“Developing a quality agreement for suppliers

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“Improving Suppliers Quality Performance By Quality Agreements”

This research was conducted for

“Developing a quality agreement for suppliers

Appendices

Author:

Jeroen Prins Date:

Roden, April 15, 2005

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University of Groningen - 2 -

Appendix A – Voice of the Customer ... 3

Appendix B – CREDO ... 5

Appendix C – The quality agreement... 6

Appendix D – Supplier List ... 7

Appendix E – Suppliers scores on complexity matrix ... 7

Appendix F – Purchasing process... 9

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Appendix A – Voice of the Customer

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Customer Voice

Strategic Sourcing (Inkoop) Separation of Commercial and Quality Aspects Strategic Sourcing (Inkoop) Test Methods for suppliers product

Strategic Sourcing (Inkoop) Price?

Strategic Sourcing (Inkoop) Logistics?

Strategic Sourcing (Inkoop) Quality contract is for some suppliers better, but for some not Strategic Sourcing (Inkoop) Supplier needs to have a sort of Quality system

Strategic Sourcing (Inkoop) What kind of tests does the supplier use

Strategic Sourcing (Inkoop) Need for Q-contract for 'one-time' ordering supplier Strategic Sourcing (Inkoop) Need for Q-contract for repetitive ordering supplier Strategic Sourcing (Inkoop) ANA Code

Strategic Sourcing (Inkoop) Where does the contract enter the purchasing process?

Strategic Sourcing (Inkoop) Use the SAS as base for quality contract

Strategic Sourcing (Inkoop) Technical and commercial aspects need to be inserted in contract

Supplier Quality Assurance SAS is for External manufacturers (Medical Devices) Supplier Quality Assurance Confidence levels need to be clear

Supplier Quality Assurance Concurrence to specifications

Supplier Quality Assurance Make a contract so that the problems arise Supplier Quality Assurance Test method validation

Supplier Quality Assurance Requirements on Cordis Drawing are the same as in Q- contract

Supplier Quality Assurance Packaging requirements: Maybe more requirements Supplier Quality Assurance general aspects as: within 30 days CAPA, test data delivery

after 2 days, saving of documents for some time (FDA rules) Supplier Quality Assurance Sampling levels: AQL levels

Supplier Quality Assurance What are the consequences for the organization

Supplier Quality Assurance The Purchasing process determines the outcoming quality Supplier Quality Assurance Look at CFM 11012 for the suppliers

Quality Assurance Engineering No Change Agreement Quality Assurance Engineering Regulations of FDA: 820.75 Quality Assurance Engineering CFM 13001

Quality Assurance Engineering Gap between warning zone and noncomformance requirement could be handy

Quality Assurance Engineering Purchasing, Price and logistics not in contract Quality Assurance Engineering Certificate of Compliance for verifying orders Quality Assurance Engineering Look at SAS for subjects in contract

Quality Assurance Engineering R&R of testmethod of supplier needs to be the same as supplier

Quality Assurance Engineering Risk analysis of supplier

Quality Assurance Engineering Final Release at supplier needs to be verified Quality Assurance Engineering Process validation at suppliers

Quality Assurance Engineering Test Methods for suppliers product are very important Quality Assurance Engineering Does supplier have FMEA's

Quality Assurance Engineering CoC is very imortant if quality guarantee is at supplier Quality Assurance Engineering Sampling methodology

Quality Assurance Engineering Always ask for permission to audit if responsibilities are at supplier

Materials Management Certificate of Analysis needs to be 100% correct Materials Management Certificate of Compliance needs to be 100% correct

Materials Management Inspection reports conform Quality Agreement or Vice versa Materials Management Specifcations about correct labelling

Materials Management Labelling and adressing needs to be correct Materials Management Labelling conform inspection report

Materials Management Packaging

Materials Management Clear requirements about certificates sent by suppliers Materials Management Test Methods for suppliers product

Materials Management Lay-out contract: Correct Date

Materials Management Checklist to guarantee 100% communication between SQA, SSD, MM and supplier

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Appendix B – CREDO

Our Credo

We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.

In meeting their needs everything we do must be of high quality.

We must constantly strive to reduce our costs in order to maintain reasonable prices.

Customers' orders must be serviced promptly and accurately.

Our suppliers and distributors must have an opportunity to make a fair profit.

We are responsible to our employees,

the men and women who work with us throughout the world.

Everyone must be considered as an individual.

We must respect their dignity and recognize their merit.

They must have a sense of security in their jobs.

Compensation must be fair and adequate, and working conditions clean, orderly and safe.

We must be mindful of ways to help our employees fulfill their family responsibilities.

Employees must feel free to make suggestions and complaints.

There must be equal opportunity for employment, development and advancement for those qualified.

We must provide competent management, and their actions must be just and ethical.

We are responsible to the communities in which we live and work and to the world community as well.

We must be good citizens – support good works and charities and bear our fair share of taxes.

We must encourage civic improvements and better health and education.

We must maintain in good order the property we are privileged to use, protecting the environment and natural resources.

Our final responsibility is to our stockholders.

Business must make a sound profit.

We must experiment with new ideas.

Research must be carried on, innovative programs developed and mistakes paid for.

New equipment must be purchased, new facilities provided and new products launched.

Reserves must be created to provide for adverse times.

When we operate according to these principles, the stockholders should realize a fair return.

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Appendix C – The quality agreement

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Appendix D – Supplier List

Roden SUP#

Name Type supplier supplied material

34200 Alverimport item corrugated boxes

24060 Americhem item Color concentrate

52810 ASHLAND PLASTICS BENELUX B.V. ( DSM BEHO)

item poly ethyleen; polypropyleen

9851 Atofina item nylon compound

35650 Sentega Etiketten (Avery) item label

78880 B.BRAUN NPBI MEDICAL B.V. item pyrogeen vrij water; distilled water

35199 BEHO PLASTICS item propyleen

64001 BERGSTEIN HANDELSMIJ B.V. item ink etc.

79401 BOOM B.V. item heptaan; ethanol

9689 BRENSCHEIDT P/A SWILDENS item mandrelwire

35341 CARMEDA (se) item stent

24113 Carolina color item Color concentrate

3989 CCMP item uv lijm; uv curable adhesive

15600 CHROMOS B.V. item mounting card

12719 CLAIRSON INDUSTRIES CORP item him hub

12905 CONNECTICUT HYPODERMICS INC. item proximal shaft assy; stainless steel canulla 12876 CONTECH MEDICAL INT. item dispenser tube; protective tubing

12962 CORDIS - NDC item trap-ease-pvcf

25013 Creganna item metal components

13086 DEGUSSA-HULS (voorheen Creanova) item trogamid; nylon vestamid

13101 DEROYAL EUROPE LTD (PACS) item manifold kit; press mon line

28138 Desimo item Grenadine rode kleurstof

12722 DYMAX EUROPE GMBH DEM (via CCMP N.V., vendor nr.3989)

item uv lijm; uv curable adhesive

12907 DYNATEK DALTA SCIENTIFIC INSTR item latex tubing

12712 EFD inc. item flushing needles

77310 ETIFLEX B.V. item label

12858 FOSTER WEST CORPORATION item nylon compound

16816 getPLASTIC.com,INC. item escorene LD

9682 HOEKLOOS pa WORTELBOER B.V. item ethyleen oxide 57009 KAPPA VAN DAM GOLFKARTON B.V. item shipping box

12689 KEY PACKAGING item tip tray

12769 KEYSER & MACKAY item cleaning fluid 9s10560 9837 LAKE REGION MAN. COMPANY INC. item guide wire 12853 LAKE REGION MANUF.CO. LTD item guide wire 35328 MANGAR INDUSTRIES INC item foil pouch

12714 MARKWIK CORP item ID band

19816? Medefab item ID band

3984 MEDELEC MINIMECA S.A. item nozzle; tube; marker band

12819 MEDEX MEDICAL INC. item stop cock

58540 MELDON PLASTICS B.V. item tube

12730 MICRO GUIDE (UTI) item stylet/ stiffening wire

12882 Micro-med (UTI) item container plug, rod

92011 NECUM DRUKKERIJ BV (VJD Necum) item instruction for use 58040 NELIPAK THERMOFORMING B.V. item stent tray; tip tray; tray 12745 NOBLE-MET LIMITED (UTI) item marker band

13018 NORMAN NOBLE item stent

35549 OAKITE PRODUCTS INC item dynadet

3980 PERFECSEAL LIMITED item pouches

33342 PETER HOLLAND B.V. (ook vendor#

4165)

item J-straightner

49004 POLYFLUOR BENELUX BV item ptfe sleeve; co-extrusion tube

46120 POLYMERLAND BENELUX item compound

12747 Polyone (before: M.A. HANNA COMPANY,item compound

12833 PUTNAM PLASTICS CORP item crimp tube

3982 SASSENSCHEIDT UND CO.GMBH item braidingwire; wire 304SST 27008 Star Guide Europe item stiffing wire, stylet

12922 SURMODICS INC. item PA solid

86000 Sylvaphane (via Hettinga) item bags

21491 TOPA Verpakkingen BV item packaging products 12911 UNIFORM TUBES, INC. (UTI) item marking band; introducer tube

4258 UNISIS CORP. item Needles (Packaged & Bulk) 86002 VRIES J.G. DE DRUKKERIJ B.V. item carton

9841 WITEC FIJNMECHANISCHE TECHNIEK item E7128925 storage tube

19471 WYETH-AYERST item rapamycin E7137825

12123 ZEUS INDUSTRIAL PRODUCTS item PTFE tubing, FEB tubing

21676 NDC item stents

16700 Medistad Medical b.v. item hydrolyser bags

28353 Spectrum (UTI) item introducer tubes

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Appendix E – Suppliers scores on complexity matrix

Suppliers

NPD Strategy Implant Duration Intended Use Sterility Regulatory Classification

Technology Maturity

Technology / Expertise

Creganna 9 9 9 3 9 9 9

WYETH-AYERST 9 9 9 3 9 9 9

NORMAN NOBLE 3 9 9 3 9 9 3

NDC 3 9 9 3 9 9 3

MANGAR INDUSTRIES INC 3 0 9 9 9 3 3

PERFECSEAL LIMITED 3 0 9 9 9 3 3

DYNATEK DALTA SCIENTIFIC INSTR 9 3 9 3 3 3 3

LAKE REGION MAN. COMPANY INC. 3 1 9 3 9 3 3

LAKE REGION MANUF.CO. LTD 3 1 9 3 9 3 3

CORDIS - NDC 1 9 9 3 3 3 3

CLAIRSON INDUSTRIES CORP 3 1 9 3 3 3 3

CONNECTICUT HYPODERMICS INC. 3 1 9 3 3 3 3

DEGUSSA-HULS (voorheen Creanova) 3 1 9 3 3 3 3

UNIFORM TUBES, INC. (UTI) 3 1 9 3 3 3 3

UNISIS CORP. 3 1 9 3 3 3 3

Spectrum (UTI) 3 1 9 3 3 3 3

DEROYAL EUROPE LTD (PACS)

3 1 3 3 9 3 3

POLYFLUOR BENELUX BV

1 1 9 3 9 1 1

MARKWIK CORP 1 1 9 3 9 1 1

Medefab 1 1 9 3 9 1 1

ASHLAND PLASTICS BENELUX B.V. ( DSM BEHO)

1 1 9 3 3 3 3

Atofina 1 1 9 3 3 3 3

BEHO PLASTICS 1 1 9 3 3 3 3

FOSTER WEST CORPORATION 1 1 9 3 3 3 3

getPLASTIC.com,INC. 1 1 9 3 3 3 3

POLYMERLAND BENELUX 1 1 9 3 3 3 3

Polyone (before: M.A. HANNA COMPANY, INC. 1 1 9 3 3 3 3

SURMODICS INC. 1 1 9 3 3 3 3

PETER HOLLAND B.V. (ook vendor# 4165) 1 1 9 3 3 3 3

BERGSTEIN HANDELSMIJ B.V. 1 1 3 3 9 3 3

MICRO GUIDE (UTI) 3 1 9 3 1 3 3

ZEUS INDUSTRIAL PRODUCTS 1 0 9 3 3 3 3

Americhem 1 1 9 3 1 3 3

Carolina color 1 1 9 3 1 3 3

MEDELEC MINIMECA S.A. 1 1 9 3 1 3 3

NOBLE-MET LIMITED (UTI) 1 1 9 3 1 3 3

NELIPAK THERMOFORMING B.V. 3 0 9 3 3 1 1

Medistad Medical b.v. 3 1 3 3 3 3 3

EFD inc. 3 0 3 3 3 3 3

CHROMOS B.V. 1 0 3 3 9 1 1

SASSENSCHEIDT UND CO.GMBH 1 1 9 3 1 1 1

Star Guide Europe 1 1 9 3 1 1 1

CONTECH MEDICAL INT.

1 1 9 3 1 1 1

KEY PACKAGING 1 0 9 3 1 1 1

MELDON PLASTICS B.V. 1 0 9 3 1 1 1

ETIFLEX B.V. 1 1 3 0 9 1 1

NECUM DRUKKERIJ BV (VJD Necum) 1 0 3 0 9 1 1

VRIES J.G. DE DRUKKERIJ B.V. 1 0 3 0 9 1 1

HOEKLOOS pa WORTELBOER B.V. 1 0 9 0 0 1 1

KEYSER & MACKAY 3 1 3 1 1 1 1

CCMP 1 1 3 3 1 1 1

DYMAX EUROPE GMBH DEM (via CCMP N.V., vendor nr.3989) 1 1 3 3 1 1 1

TOPA Verpakkingen BV 1 0 3 3 1 1 1

Sentega Etiketten (Avery) 1 0 3 1 1 1 1

OAKITE PRODUCTS INC 1 1 1 1 1 1 1

BRENSCHEIDT P/A SWILDENS 1 0 3 0 0 1 1

B.BRAUN NPBI MEDICAL B.V.

1 1 1 0 0 1 1

Alverimport 1 0 0 1 0 1 1

BOOM B.V. 1 0 1 0 0 1 1

KAPPA VAN DAM GOLFKARTON B.V. 1 0 0 0 1 1 1

Sylvaphane (via Hettinga) 1 0 0 0 0 1 1

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Appendix F – Purchasing process

Im pl em ent at io n Label in g is “Q ua lif ie d” Devel op m en tLab el in g is “U n- Q ual ifi ed” Fe as ib ilit y /I te m La be lin g is “E ng inee rin g” or “U Q ”

Supplier Process Optimization

Supplier Verification / PQ Comment : Use Supplier

PQ units in subsequent process PQ’s where applicable.

Supplier PPQ Supplier Equipment/

Process Capability Initial Supplier

Process Risk Assessment

Supplier Prototypes / Initial

Units Cordis Specification

Package

Initial Supplier Process Documentation

Approve Joint Supplier/Cordis

Strategy for manufacturing and

testing

Prototype/

Feasibility Testing &

Report Link to

Design Control Validationor

Activities

Supplier + Item Status Change to

“Qualified”

Supplier Transfer to Manufacturing

Review

Receiving Inspection Strategy

First Article Inspection

Supplier Qualification Readiness Review

Comment : Use Supplier PPQ units in subsequent

Cordis DV/PPQ’s where applicable.

Finalized Service and/or Supply Agreement/Contract Strategy & Results

Review ---

Item + Supplier Status Released

as “UQ”

Service Agreement and/or

P.O.

Cordis Confidentiality Agreement

Supplier Monitoring

Strategy Spec. Package

Review

Supplier Activities Document

N/A to Low Risk

“Developing a quality agreement for suppliers

“Improving Suppliers Quality Performance By Quality Agreements”

This research was conducted for