 Effective 1st October 2009 the revision 2.0 replaces earlier version of BI, Supplier Quality Assurance Manual. Production part suppliers are to adhere to the BI requirements elaborated in the SQA Manual to achieve & sustain best quality practices at all levels. List of major modifications. 1) Introduction to SQA Activities: Interaction structure modified based on the revised scope. 2)

Pre-PPAP Audit: Guidelines & acceptance criteria modified.

3)

PPAP: Approved supplier list reference given. PPAP categorization details & document requirements specified.

4)

APQP & Safe launch plan: Safe launch plan details were elaborated.

5)

FMEA : This section revised in line with FMEA manual rev. 4

6)

Quality plan & Document retention: Document retention details of various suppliers specified. PPM expectation from suppliers specified. Quality plan format modified to include details about inspection during safe launch period & during customer complaints.

7)

PSW approval: Conditional approval details must be informed to respective units & double sampling to be done till the deviations are corrected.

8)

Skip lot & DOL implementation. Skip lot procedure revised. DOL implementation procedure specified.

9)

Change management: Details about change management / Re-PPAP guidelines added. In case of known violations by suppliers, BI’s action added.

10)

Identification & traceability: DOL tag details specified & tag samples shown.

11)

Quality rating & PPM calculation: Quality rating calculation procedure revised with the modified practice of capturing rework, inspection reports receipt status, process scrap details elimination, etc. Minimum PPM requirement details & action on high PPM suppliers specified.

12)

Control of non conforming products: Tips on Do’s & Don’ts added. CoPQ monitoring requirements added.

13)

Process & Product audit: Audit frequency calculation formulae & methodology specified. Audit questionnaire modified.

14)

Corrective & Preventive action: CAR flow chart modified. In line with the modifications, revised CAR format included.

15)

Cost recovery: This section added. Details regarding cost recovery details specified. Format included.

Apart from this, salient points / caution points are given in boxes for each chapter. Page No: 5

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Index Sl. No

Section #

Click on the Description to go to the respective chapters

Page No.

1) Introduction: This section provides the overview of the manual and list of interacting functions of Brakes India with supplier. 1.1

7

Introduction to SQA activities

2) Supplier selection & Approval process: This section outlines the procedure for new supplier selection and development of new family of parts with existing supplier. 2.1

New supplier selection

9

2.2

Pre PPAP audit & approval process

10

3) New product Development : This section explains in detail the procedure to be followed for new part development & key elements from APQP till completion of safe launch period. 3.1

APQP & Safe launch plan

15

3.2

Production Part Approval Process - Overview

16

3.3

Design, Process, Tooling & Gauge Review

20

3.4

Process Flow Diagram

21

3.5

Process Failure Mode & Effects Analysis

22

3.6

Control Plan

25

3.7

Submission of sample parts

27

3.8

Measurement System Analysis

28

3.9

Process capability monitoring

29

3.10

Special process qualification

32

3.11

Capacity verification

33

3.12

Quality plan & document retention

34

3.13

PSW approval

36

4) Regular production & measurement of performance: This section gives details of controls required on sub suppliers, traceability, etc. It also provides procedure for measurement of supplier performance, supplier audit & DOL procedure. 4.1

Sub supplier quality assurance

37

4.2

Identification & traceability

38

4.3

Control charts

40

4.4

Receiving inspection at BIL

42

4.5

Quality rating & PPM calculation

43

4.6

Control of non conforming parts

44

4.7

Skip lot & DOL implementation

46

4.8

Change management

48

4.9

Process & product audit

50

4.10

Corrective & preventive actions

53

4.11

Tool management

55

4.12

Cost recovery process

56

5) Formats: Gives details of Brakes India specific formats as referred in the manual. ---Page No: 6

List of formats

57 BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Section 1.1 – Introduction to SQA activities Purpose: The purpose of this section is to •

Provide an overview of this manual



Define the document control method followed

• Interaction structure of Brakes India with the Supplier

Scope: This manual applies to all suppliers providing production parts to Brakes India Limited and its subsidiaries.

Explanation:

Overview of the manual 1

All direct material suppliers to B.I. production plants shall be certified for ISO 9001 or TS 16949. ISO 9001 Suppliers shall have a definite time target for TS 16949 certification.

2

Supplier selection and approval method is to ensure supplier with demonstrated abilities of sustaining required quality levels are selected.

3

Production part approval process with specific emphasis on defect prevention and also to ensure consistent delivery capability.

4

The process to be followed for re-qualification of parts that are already under supply.

5

The Change management system to be followed in the event of a change in design / process / location / material etc.,

6

System to be followed to ensure quality sustenance, quality rating and the non-conformance reporting, corrective and preventive action process.

Document control Brakes India Quality Assurance department will provide a soft copy of the manual to the supplier and also intimate to all suppliers, in case of revision.

Supplier shall ensure that the entire operating team is conversant with this manual. Should you have any improvement suggestion about this manual, please send an e-mail to the following address. [email protected]

Page No: 7

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Interaction structure of Brakes India with the supplier The following table describes the interacting functions of Brakes India with the suppliers

Function

Interaction for - Design review (through SQA)

E, R&D

- Concession / Deviation approvals (through unit) - Supplier selection

Supplier Development & Integration

- Business relationships

(SDI)

- Commercials - Sample development (Timeline related) - Issuing & updation of drawings/standard - upto BIR (BI Release) - New Supplier Approval - Production Part Approval - CAR adequacy closure

Supplier Quality Assurance (SQA)

- Quality improvement activities - Process & Product audits - Sample development (Quality related) - Supporting units in implementation of DOL activities. - Delivery schedules - Receiving Inspection - CAR closure based on effectiveness of CAR.

Manufacturing Unit

- Delivery issues. - Payments - Implementation of skip / DOL / VMI - Issuing latest drawings (Released through alteration notes)

Finance / Accounts

- Bill payments (through SDI / unit supply module)

Supplier shall use the documentation / format specified in this manual. However, the supplier may substitute any other forms, provided it contains all the information specified in the Brakes India format. This must be agreed with the supplier quality assurance representative prior to use.

Each & every supplier has been assigned a SQA Engineer as a single window contact. Please feel free to contact him for all your quality related issues and queries.

Page No: 8

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Brakes India SQA Manual

Section 2.1 – New supplier selection Purpose To outline new supplier identification and selection procedure.

Scope: Applies to all production parts.

Procedure

Flow Chart – Supplier Selection Process Supplier Identification

Supplier Data Sheet despatch to supplier

Data receipt ` Evaluation of data sheet

Feasibility Study

Audit as per ESQS (Evaluation of Supplier Quality system)

Commercials

Not OK Judgment OK Gap analysis & closure at supplier end.

For more details on ESQS, please refer the format. Note: A Minimum ESQS score of 70 % is required for supplier selection. Supplier should have minimum valid ISO 9001 certification to be a supplier of BI.

Page No: 9

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Brakes India SQA Manual

Section 2.2 – Pre-PPAP audit & approval process Scope This approval is required for an existing supplier who develops a different part family than existing.

Procedure 1.

BI shall notify the supplier about the exact date of audit in advance. Audit can be planned based upon mutual consent of supplier and BI.

2.

Audit will be based (focused) on audit checklist and following will be covered. a. b. c. d. e.

Part / material receiving Equipments / gauges Machine condition / Machine Layout In-process quality control Inspection

f. Parts shipping area. g. Internal audit by the supplier h. Line rejections & customer complaints i. Corrective & preventive action (problem solving) j. Continuous improvements 3. 4. 5.

Page No: 10

Evaluation criteria are given in the subsequent pages Supplier selection is normally based on a minimum score of 3 out of 5. A minimum score of 3.0 is expected in critical areas such as inprocess, inspection & past track record of supplier. If score is < 3.0, the gaps / observation shall be intimated to supplier by the concerned SQA engineer.

6.

Supplier has to give proper corrective action to close the gaps/observations made during audit with time plan if selected & a re-audit will be done if required.

7.

Selected supplier should follow the procedure for new product development.

8.

The above audit can be waived if the supplier has been already audited / approved for that part family.

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual Pre-PPAP audit sample format is given below. Brakes India Limited

PRE PPAP AUDIT Unit : Unit 12, Product : Wheel. Cyl. assy Location : Chennai

Part Nos.: XXXX Supplier : XX

Present part family supplied : Input rods

Proposed part family : Alu. Plungers

Audit date : 14.07.09

Description

Rating

1. PART / MATERIAL RECEIVING a) Receiving Inspection b) Raw Material Control c) Sub-Supplier Control Average 2. EQUIPMENT / GAUGES a) Calibration b) Availability & maintenance

5 4

Average 3. MACHINE CONDITION / MACHINE LAYOUT a) Maintenance b) Process flow sequence & Shop layout Average 4. IN-PROCESS QUALITY CONTROL a) Work Instructions b) Prevention of Defect (Poke Yoke) c) Non-Conforming Parts Handling d) Monitoring process e) Tool / Fixture Maintenance f) Training for operator g) Process capability / process qualification h) Process flow / Process FMEA / Control plan Average

5. INSPECTION a) Availability & Adherence to Inspection Standards. (In-process & Delivery) b) Sampling Plan availability & adherence. Average 6. PARTS SHIPPING AREA a) Handling of the Parts b) Packing of the Parts Average 7. PAST TRACK RECORD a) PPM / Quality rating – Last 3 months b) Response to BI on complaints. Average Rating : 5 Excellent 0 Not satisfactory

5 4 5 4.66

Overall rating

Comments Incoming parts control from sub-supplier traceability FIFO to be followed. Sub-supplier rejection monitoring required.

Calibration done

4.5

5 4

TPM activities initiated.

4.5

4 5 5 4 5 5 5 5

W1 Available To be implemented for prevention. Route cards to be initiated. Preventive maintenance to be carried out. Process capability carried out PFMEA to be prepared for all parts.

4.75 4

Pre-control charts available. Sampling plan available

4 4.0 3 4 3.5

Fixed quantity packed in boxes Packing instructions available

4 5 4.5 4.34

Minimum overall rating required for approval = 3.0 Minimum 3.0 Reqd. for Sections 4, 5 & 7

Conclusion: Accepted for proposed part family. Page No: 11

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Guidelines for Pre-PPAP scoring RATING

5 Excellent

4 Good

3 Satisfactory

2 Needs improvement

Receiving / incoming controls

RI Quality plan and sampling plan are clear. NC parts handling procedure is established with 100 % adherence.

RI Quality plan and sampling plan are clear. NC parts handling procedure is followed with minor lapses.

RI Quality plan and sampling plan are clear. NC parts handling procedure is not very effective.

Raw material control

100% identification for receipts with 100 % FIFO & traceability adherence.

100% identification for receipts with 100 % FIFO & traceability adherence with minor lapses

Sub supplier control

Sub-suppliers QC activities have been reviewed in detail and every concern have been solved. Periodical audit and development with 100% adherence

Sub-suppliers QC activities have been reviewed & concerns are solved. But no periodical review/Audit plan

100% identification for receipts with 100 % FIFO & traceability adherence not very effective Sub-supplier’s QC activities have been reviewed in detail but concerns are not solved systematically

RI Quality plan available, but not adhered. NC parts handling procedure not available. System is established but FIFO & traceability not followed

Not satisfactory 0 or 1 RI Quality plan, sampling plan & NC handling procedure not satisfactory. No identification system for FIFO & Traceability.

Sub-supplier’s QC activities are not effective

No proper system for sub supplier controls

All necessary gauges / equipments not available

Calibration system not effective

All necessary gauge & equipments are not available. Gauge plan is not available

Gauges & equipments are not available. No gauge planning system

EQUIPMENT & GAUGES Calibration

All necessary gauges / equipment are available Calibration frequency and identification are clear and controlled well with full compliance

Maintenance availability

Preventive maintenance check list for daily, weekly, monthly and annually are clear and complied with.

Page No: 12

All necessary gauges / equipments available Calibration frequency and identification is clear & followed with minor lapses Preventive maintenance check list for weekly and daily basis for all necessary gauges & equipments. Gap in disposal of rejected items & spare availability

All necessary gauges / equipments available Calibration frequency and identification are clear with partial compliance All necessary gauges / equipments available and plan for required gauge & equipments is available

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Guidelines for Pre-PPAP scoring RATING MACHINE Maintenance

5 Excellent

Preventive maintenance check list for daily, weekly, monthly and annually are clear and complied with. Dynamic plan for zero PPM.

IN PROCESS QUALITY CONTROL Process flow / Process flow / PFMEA / PFMEA/control plan are Control plan updated based on any changes with periodical review Eg. Corrective action given to customers on failures. The above should be linked to work instructions and other relevant documents Process Cp greater than 1.67 and capability / trend analysis for qualification improvement Work In addition to instructions requirements for rating 4, signs of updating and standardized job is incorporated

4 Good

3 Satisfactory

2 Needs improvement

Not satisfactory 0 or 1

Maintenance plan based.

Preventive maintenance check list for daily and weekly basis are available but not adhered

Periodical maintenance is not there

Repair only when breakdown

Process flow / PFMEA/control plan are updated based on any changes but no periodical review

Process flow / PFMEA/ control plan are available and updated based on design change etc but it doesn’t link to other documents

Process flow/ PFMEA/ control plan are available but not updated based on design change etc

Process flow / PFMA/ control plan not available

1.33≤ Cp≤ 1.67

1.00≤CP < 1.33

Cp < 1.00

Work instructions are available in the worksite but points are not highlighted Jigs and fixtures (Prevention) are having Poka Yoke but improvement is required Daily check with review

Work instructions are available but inadequate

Process by process check containers identified for defects. NC parts stop in process

W.I are available in the worksite and critical points are highlighted with picture or diagram

Prevention of defects (Poka Yoke)

Poka Yoke works properly throughout the process and are checked for effectiveness periodically.

Poka Yoke works properly. But not checked periodically

Monitoring process

At specified intervals daily and action procedure is clear In addition to requirements for Rating 4, proper action for NC parts and Counter measure plan is established

Route card usage

Non conforming parts handing

Page No: 13

NC parts container identified and segregated in each process and daily rejection review

Not monitored No work instructions are available

Detection Poke – Yoke available but improvement required

No adequate detection

Daily check but no review

Non existence

Final inspection only

No adequate detection. Good and NC parts mixed

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Guidelines for Pre-PPAP scoring RATING

5 Excellent

4 Good

3 Satisfactory

2 Needs improvement

Not satisfactory 0 or 1 No adequate detection. Good and NC parts mixed

Process by process check containers identified for defects. NC parts stop in process Instruction available but not monitored by supervisor

Final inspection only

On job training with instruction

On job training and no instruction

Training for operator

In addition to requirements for rating 4, proper action for NC parts and counter measure plan is established

NC parts container identified and segregated in each process and daily rejection review

Training for operator

Skill level identified & clear instructions and monitoring progress by supervisor All check point for daily, weekly, monthly and annually are clear and controlled. Worn out & rejected tools/Fixtures handling is clear

Instruction available & Skill level identification is not there All equipments check sheet for weekly and daily basis are available. Handling of rejected items not clear

All equipments check sheet for weekly and daily basis are available

All equipment lists are available. No periodical maintenance

Repair when breakdown

Standards are displayed in the work area and updated adequately / periodically & reviewed Gauges / Fixtures are available and sufficient to meet the product quality. They are maintained very well. Frequency is sufficient. NC procedure is clear and countermeasure activity carried out. Zero defect policy evidenced. Adequate and followed as per operation instruction. Trays usage exclusively for specified parts Packing work instructions are available, clear, adequate and properly adhered

Standards are displayed but not updated & reviewed

Standards exist but not maintained well but no review

Standards exist but not displayed & monitored

No standard available

Gauges and fixtures are available & maintained well

Gauges and fixtures are available but not maintained well

Gauges and fixtures are available but not identified properly

Gauges / Fixtures are not available

Sampling plan is followed. But no NC handling procedure & No zero defect plan

Sampling plan is available but frequency is not sufficient

Sampling plan is available with partial compliance

Non existence

Handling procedure & Operation Instruction is adequate & followed

Operation instruction is available but inadequate

Handling procedure is clear followed with partial compliance

Packing procedure & Operation Instruction is adequate & followed

Packing work instructions are available but inadequate

Packing work instructions are available with partial compliance

Handling procedure is not clear. (No clear instruction or caution) Non existence

Tool / Fixture maintenance

INSPECTION Quality check availability and control

Sampling plan

Handling of parts

Packing of parts

Page No: 14

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Brakes India SQA Manual

Section 3.1 APQP & Safe launch plan Purpose To explain key points and submission procedure for the PPAP schedule and initial supply controls.

Scope This applies to domestic suppliers of production part and has to be submitted to BI on demand.

Explanation The goal of APQP – PPAP timing chart is to provide a schedule of the manufacturing and control activities necessary to assure the quality of parts during mass production. Suppliers are required to prepare the timing chart for each part. The schedule should span the time between the issuance of the production drawing and PPAP approval.

Supplier responsibility •

The supplier should create and maintain an APQP – PPAP timing plan before start of the part development plan.



The timing of the various activities of the timing chart at supplier end must meet Brakes India’s requirement.



All the related departments within the supplier must have consensus on the timing chart before submission to BI. In addition, the supplier’s top management is responsible for monitoring this plan to achieve milestones as scheduled.



Brakes India SDI & SQA will review and confirm the supplier’s activity to master schedule. Request for any adjustments will be negotiated between the supplier and B.I.



The supplier must review the timing plan status periodically and any revision must be intimated to BI. The supplier must re-submit the updated timing plan in consultation with Brakes India SDI & SQA.

Safe launch plan •

Safe launch plan will be applied to new products & existing product with major design change. This is to overcome teething problems during the launch & ramping up period. The supplier’s development incharge will be responsible for this. • Safe Launch Plan shall be filed for each part and displayed at the final inspection stage at supplier end. • By default, the exit criteria is 3 months after the part’s SOP. However, the same will be extended by BI’s discretion, based on the problems noticed in the 3 months. • Precautionary activities & preventive activities to be carried out. Typical precautionary activities include increased inspection/ increased frequency/ increased parameters. Typical preventive actions include installing poka-yokes, deploying certified operators, frequent audits in shop floor, reduced cycle time for problem solving. • Identify the part with the necessary pilot batch identification tag (discussed in coming pages) & ensure adequate special care is taken to eliminate mixup, damages, rust. A sample safe launch plan is shown in the annexure.

Page No: 15

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Section 3.2 – Production Part Approval Process - Overview The Production Part Approval Process (PPAP) defines generic requirements for production part approval. The purpose of PPAP is to determine if all customer engineering design records and specification requirements are properly understood by the supplier and the process has the potential to produce parts consistently to meet these requirements during an actual production run at the quoted production rate.

Scope: PPAP shall apply to all suppliers during the period from release of mass production drawings to start of production. PPAP is optional for lubricants, carton protection sleeves, stickers, bars, tubes, assembly fluids, sheets, packing containers, ingots & indirect materials.

Procedure

Flow chart – Production Part Approval Process Decision to buy

New supplier

Existing supplier

ESQS audit

Same part family

New part family

Pre-PPAP audit

Not Approved

Approved Capable

Not capable

Design / Feasibility review / Timing plan - Discussion Select another supplier Sample submission / inspection OK

Not OK

Process correction

Production trial run by supplier / BI-SQA based on part categorization Quality plan documentation & agreement

PSW Sign off

Straight approval

Conditional approval

Inform unit with details

Review

Action plan

Upload in database & inform unit

Page No: 16

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual 1.

For a new project a routing sheet will be prepared which details out whether the parts are to be produced in house or to be sourced out. Once this is done, SDI will identify the source for the same. ESQS audit approval is required for any new supplier. Details are given in new supplier selection section. In case of new part family with existing source, supplier has to score 3 min in the pre-PPAP audit sheet. Supplier will be called for design review, feasibility review & process review. Supplier shall have a timing plan and have periodic reviews with Brakes India during development period. Samples, inspection report & process flow chart to be submitted to SDI who in turn will forward the same to manufacturing unit for inspection. The procedure is further detailed out in sample submission section. Manufacturing unit will clear the samples after obtaining comments from E,R&D and approve the initial samples inspection report. PPAPs are categorized based on part criticality / supplier’s capability, etc. Documentation requirements are specified in the guidelines in the following pages. List of PPAP documents to be submitted, the format to be used and methodology to be followed are explained in the subsequent sections. Supplier to ensure compliance in the production line as per the documents submitted. Upon confirmation, SQA representative will visit the supplier and will witness a production run for 300 nos. or one shift quantity (whichever is minimum) as per the documents and fill in compliance audit report. Yield of OK parts should be minimum 90 % for approval. If the production run is satisfactory and there are no concerns, the PSW will be approved by SQA. Otherwise, a re-run will be required or the PSW will be conditionally approved. In the event of conditional approval the supplier has to submit a firm action plan. Further details are given in PSW approval section. Supplier has to inform SQA upon implementation of action plan and then it will be verified by SQA and the conditional status will be removed provided the implementations are satisfactory. PPAP level is based on BI’s discretion.

2. 3. 4. 5. 6. 7. 8. 9. 10.

11.

12. 13.

Page No: 17



Supplier is responsible for the quality of their parts supplied to BI, irrespective of any operating conditons.



For both sample submission & for regular mass production, supplier must buy rawmaterial or do special processes in BI approved sources only as specified in TD 1-30-07. Violations if any will be looked into seriously by BI including cost debits.

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Guidelines for categorization of parts Commodity Group 1 Machining ,Casting, Forging, Sintering

Commodity Group 2

Commodity Group 3

Pressed parts, Special process,

Friction, Spring, Plastic, Rubber

Proprietary assembly

parts

Critical Parts – A Category Heat treated parts

Chamber brackets

All coil springs

Hard chrome & trivalent plated

Tolerance 0.1mm or less

Welded reservoirs

parts

Anti rattle clips

Pin boots

Surface finish 0.8 Ra or less

Pad backing plate

Piston boots

Tolerance 50 Microns or less

Reaction disc NRV, Linings Major parts – B Category

Part from new sources

Part from new sources

Part from new sources

Special Fasteners

Pad wear warning indicators

Spacer for ‘S’ Cam

Castings

Push rods

Non welded reservoirs

Lever pawls

Adaptors Filler caps Filter mesh

Others – C Category Rivets, Standard fasteners

Proprietary parts from TRW

Protective plugs

Proprietary parts from TRW

Customer specified sources

Spacers for calipers

Customer specified sources

TRW supplier parts.

Bleed screw caps

TRW suppliers parts

Gaskets Proprietary parts from TRW Customer specified sources TRW suppliers parts

Page No: 18

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Brakes India SQA Manual

Document requirements of PPAP A Category parts: (PTR by BI compulsory) All 18 requirements as in AIAG manual PPAP rev. 4 which includes SIR/ISLR and Brakes India specific requirements as given below. 1) Design review minutes (or) supplier’s letter that he will meet all drawing + Cp, Cpk requirements identified in drawing as well as identified during PPAP. 2) Quality plan. 3) Capacity verification based on run at rate, shared capacity & machine utilization. 4) PPAP checklist (To be filled by SQA Engineer) 5) Packaging specification sheet 6) Compliance audit (Conducted at supplier end by SQA Engineer) 7) Conditional approval sheet (If required) 8) Fit, Form & Function check sheet

B Category parts: (PTR by BI optional) All 18 requirements as in AIAG manual PPAP rev. 4 which includes SIR/ISLR and Brakes India specific requirement as given below. 1) Design review minutes (or) supplier’s letter that he will meet all drawing + Cp, Cpk requirements identified in drawing as well as identified during PPAP. 2) Quality plan. 3) Capacity verification by supplier. 4) PPAP checklist (To be filled by SQA Engineer) 5) Packaging specification sheet 6) Compliance audit (Conducted by supplier) 7) Conditional approval sheet (If required) 8) Fit, Form & Function check sheet

C Category parts: (PTR by BI optional) C Category (Import) TRW / MAN / Hitachi / Meritor & other customer approved PSW (Level 1) Accepted SIR / ISLR or Supplier’s insp. reports PPAP Check list – C category

C Category – Domestic PSW – level 2 ticked (Supplier to retain all other documents at his end – Auditable by BI) PPAP Check list - C category Quality plan for particular part Control plan (Generic) Approved SIR and ISLR by B.I Capacity verification (mail confirmation is also acceptable) Fit, Form & Function matrix (If applicable)

For all the above categories, if OEM customer asks for further documents, the same needs to be submitted on case to case basis.

Page No: 19

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Section 3.3 – Design, Process, Tooling and Gauges review Purpose To explain procedure for the design, process, checking fixture, tooling and gauges review with supplier and agreement with B.I. SQA representative.

Scope This applies to domestic suppliers of production part.

Explanation The goal of these reviews by BI SQA representatives with supplier is to 1.

Appraise the supplier of the functional requirements of the components.

2.

Discuss parameter by parameter about achieving the dimensional requirements, process capability requirements & metallurgical requirements packing requirement in production.

3.

Identify and agree the significant & critical characteristics based on drawing / based on functional requirements. Design review format is given in annexure.

Design review - Once the drawing is received, supplier has to study the drawing in detail. - In case the drawing refers TS / TD / other standards, please get & understand the related requirements. - Wherever SC/CC characteristics are mentioned, ensure that there is no issue in meeting process capability. - In case the drawing requirements / process capability requirement meeting is doubtful, discuss this in design review. - Understand all the Fit, Form & Function characteristics during design review. - A properly conducted design review will solve design related issues & help deliver “First time right”

Page No: 20

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Section 3.4 –Process Flow diagram Purpose To explain process flow diagram and submission procedure.

Scope This applies to all parts and components

Explanation The process flow chart is a schematic representation of current or proposed process flow. It can be used to analyze the sources of variation of machines, materials, methods and manpower from the beginning to the end of a manufacturing or assembly process. It should be used to emphasize the impact of sources of variation on the process. The flow chart helps to analyze the total process rather than individual steps in the process. The flow chart assists the Product Quality Planning team to focus on the process when conducting the PFMEA and designing the control plan.

Supplier responsibility 1. Raw material, Sub supplier name and Location specific to supplier own manufacturing unit should be clearly addressed in process flow. 2. Any changes in sub supplier activity to be informed to B.I. immediately and process flow should be updated. All critical and significant stages to be identified. 3. All critical and significant stages to be identified.

Sample Process Flow Diagram

Page No: 21

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Section 3.5 – Process Failure Mode & Effects Analysis (PFMEA) Purpose To explain PFMEA creation and submission procedure

Explanation A PFMEA is an analytical technique used to identify potential problem areas associated with all stages of manufacturing i.e. right from receipt to dispatch. Efforts shall be taken to improve the process to achieve defect prevention rather than defect detection.

Procedure 1.

The starting point for a PFMEA is process flow diagram and data on things gone wrong.

2.

A Cross-Functional Team should study each step of the process for process failure modes, effects of failure and potential causes. Existing conditions should then be reviewed and rates for the likelihood of severity (S), occurrence (O) and detection (D).

3.

The product of these ratings is the risk priority number (RPN) for each possible cause of failure. The RPN establishes priorities for investigating counter measures for each potential cause of failure. As countermeasures are implemented, the results are recorded and RPN is recalculated.

4.

Do not use words like “Operator error” as a potential failure. The failure is rooted to the process or system.

5.

All critical and significant characteristics must be addressed in PFMEA.

6.

The PFMEA is a living document that should be utilized / updated for the life of the part.

7.

The table below gives the rating number to be given for each failure mode.

8.

For further reference supplier to possess AIAG’s FMEA manual. 4th edition, release June 2008.

The outcome of a PFMEA will be the control plan; Poka Yoke and work instructions. •

PFMEA is a live document and has to be updated by the supplier during design change / process change, customer complaint elimination, reduction of internal rejection, etc.



Wherever the severity rating of the defect exceeds 8, supplier shall plan and implement poka-yoke in process.



RPN should not exceed 100. Wherever RPN is more than 100, suitable actions required to reduce RPN. When severity rank is 9 or 10 its corresponding occurrence and detection should not go beyond 2 & 4 respectively.



• In case the above is not adhered, a firm action plan is mandatory.

Page No: 22

BI - SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Severity rankings Effect Failure to Meet Safety and/or Regulatory Requirements

Loss or Degradation of Primary Function

Loss or Degradation of Secondary Function

Annoyance

No effect

Page No: 23

Criteria: Severity of Effect on Product (Customer Effect)

Rank

Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning. Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning. Loss of primary function (vehicle inoperable, does not affect safe vehicle operation). Degradation of primary function (vehicle operable, but at reduced level of performance)

10

Loss of secondary function (vehicle operable, but comfort / convenience functions inoperable) Degradation of secondary function (vehicle operable, but comfort / convenience functions at reduced level of performance) Appearance or Audible Noise, vehicle operable, item does not conform and noticed by most customers (> 75%). Appearance or Audible Noise, vehicle operable, item does not conform and noticed by many customers (50%). Appearance or Audible Noise, vehicle operable, item does not conform and noticed by discriminating customers ( 100 per thousand > 1 in 10 50 per thousand 1 in 20 20 per thousand 1 in 50 10 per thousand 1 in 100 2 per thousand 1 in 500 .5 per thousand 1 in 2,000 .1 per thousand 1 in 10,000 .01 per thousand 1 in 100,000 1.33

- For SC/CC & major characteristics if the process capability is not met, it is mandatory to do 100% inspection before dispatch. - In the case of one sided specification, Only Ppk / Cpk need to be computed using the formula indicated above and not Pp / Cp. Page No. 30

BI – SQAM Rev: 2 – Nov 09

Brakes India SQA Manual

Ppk value and level of PPM Sl. No 1 2 3 4 5 6 7 8 9 10

Ppk < 0.55 > 0.55 > 0.78 > 0.86 > 0.94 > 1.00 > 1.10 > 1.20 > 1.30 > 1.67

PPM > 100000 50000 20000 10000 5000 2000 1000 500 100 < 10


= 1.67 Cpk > = 1.33

Cp = CpK = n =

HISTOGRAM

2.27 1.63 42

200

30

180 25

160 140

20

120 100

15

80 10

60 40

5

20

No. of Class :

Observation : -

4.78

4.78

4.77

4.77

4.77

4.76

4.76

4.76

4.75

4.75

0 2.37

0

4

1-5

6 - 10

11 - 15

16 - 20

21 - 25

26 - 30

31 - 35

36 - 40

41 - 45

4.760

4.763

4.755

4.759

4.761

4.761

4.758

4.760

4.757

4.756

4.760

4.757

4.758

4.756

4.757

4.758

4.758

4.758

4.760

4.758

4.758

4.761

4.765

4.756

4.759

4.760

4.761

4.760

4.760

4.762

4.761

4.762

4.758

4.757

4.761

4.758

4.757

4.760

4.763

4.760

4.762

4.758

Observed beyond Specification :

46 -50

Target Nominal : 0.00%

Estimated beyond Specification : 0.00% ACTION PLAN FOR IMPROVEMENT(IF NOT CAPABLE)

4.755

Average (X): Std.Dev. (O): (sigma) Prepared by :

4.759 0.0022

Sign & Date Approved by :

Sign & Date

1

CORRECTIVE ACTION REPORT (CAR) BRAKES INDIA LTD Supplier / Vendor code :

Part name:

C.A.R.No. / Unit

Part number:

CAR raised date :

Drg Issue no:

Reported by:

Customer:

Authorised by :

Product model :

CAR sent to supplier on date:

Supplier Plant/Location :

CONCERN RANK

A

B

C

Supplier DC / Invoice no:

DC date:

Lot reference:-

Qty Received :-

BI GR no:-

GR Date:-

Complaint Identified at Receipt stage

Assy stage

Product Audit

Assy testing

Others specify:

Fitment

Functional

Packing / Labelling

Dimensional

Aesthetics / Visual

Material

Skip Part

PPAP approved

Non -skip part

Yes

Customer End Complaint details

Others specify Complaint history

Repeated

No

Non conformance description PROBLEM

Sl.No.

Defect Photo/Sketch (Attach separate sheets if necessary)

Non conforming quantity: Specify other details wherever necessary Defective sample retained with unit

Sample given to supplier

Quantity available at Brakes India for disposition:

Sample / photo shown to supplier

CRA ref No. (if any)

Unit Recommendation Segregate

Rework

Concession by BI

Reject to supplier

SUPPLIER TO SEND CORRECTIVE ACTION PROPOSAL WITHIN 10 DAYS FROM RECEIPT OF CAR Guidelines for ranking of CAR Customer Complaint/Repeat CAR in same part number after closure of original CAR by unit /OE fitment dimensions Line stoppage due to quality issue/Dimensional issue in significant & critical characteristics Others(Dimensional deviation not affecting fit & function/Aesthetics/Handling damage/Mix up/Rust,etc) Format : BI / CAR

Rev- 03 - May 09

A B C

Page : 1 OF 3

UNIT

New

CONTAINMENT ACTION NG Parts checked at

Date

OK

Reject

Rework

Identification mark on OK part

Remarks

Brakes India In Transit Supplier Inhouse Sub - Supplier

ANALYSIS TOOLS C&E DIAGRAM (4M)

5 WHY ANALYSIS

SCATTER DIAGRAM

CHECKSHEET

STRATIFICATION

HISTOGRAM

PARETO ANALYSIS

CONTROL CHART

Guidelines : Atleast 2 tools to be used, 3 or more tools preferable. Narrate briefly the QC tool used.(Provide attachments wherever necessary)

CAUSE & EFFECT DIAGRAM MAN

MATERIAL

SUPPLIER

METHOD

MACHINE

WHY - WHY ANALYSIS Why it occurred

Why it was not detected

1

1

2

2

3

3

4

4

5

5

DEFECT CLASSIFICATION Process

Tooling

Gauging

Packing / Labelling

System

Machine

Handling

Operator

Maintenance

Training

Rework

Format : BI / CAR

Rev- 03 - May 09

Page : 2 OF 3

CORRECTIVE ACTION IDENTIFIED ROOT CAUSE

CORRECTIVE ACTION

RESP

TGT DATE

OCCURRENCE

DETECTION

SUPPLIER

HORIZONTAL DEPLOYMENT ON SIMILAR PARTS / PROCESSES: YES

NO

(Furnish details if YES)

STANDARDISATION OF CONTROL DOCUMENTS PFC

CONTROL PLAN

PM CHECKLIST

DRAWINGS

QUALITY PLAN

GAUGE DRAWING

FIXTURE DRAWING

PFMEA UPDATED

PACKING INSTRUCTION

TOOL DRAWING SOP

Note : Attach supporting details / documents where ever necessary

CORRECTIVE ACTIONS WITH EFFECT FROM: Cut off DC / Invoice no & Date : Supplier Representative Name:

Sign:

Date:

PHYSICAL VERIFICATION OF CORRECTIVE ACTION IMPLEMENTATION (IF REQUIRED )

YES

NO Date:

Approved by:

Date :

SQA

SQA Engineer: CORRECTIVE ACTION ADEQUACY OYES

NO

CORRECTIVE ACTION CLOSURE (BY ORIGINATING UNIT) : Date:

UNIT

Signature:

Note: Unit to monitor the effectiveness of corrective actions (for 3 lots or 1 month, based on unit's discretion), sign and forward this copy to SQA for updating the database.(SQA Repository) Format : BI / CAR

Rev- 03 - May 09

Page : 3 OF 3

Fit, Form & Function Matrix To: Mr. Unit no: The below mentioned FFF activities were implemented with effect from supplies dated: _______________. Please monitor the lots after this & arrange for skip introduction as per usual skip inspection procedure (if not already implemented)

Supplier Name : Part No

Sl No.

:

Issue no

Fit, form, function Characteristics ( including SC/CC ) Characteristics

Specification

Category of FFF

Customer :

Date :

Part Name :

PPAP Completed: Yes / No

Present process controls available Machine name / type

Fail Safe

Process capability

Checking method used in manufacturing 100% line inspection

No. of cavities

Past complaints (Last 1 year) OEM complaint

BI - Line Rejections

Incoming Rejections

Inhouse rejections@ sup end.

Remarks / action plan for improvement

Resp.

Target

DOL stage inspection details

Dock audit & inspection Report.

1 2 3 4 5 6 7 8 9 10 11 12

Note : 100% inspection required if there is no fail safe for OEM customer fitment characteristics. Recommended process capability for all FFF characteristics is Cpk > 1.67. All FFF characteristics should be covered in Final inspection report. For all OEM customer fitments 100 % insp. is required either in line or final insp. or DOL station when Poka-yoke is not there. Sampling plan a) n=as per BI sampling plan, c=0 b) n=5, c=0 If there is any rejection in sampling inspection, 100 % inspection should be done for that characteristic.

Window Engineer name :

Unit Representative name:

Supplier representative name :

Sign :

Sign

Sign :

Fit : The ability of item item to physically interface or interconnect with or become an integral part of another item. Form : The shape, size, dimensions, mass, weight, and other visual parameters which uniquely characterize an item. For software, form denotes the language and media. Function : The action or actions which an item is designed to perform. Format : BI / FFF Matrix

Rev 2

Brakes India Ltd., Chennai

Process And Product Audit Report Reason for the Audit

Supplier / Sub - supplier / Satellite unit audited

Overall Audit Priority Rating

Date Routine / High CAR / Change Mangement Suppliers left Critical Auditor: ( Location / our in prev. Supplier of the Subsupplier) plans Month

Application

Part No. / Name

Audit No.:

Audit

1

Process Owners

Previous audit Machining

Inhouse processes audited

Forging

Pressing

Moulding

Heat treatment

Welding

Protective finishing Lining / Bonding

Complete Process Sequence

Sub-supplier process audited (if any)

Machining

Pressing

Moulding

Protective finishing

Forging

Heat treatment

Welding

Lining / Bonding

Result %

0 0

Casting

Springs

Assembly, Subassembly / Testing

Bar rolling Packaging

Casting

Springs

Assembly, Subassembly / Testing

Bar rolling Packaging

Others :

Process Audit Achieved Score Reference Score

Process Product Process Product

Degree of Conformity

Others ( please mention):

Complete Process Sequence

Main Elements (Process)

Score (%)

Main Elements (Product)

Product Audit Achieved Reference Score Score

Result %

I Process Quality Planning

0

30

0

Dim adherence

0

10

0

II Personnel Qualification

0

20

0

Capability

0

10

0

III Receiving Stage and storing

0

20

0

In house rejection

0

10

0

IV Production Stage

0

70

0

Endurance

-

-

-

0

30

0

Other attributes

-

-

-

0

30

0

0

200

0

Overall Score (I+II+III+IV+V)

0

30

0

Packaging, Storage, Handling, V Transporting, EMS & OHSAS

requirements Failure Analysis, Corrective VI Actions and Continual

Improvements. Over all Score (I+II+III+IV+V+VI)

Grading Overall Degree of Conformity %

Grading of the Process

Grading

90% to 100%

Full Compliance

80% to 89%

Predominant Compliance

60% to 79%

Partial Compliance

B

No compliance

C

Less than 60%

Auditor/s Signature & Date Copies for Circulation to :

FM/SM/SA/01-Oct07

A

Reviewed by Signature & Date SDI

Remarks

Units

AB

Approved by Signature & Date

If any of the above elements in Process audit is less than 60%, Grading is downgraded by one step. i.e., A to AB or AB to B or B to C

Auditee / Process Owner Signature & Date

Brakes India Ltd., Chennai

Supplier Process Audit

General Information Name : Location: Other manufacturing sites: (if any) Established in: Total Employee strength : (Permanent employees) Regular Working norms : (shifts x hrs) Annual Turn over Tie-ups (if any) Core Manufacturing Competance: Manufacturing , testing and validation facilities available Quality Certifications ISO 9001:2000

Certificate

ISO TS 16949

ISO 14001

Certifying Body Obtained in (Year) / target dt. (if planned)

Date of Cert : Date of Expiry :

Date of Cert : Date of Expiry :

Date of Cert : Date of Expiry :

Quality issues :Last 6 months PPM

At BI :

Last One year CAR's raised Total No.of Parts supplied to BIL No.of New parts added PPAP Status Business relationship with Brakes India Ltd. Business with BIL: (Since) Major parts supplied to BIL Business share of BIL: Future Plans

FM/SM/SA/01-Oct07

At Supplier end :

Others

Audit Score Sheet Process Audit

1 Process Quality Planning 1 Process Flow Chart

Rating 0, 4, 6, 8, 10 0

2 PFMEA

0

3 Control plan

0

Personal Qualification

Rating 0, 4, 6, 8, 10

1 Responsibiilty and Authority

0

2

2

Qualification, training and suitability of personnel

3 Receiving Inspection & Stores 1 Receiving inspection and Subsupplier control

Achieved Reference score Score

0

Achieved Reference Score score

0

Rating 0, 4, 6, 8, 10

% Score

0

Achieved Reference score Score

% Score

0 20

0

0 Rating 0, 4, 6, 8, 10

4

Production Stage

1

Appropriateness of work and inspection stations to the needs.

0

2

Approval for production starts and recording of adjustment details / deviations.

0

3 Quality Monitoring.

0

4 Adhrence and adequacy of process parameters

0

5 Machine management

0

6 Tool management

0

7 Instruments and Gauges management

0

FM/SM/SA/01-Oct07

20

0

0

0 2 Stores

30

% Score

Achieved Reference Score score

0

70

% Score

0

Audit Score Sheet Process Audit Rating 5

Packaging, Storage, Handling , Transporting EMS and OHSAS 18001 requirements

0, 4, 6, 8, 10

In-house material handling. Tracebility and 1 security against mix-up / exchanges by mistakes of parts and material flow. 2

Achieved Reference Score score

% Score

0

Tuning of transport materials & packing to the special properties of the product.

0

3 EMS & OHSAS 18001 Requirements

0

30

0

0 Rating 0, 4, 6, 8, 10

6

Failure Analysis, Corrections, Continual improvements

1

Availability of Target parameters for product and process & monitoring of compliance.

0

2

Continual improvements of product and process.

0

3

Carrying out corrective actions on time and check for effectiveness in the process.

0

Achieved Reference Score score

0

30

% Score

0

Product Audit 7 Product Audit

Rating 0, 4, 6, 8, 10

Achieved Reference Score score

% Score

1 Dimensional Adherence

0

0

10

0

2 Capability

0

0

10

0

3 Internal rejections

0

0

10

0

4 Endurance / Other Attributes

-

-

-

-

5 Other Attributes

-

-

-

-

Evaluation of Compliance with individual requirements: Full compliance with the requirements

10 Points

Predominant compliance with the requirements with minor nonconformity

8 Points

Partial compliance with the requirements with more severe nonconformity

6 Points 4 Points 0 Point

Unsatisfactory compliance with the requirements with major nonconformity No compliance with the requirements

FM/SM/SA/01-Oct07

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

Main Check Sub Element Element List No.

Part No. 0

Look for (Check list) PFC No.:

1) Process Quality Planning

1) Process Flow

1.1.01

Adequacy of sequences from receiving up to shipping.

1.1.02

Are the latest copies of Drawings / Specifications available with supplier?

1.1.03

Any significant change in the process flow in the past 12 months due to process improvement or customer concern ? If yes, look for process validation .

1.1.04

Availability of Raw materials supplier details in PFC

1.1.05

Identification of CC & SC stages

1.1.06

Availability of sub-supplier details in PFC PFMEA No.:

2) Process FMEA

Supplier Process Audit

1.2.01

Adequacy of sequences in line with process flow.

1.2.02

Considerations & identifications on CC& SC

1.2.03

Any method exists for updating PFMEA on ongoing basis

1.2.04

Reviews based on RPN, severity, excess scrap / rework, customer concerns, etc.

1.2.05

Are actions based on PFMEA reviews completed on targets?

1.2.06

Are Poka Yoke’s included in PFMEA?

Highlights of positive Rating compliance / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsi bility

Issue No.:

#DIV/0!

Issue No.:

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Target

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

Main Check Sub Element Element List No.

Part No. 0

Look for (Check list)

1) Process Quality Planning

CP No.:

3) Control Plan

Supplier Process Audit

1.3.01

Is CP in line with Process Flow & FMEA?

1.3.02

Are all S.C’s & C.C’s identified in CP?

1.3.03

Are PFMEA changes & concerns identified in CP?

1.3.04

Is CP adequate covering all tests / checked fixtures / gauges / frequencies / responsibilities / historic concern?

1.3.05

Does CP address all dimensions as per drawings?

1.3.06

Does CP address process characteristics?

1.3.07

Does CP address corrective actions in case of non conformities (Reaction plan)?

1.3.08

Does CP cover agreed standards / practices not specifically addressed in the drawing (like burr free, flash free, surface finish, acceptance limits, etc) ?

1.3.09

Does CP cover layout inspection and functional testing?

1.3.10

Does CP cover packaging and despatch standards?

1.3.11

Does CP address each stage’s process validation & frequency?

1.3.12

Are Poka-Yoke devices uniquely identified in CPand their shift wise qualification / validation?

1.3.13

Does PFC , PFMEA , CP address actions based on findings of the previous audit?

Highlights of positive Rating compliance / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsi bility

Issue No.:

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Target

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

Main Element

Sub Element

1) Organization structure

2) Personnel & Qualification

2) Roles , Responsibility & authority (Competency of employees, required to perform their role)

3) Qualification, training & suitability of personnel

Check List No.

Supplier Process Audit

Part No. 0

Look for (Check list)

2.1.01

Do they have a clearly defined organization structure?

2.1.02

Is there a Customer Contact Persons identified for Quality Issues

2.2.01

For management of modifications & NCs

2.2.02

For operating & work instructions ( Design / Engg / QC )

2.2.03

Adequate resource for Inspection activity covering all the shifts (QC / QA / Manufacturing)

2.2.04

For process approval and release ( QC / QA / Manufacturing )

2.2.05

For set-up approval (First-off & Last-off) ( QC / QA )

2.2.06

For interpretation of control charts ( Prod / QC / QA / Manufacturing )

2.2.07

To stop production on NCs ( QC / QA )

2.2.08

For rework approval ( QC / QA )

2.2.09

For environmental safety ( Personnel / HR )

2.3.01

Qualification / Skill matrix availability

2.3.02

Training calendar and adherence

2.3.03

Product knowledge

2.3.04

Knowledge of consequences to customer in case of N.C products / processes

2.3.05

Health and safety at work awareness.(OHSAS)

2.3.06

Availability of skilled personal ( At receiving inspection, Line inspectors, Final inspection, Production, Maintenance, Tool design/ maintenance, QA, Calibration, etc)

2.3.07

House keeping training.

2.3.08

Training on problem solving methods pertaining to their jobs.

2.3.09

Skills on process capability studies & M/c capability studies

2.3.10

Qualification records (Welding certificate, driving license for industrial trucks, eye sight test for viewers, etc.)

2.3.11

Carrying out & ordering the installation & calibration of inspection, measuring & test equipments

2.3.12

Knowledge on MSA

2.3.13

Training on handling of parts, equipments at each stage.

2.3.14

Carrying out continual improvements - Waste elimination, cost reduction, cycle time reduction, setup times

2.3.15

Knowledge on error proofing / Poka-Yoke

Highlights of positive Rating complaince / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating Observations / Points for improvement along with objective Action evidence Plan 0,4,6,8,10

Responsibi lity

Target

#DIV/0!

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Brakes India Ltd., Chennai

Audit rating check sheet

Supplier : 0

3) Purchase, Receiving stage, storage and sub-supplier management

Main Check Sub Element Element List No.

1) Receiving stage

2) Storing

Supplier Process Audit

Part No. 0

Look for (Check list)

3.1.01

Are incoming packages appropriate (as per purchase order)

3.1.02

Availability of product drawing, Inspection plan, material history cards etc.

3.1.03

Sampling plan – Is zero defect policy evidenced?

3.1.04

Availability of suitable TD/TS

3.1.05

Is RM procured from approved source as per Specefication ( TD 1-30-07 ) & for Rubber items ( Check validation done by Supplier )

3.1.06

Are RM test parameters verified at defined interval as per CP / QP?

3.1.07

Are calibrated / adequate inspection/test facilities available?

3.1.08

Is self inspection reports received from suppliers

3.1.09

Supplier rating availability

3.1.10

Supplier audit schedule and adherence

3.1.11

Source audit approval record

3.1.12

CAR on vendor rejections & adequacy of corrective actions and how the system is effective?

3.2.01

Tidiness

3.2.02

Clear identification & separate locations for materials looking alike.

3.2.03

Roofed area / Area available to total R/M handled and any Rust preventive method adopted if any ? and Raw materia stored properly to avoid deterioration?

3.2.04

Availability of identification cards / colour codings (Status card - Accepted / Rejected / Under inspection, RM Heat code etc.)

3.2.05

Any chances of mix-up?

3.2.06

Is quarantine area clearly isolated and adequate?

3.2.07

Shelf life items storage ( Have the Shelf Life Items been identified and validation takes place periodically? )

3.2.08

FIFO controls and stack records

3.2.09

Lighting / Safety / Easy access

3.2.10

Traceability

Highlights of positive complaince / Areas needing improvement

Rating 0,4,6,8,10

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsi bility

#DIV/0!

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Target

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

4) Production Stage

Main Check Sub Element Element List No.

1) Appropriaten ess of work & inspection station to the needs

Supplier Process Audit

Part No. 0

Look for (Check list)

4.1.01

Work instructions adequacy & compliance

4.1.02

Stage drawings adequacy & compliance

4.1.03

Process parameter display at relevant stages (E.g. Pr, Temp, time, speed, feed, Location of resting & butting, etc) & Are SOP's displayed near the Machine/cell

4.1.04

Inspection instructions adequacy & compliance (Does the Inspection Plan / Control Plan bears Customer designated Critical & Significant Characteristics ?)

4.1.05

Rework / Scrap instructions / procedures ( Do they have a system of handling rework / scrapped parts ? )

4.1.06

Quarantined & ear-marked WIP area

4.1.07

Availability of quarantined final inspection area

4.1.08

Tidiness , cleanliness ,ergonomics, lighting etc

4.1.09

Clear identification & separate locations for materials looking alike.

4.1.10

Availability of inspection table, work table etc

4.1.11

Availability of in & out bins

4.1.12

Marked containers for reject/ rework/ adj parts ( Eg. Red bin analysis for rejected parts)

4.1.13

Defined rework station

4.1.14

Health and safety at work (OHSAS)

Highlights of positive Rating Avg. Rating complaince/ Areas needing 0,4,6,8,10 Rating 0,4,6,8,10 improvement

Observations / Points for improvement along with objective evidence

Action Responsibi Target Plan lity

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

Main Check Sub Element Element List No.

4) Production Stage

2) Approval for production starts and recording of adjustment details and deviations

3) Quality monitoring

Part No. 0

Look for (Check list)

4.2.01

Set up & last off approvals (With samples)

4.2.02

1st principle method of 1st OFF approval

4.2.03

Stage inspection adherence as per schedule

4.2.04

Control and regulation of important parameters, process qualification (DOE etc) & Is application of Statistical Tools evident in Shop Floor ? (Process Monitoring Chart / X bar - R Chart, Run Charts etc.)

4.2.05

Changed Production parameters

4.2.06

Availability of instruments, gauges and adequacy (Like profile projector, surf tester, height gauge,hardness tester crack detection etc)

4.2.07

Machine and process capability evidences for important characteristics and process parameters

4.2.08

Recording of rejections / rework

4.3.01

Is there a Master list of Gauges / Instruments / Jigs & Fixtures ?

4.3.02

Triggering mechanism for calibration of instruments / gauges / jigs& fixtures?

4.3.03

MSA/ R&R

4.3.04

Relaibiltity, function and corrosion resistance tests (if applicable).

4.3.05

Layout inspection schedule and adherence

4.3.06

Adherence to submission of reports as per Quality Plan

4.3.07

Availability of SQA Manual, awareness and deployment in shopfloor

4) Adequacy and Adherence to process parameters 5) Machine management 6) Tool Management 7) Instruments / gauges / fixture management

Supplier Process Audit

Highlights of positive Rating Avg. Rating complaince/ Areas needing 0,4,6,8,10 Rating 0,4,6,8,10 improvement

Observations / Points for improvement along with objective evidence

Action Responsibi Target Plan lity

#DIV/0!

#DIV/0!

Refer Annexure 1 Refer Annexure 2 Refer Annexure 2 Refer Annexure 2

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Audit rating check sheet

Brakes India Ltd., Chennai Supplier : 0

5) Packing, storage , Handling transporting and ISO 14001 Requirements

Main Element

Sub Element

1) Inhouse material handling & storage / Traceability and severity against mix up/ exchanges by mistake for parts and material flow

2) Tuning of transport materials and Packing to the special properties of the product

Check List No.

Supplier Process Audit

Part No. 0

Look for (Check list)

5.1.01

Suitable transporting means

5.1.02

Availabiltiy of bins (Inhouse & movement to subcontractors)

5.1.03

Protection against damage (Inhouse & movement to subcontractors)

5.1.04

Environmental influences and air conditioning

5.1.05

Expiry dates

5.1.06

Kanban / JIT

5.1.07

Defined storage area (WIP)

5.1.08

Marked containers / locations

5.1.09

Identification & marking of parts

5.1.10

Identification & marking of operation

5.1.11

Inspection & test application status

5.1.12

Route cards with Traceability

5.1.13

Batch and heat numbering

5.1.14

Protection against damage

5.1.15

No. of quantities per package / Parts Positioning in package / Work Instruction

5.1.16

FIFO controls

5.1.17

Tidiness, cleanliness & overstocking

5.1.18

Packaging- Transport worthiness (Look for drop test)

5.1.19

Work documentations (Final inspection report)

Highlights of positive Rating complaince / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsib ility

Target

#DIV/0!

#DIV/0!

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Audit rating check sheet

Brakes India Ltd., Chennai Supplier : 0

5) Packing, storage , Handling transporting and ISO 14001 Requirements

Main Element

Sub Element

Check List No.

Part No. 0

Look for (Check list)

3) ISO 14001 /

5.3.01

Is your organization IS0 14001 certified?

Consumption of Power

5.3.02

Monitoring consumption and action when they are abnormal.

4) Generation of Noise

5.4.01

Any action If Noise level exceeds 90 dB(A) ?

5.5.01

Any action If Polythene cover thickness less than 20 micron ?

5.5.02

Usage of trays for keeping barrel and containers

5.5.03

Dispose of the used oil only to Hazardous waste recyclers

5.6.01

Identify High risk Fire prone areas

5.6.02

Ensure availability of adequate different type of fire extinguishers / Fire Hydrants

5.6.03

Identify key personnel and provide adequate training for fire fighting

7) Where applicable :

5.7.01

Monitor stack emission once in a year and ensure SPM

Emission Control

5.7.02

Ensure availability of pollution control certificate.

5) Spillage / Leakage / Movement / Storage and Disposal of oiling

6) General Maintenance activities

Supplier Process Audit

5.7.03

Safety and health policy available?

5.7.04

Do you have facilty to address safety concerns raised by Employees

5.7.05

Identification of risk potential areas and keeping it away from main area.

5.7.06

Availability of first aid boxes at prominent areas.

5.7.07

Availability of procedure to report accidents

Highlights of positive Rating complaince / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsib ility

Target

#DIV/0!

OHSAS 18001 requirement

5.7.08

Availability of inhouse / outsourced medical facility

5.7.09

Availability of control system in work place which are risk potential.

5.7.10

Availability of Risk management plan on emergency systems

Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier : 0

Main Element

Sub Element

Check List No.

Supplier Process Audit

Part No. 0

Look for (Check list)

Highlights of positive Rating complaince / Areas needing 0,4,6,8,10 improvement

Avg. Rating

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Plan

Responsibili Target ty

6.1.01 Presence and absence of personnel

6) Fault analysis and continual improvements

1) Availability of Target parameters for Product, process & Monitoring compliance

6.1.02 Quality indices / failure rates, audit results etc 6.1.03

Non conformities cost / Cost of poor Quality - Records / Trend charts.Non conformity costs

#DIV/0!

6.1.04 Process characterictic values (Cp, Cpk) 6.1.05

Are Customer survey & Quality Rating Reports received from customer

6.2.01

Recording of break down times, setting time, downtimes etc, OEE (Any Kaizens)

6.2.02 Availability of cycle times / thro put times (Any Kaizens) 2) Contiual improvement on 6.2.03 Cost optimisation product and process

#DIV/0!

6.2.04 Reducing stock level

6.2.05 No of production pieces produced per hour

6.3.01 3) Carrying out corrective actions on time and check for effectiveness in the process

Recording of rejections / rework and Analysis - 7 QC Tools. (Is the Corrective and Preventive Actions initiated for In-house rejections / rework ?)

6.3.02 Implementation / Sustenance of improvements 6.3.03

CAR - Analysis status ( Look for all CAR's raised last one year)

6.3.04

Operator awareness of customer complaint (Both internal & external)

#DIV/0!

6.3.05 Improvement program from various B.I. Audits Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Full Compliance with requirements: 10; Predominant Compliance with minor NC-8; Partial with more severe NC-6; Unsatisfactory with major NC-4; No Compliance with requirement - 0. Audit Notes / Guidelines (Important Note: Where ever possible,audit by observing the actual process)

FM/SM/SA/01-Oct07

Brakes India Ltd., Chennai

Audit rating check sheet

Supplier :

0

Supplier Process Audit

0

Part No.

Adequacy and Adherence to Process Parameters in Production stage - Annexure 1 Op. No.

Operation Description

Machine, Devices, Process Characteristics Product Characteristics Tools, Jigs & Fixtures

Spec

Significant Characteristi cs

Method of insp.

Doc ref. / Process Characteristics

Actual

Observations / Points for improvement along with objective evidence

Rating 0,4,6,8,9 Reference score

FM/SM/SA/01-Oct07

9

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier :

0 Process audit report - Annex 2

Main Element

Sub Element

Highlights of positive complaince / Areas needing improvement

Rating 0,4,6,8,10

Avg. Rating

Bed flatness Scribing of bed Horizontal parallelism Ram repeatability Spindle run-out Chuck face-out Slide repeatability

Machine Management

Safety sensors Warning devices Temperature Timer Poka-yokes Periodic validation of Poka Yokes Daily qualification of Poka Yoke with NG Parts History cards PM checklist PM adherence Recording of break down times, setting time, downtimes etc, OEE Identification of accessories Stacking of accessories Critical spares

FM/SM/SA/01-Oct07

Supplier Process Audit

#DIV/0!

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Responsibi Plan lity

Target

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier :

0 Process audit report - Annex 2

Main Element

Sub Element

Highlights of positive complaince / Areas needing improvement

Rating 0,4,6,8,10

Avg. Rating

Tool ID Tool drawing

Tool Management

Tool stacking Spare tool availability RI of tool Tool service life

#DIV/0!

Tool life History cards PM checklist PM adherence Poka-yokes Tooling plan

Jigs/fixtures

Jig/fixture ID Jig/fixture drawing Jig/fixture stacking Jig/fixture calibration Maintenance frequency of wear parts History card Instrument

Instrument ID with LC Stacking Calibration History card

Gauges

Gauge ID Gauge drawing Stacking Calibration History card

FM/SM/SA/01-Oct07

Supplier Process Audit

#DIV/0!

Rating 0,4,6,8,10

Observations / Points for improvement along with objective evidence

Action Responsibi Plan lity

Target

Process audit report - Annex 2 (i)

Tool Management

Machine Management

Machine

Ave.

Bed flatness

#DIV/0!

Scribing of bed

#DIV/0!

Horizontal parallelism

#DIV/0!

Ram repeatability

#DIV/0!

Spindle run-out

#DIV/0!

Chuck face-out

#DIV/0!

Slide repeatability

#DIV/0!

Safety sensors

#DIV/0!

Warning devices

#DIV/0!

Temperature Timer Poka-yokes

#DIV/0!

Periodic validation of Poka Yokes Daily qualification of Poka Yoke with NG Parts History cards

#DIV/0!

PM checklist

#DIV/0!

PM adherence Recording of break down times, setting time, downtimes etc, OEE Identification of accessories

#DIV/0!

Stacking of accessories

#DIV/0!

Critical spares

#DIV/0!

Tool ID

#DIV/0!

Tool drawing

#DIV/0!

Tool stacking

#DIV/0!

Spare tool availability

#DIV/0!

RI of tool

#DIV/0!

Tool service life

#DIV/0!

Tool life

#DIV/0!

History cards

#DIV/0!

PM checklist

#DIV/0!

PM adherence

#DIV/0!

Poka-yokes

#DIV/0!

Tooling plan N/A - Not Applicable

#DIV/0!

#DIV/0! #DIV/0!

#DIV/0! #DIV/0!

Score 0 4 6 8 10

FM/SM/SA/01-Oct07

#DIV/0!

Status No compliance with requirement Unsatisfactory with major NC Partial compliance with minor NC Predominant compliance with minor NC Full compliance with requirement

Denoted as Not Avail.- Not available 4 6 8 Available

#DIV/0!

Audit rating check sheet

Brakes India Ltd., Chennai

Supplier Process Audit

Supplier : 0

Product Audit Report Part No. / Part Name

Critical / Significant Dimension

Spec.

Rating Rating 0,4,6, Highlights of positive complaince / Responsib 0, 4 , 6 8, Avg. Rating Action Plan Target 8, 10 Areas needing improvement ility 10

Endurance / Capability Other attributes

Dimensional Adherence

Main Element

Overall Inhouse process rejections ( For all BI parts put together): Guideline for Subelement rating - Average of rating of individual check points to be computed and in case the average falls between two rating the lower rating to be adopted. ( For example if computed rating average is 5.5 - Subelement rating to be 4) Rating: Both dimensional and visual characteristics are adequate: 10; Minor deviations in the visual charcteristics but dimensionally adequate - 8;Minor dimensional deviations -6; Major and critical dimensional deviation -4; No Compliance with requirement - 0. Capability Rating:For Ppk > 2.0 - 10 ; For 2. 1.67 - 8 ; 1.67 < Ppk > 1.33 -6 ; 1.33 < Ppk > 1.00 - 4 ; Ppk< 1.00 - 0. Note: For tool dominant processes like Moulding, Pressing etc. Cp will be considered instead of Cpk (Min. sample size 25 successive nos.) Inhouse process rejections Rating: PPM < 100 - 10 ; 100 > PPM < 1000 - 8; 1000 > PPM < 10000 -6; 10000 > PPM - 4; No PPM monitoring - 0. In house process rejections Rating (for tool dominant process like Moulding) : PPM < 5000 - 10 ; 5000 > PPM < 10000 - 8; 10000 > PPM < 50000 -6; 50000 > PPM