3A: CFF 11-026 (revision 1)

(1)

1: The SIPOC (Supplier Input Process Output Customer

NPD/PT SQA Mat. Man.

Q-document No-change agreement CVP/CV Signed CTS Updated QSIL CVP replace with inspections

Purchasing PET/PT RI Mat. Man Inspectionreport Follow up audits Supplier rating

NPD/PT PET SQA

(MRR) Disqualify supplier Update spec. /inspectionprotocol

RI Purchasing PET/PT Mat. Man

Purchasing SQA Specification Signed CTS No-change agreement Supplier Profile form Assessment Report

Supplier History filePurchasing NPD/PT Mat. Man

Qu al if ic at io n of S I- co m b in at ion M oni to rin g Qu al if ie d Su pp li er s an d It em s

Qu al if ic at io n o f Supp li er s

Input Supplier OutputCustomer

Pro cess

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2: The Voice of the Customer

Customer Voice

Qualification of suppliers Qualification SI combination Monitoring Qualified Items process clearness assurance interaction learning speed process clearness: interpretation overview functionality

1 Packaging Technology

The data given on the Q-Document is not self-explanatory

1 1 1

How the user should obtain certain data for completion of the Q-document is not clear

1 1 1

Instructions for filling out a Q- document are hard to find in the computer-system

1 1 1

For new employees the procedures can't be found, this requires experience

1 1 1 1 1

In the Q-document there are no triggers for impossible combinations

1 1

The quality systems of the US don't match with those of Roden

1 1 1 1

The quality systems of the suppliers and Cordis are not tuned

1 1 1 1

Procedures are not set down in records, the actions taken are based on

experience

1 1 1 1 1

11 PET-QA If the material is inspected very late, and there is no reserve, it is possible that production will be at a standstill

1 1 1

12 PET-QA CVP and spec do not match. The spec says a dimension is not critical, but RI has to inspect on this dimension

1 1 1

13 PET-QA The PET has to deal with MRR's, because there are mistakes in specs, wrong products and irregularities in products

1 1

14 PET-QA The inspection criteria from QA are corrected on the spec. The receiving inspection does not comply

1 1 1

15 Purchasing It is difficult to trigger engineers to contact purchasing

1 1

16 Purchasing Through the turnover of employees, there is no good knowledge of the procedures

1 1 1 1 1

17 Purchasing It is not always obvious if suppliers should be qualified

1 1 1

18 Purchasing During the transition period of items for usage on production, an order can be placed. The safety net, RI, is too late

1 1

19 Purchasing New employees do not always know how a Q-document should be filled out.

1 1 1

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20 Purchasing There is no assurance that during the NPD-course an action towards the supplier is taken (qualifying)

1 1 1

21 Purchasing For planner/buyer codes purchasing is not always contacted, the items are delivered at the wrong location.

1 1

22 Purchasing For the introduction of new items so much is unknown, at what point a trigger should be placed?

1 1 1

24 QA- engineer For a new revision a supplier does not have to be re-qualified

1 1

25 QA- engineer Sometimes an order is already placed for a new (not yet approved) revision, this is not a quality, but an economical risk

26 QA- engineer The analysis code is not always changed when an item is transferred to the PET, the item can't be used in production. Not on QSIL.

1 1

29 QA- engineer Q-documents are often filled out wrong 1 1 1 30 QA- engineer References to underlying specifications

are not always there

1 1

31 QA- engineer It is not clear when a COC should accompany a lot

1 1 1 1

32 NPD- engineer

There is no trigger for an engineer to contact purchasing in an early stage, the ordering of items takes more time

1 1 1

33 NPD- engineer

There is no hard coupling between a CVP and an risk analyses

1 1

34 NPD- engineer

It is not exactly clear when a supplier should be qualified

1 1 1

35 NPD- engineer

Large lots entering on CVP with a small demand, stay unqualified

1 1

36 NPD- engineer

There is not a solid argumentation for lots to enter on CVP three times

1 1

37 NPD- engineer

For NPD the placement of an item on QSIL has no value, while they make the CVP's

1 1 1

38 QA- engineer The AQL-level used by Cordis is difficult to translate to a quality level at the supplier

1 1

40 Purchasing There are loose areas for deciding to qualify a supplier

1 1 1

41 Purchasing Actions are drawn back, because engineers did not contact purchasing

1 1 1 1

43 Purchasing It is not clear what should be done in the process of introducing new items

1 1 1 1 1

44 Purchasing Specifications are not clear, items brought up for discussion can be ordered

1 1

45 Purchasing The COC accompanies every received lot, can this be covered by a contract?

1 1 1 1

46 Purchasing Purchasing should play an evident role in the process of introducing new items.

1 1 1 1

47 Purchasing SQA should play an evident role in the process of introducing new items

1 1 1 1

48 Purchasing The tests engineers want should be challenged by SQA

1 1 1

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49 Purchasing SQA does not take the no-change agreement in account when they audit a supplier

1 1 1 1

50 Purchasing The qualification of supplier takes place immediately

1 1

51 Purchasing The procedures for introducing a new item are not clear, the role of

purchasing is not evident

1 1 1 1 1

52 Purchasing A lot of work is done twice, because an engineer contacts the supplier without contacting purchasing

1

53 Purchasing The consequence of not contacting SM is a supplier who can make the product, but cannot deliver according to spec

1 1

54 Purchasing The Phase-Out of products can cause a lot of unmarketable items

1 1

55 Purchasing What's lacking is a checklist, small changes cause a lot of mistakes

1 1 1 1 1

56 Purchasing An overview of actions to be taken is lacking, who should deliver what and who is responsible

1 1 1 1 1

57 Materials Man.

Engineers are not triggered to contact MM, delays are the result: the CTS is missing

1 1 1 1 1

58 Materials Man.

Laxity of an engineer to complete the Q-document result in a lot of MRR's when an order is already placed

1 1 1

59 Materials Man.

CPDM works with electronic signatures, the pressure to sign documents is lower

1 1

60 Materials Man.

A lot of communication with the supplier, changing the order and an enlarged chance mistakes are made are consequences/risks of a no-no order

1 1 1

61 Materials Man.

Procedures should not deal with mark up revisions, this would lower the flexibility

1 1 1 1

62 Materials Man.

A short lead-time causes tensions with the quality system, MM wants to be flexible

1 1 1

63 Materials Man.

Is it necessary that so many people sign for a Q-document?

1 1 1

64 Materials Man.

Does the supplier also take the last changes of the draft into account when signing the CTS, it can't be checked.

1 1 1 1 1

65 PET-ME The AQL level only determines the size of the sample, not the accuracy

1 1 1 66 PET-ME Items declared unfit by RI are

declared Use As Is by the PET. The spec or the inspection report should be adjusted

1 1 1

67 PET-ME Test reports for the suppliers are too extensive. NPD already transferred the items to the PET

1 1

68 QA- engineer

There is no guideline for a spec to comply with

1 1 1 1 1

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69 PET-ME There are a lot of bad specs, old specs are used for making new ones

1 1 70 PET-ME Specs are incomplete 1 1 1 71 PET-ME A CVP that is not signed by RI, has

been put in the system

1 1 72 QA-NPD De basic procedures are clear, but

the procedures underneath are not clear

1 1 1 1 1

73 QA-NPD Procedures are open to one's own interpretations

1 1 1 1 1 74 QA-NPD New procedures are placed on the

internet one must keep track of the changes and decide if training is necessary

1 1 1 1 1

75 QA-NPD The contents of a spec is free, there are no requirements to be met

1 1 1 76 QA-NPD How a spec should be drawn up by

NPD and the way SQA handles them do not match

1 1 1 1

77 QA-NPD NPD and SQA have different interests, through resource

problems, NPD is the initiator in de decision of what to test

1 1

78 QA-NPD Decision procedures shouldn't take this much time

1 1 1 1 79 QA-NPD Items from Miami aren't always

handled in the right way, dock to stock is not possible due to different analyses codes

1 1 1

80 QA-NPD A software supplier doesn't appear on the decision form for qualifying a supplier

1 1 1

81 QA-NPD There is a gap between what one should do and what one does, the definition of one's knowledge of procedures is difficult to determine

1 1 1 1 1

82 QA-NPD Comparable specs have different shelf lifes

1 1 1 1 83 QA-NPD Documentation as foundation is not

always present, copy from other directories

1 1 1 1

84 QA-NPD It is questionable if engineers who know the procedures are competent in carrying them out

1 1 1

85 QA-NPD The changing procedures for CFD- documents are very complicated

1 1 1 1 1 86 QA-NPD A signed COC is not a guarantee for

a good product

1 1 1 87 QA-NPD Taking samples is only a good

means if the process can be trusted

1 1 88 QA-NPD SQA takes failures of supplier

lightly

1 1

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89 QA-NPD When a supplier is being audited, are the defect classes taken into account?

1 1 1 1

90 QA-NPD Items from Miami aren't being inspected, through different inspection protocols it is necessary

1 1 1 1 1

91 QA-NPD When executing an audit, are the AQL levels taken into account?

1 1 1 1 92 Packaging

Technology

The process captures too much, for artwork a CTS is not necessary

1 1 1 93 Packaging

Technology

Making a CVP is a nasty standard administrative action. For inspection reports there are no standards, they are copied from former inspection reports

1

Through repetition the Q-document is not difficult to fill out

1 1 1

Miami documents in a different way, they don't use DINO, but they put their documents on the internet

1 1 1 1 1 1

96 Purchasing When specs contain qualitative problems the component should be improved, you ask something from the supplier

1 1 1 1

97 Purchasing When there are structural issues with a supplier that can't be solved, another supplier is used

1

98 Purchasing SQA doesn't learn how to improve sourcing, they don't keep items that are declared unfit through damage

1 1

99 Purchasing There is no integral assurance of the systems

1 1 1 1 1 100 Purchasing The assurance of SQA in the

development, should take place after the development

1 1 1 1 1

101 Purchasing RI is reactive, they don't think about sequel steps

1 1 1 102 Purchasing How should a specification be

assured, Dock to stock should be the basic assumption not RI

1 1 1 1

103 Purchasing A lot of people have to sign for a document, but there is no

communication with the persons concerned

1 1

104 Purchasing There is pillarization among the different departments

1 1 1 1 105 Purchasing The strength of purch. used to be

reordering, with large systems.

Flexibility and creative solutions ask for an integral approach

1 1 1 1

106 Purchasing Checklists should be made, in order to have an overview of what should be done

1 1 1 1 1

107 Purchasing BPCS is not users friendly 1 1 1 1 1

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108 Purchasing Everything has to be documented, with a continuous changing work force. Changing procedures takes a specialist

1 1 1 1 1

109 Purchasing An engineer with a good idea should convince the purchasing that the price is reasonable

110 Purchasing What are the features of a good supplier?

1 1 1 1 1 111 Purchasing SQA has to reveal the rules, they

should not be a safety net

1 1 1 1 1 1 112 Purchasing The CTS and the COC is a double

request of the same

1 1 1 1

113 Purchasing There are a lot of unclear specs, that are not functional enough

1 1 1 1 114 Purchasing The methods of measurement of

Cordis and the suppliers do not match

1 1

115 Purchasing Through pillarization a lot of mistakes detected in production are not given feedback on

1 1 1 1 1

116 Purchasing SQA does not recognize differences between mistakes, that's why it's not possible to learn from mistakes

1 1 1

117 Purchasing The system asks a lot of questions for a simple answer (CFF11-026)

1 1 1

118 Purchasing The grades of the supplier ratings do not cover everything. Improvements made by suppliers are not taken into consideration

1 1 1

120 Purchasing When do you put something on QSIL?

1 1 1 1 1 121 Purchasing The critical and non-critical

dimensions are indicated, but they are not concentrated on

1 1 1 1

23 31 29 43 35 29 4 9 7 26 10

43

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3A: CFF 11-026 (revision 1)

Type of Purchase:

1

A physical item or material such as tools, capital equipment, disposable apparel,

lubricants, cleaners, printed materials, software, graphics, components, etc. y Go to Green Section (Suppliers)

2

A service such as cleaning, repair, calibration, gown rental, pest control, preventive maintenance, laboratory testing, clinical trail monitoring, transportation, etc.

y Go to Blue Section (Service Suppliers)

What is Supplied?

3

Consultation such as brainstorming, training, product or equipment design, design review,

auditing y Go to Yellow Section

(Consultants)

The supplied items are:

4

Single time purchases such as equipment, tooling or software that may have direct impact upon design control, manufacturing, release of product that will be validated by Cordis prior to use.

y

Supplier not required on Approved Service

Supplier List

5

Purchases of equipment, tooling or software that may have direct impact upon design control, manufacturing, release of product that will not be validated by Cordis prior to use.

6

Components, materials or printed material that will become part of a finished, packaged

product or is distributed to the end user even at no cost.

7

Cleaners, lubricants, disinfectants, etc. that come in contact with product, or production

surfaces contacting products or packaging.

8

Apparel, adhesive mats, particulate counters, etc used to maintain or assess the cleanliness

within a clean room, water system or other controlled system.

9

Pre-printed labels, software or other devices used to maintain identification, material

status or traceability during manufacture or warehousing.

10

Chemicals, biological, filter media, or other test material that effect design decisions or

decisions to release product.

Suppliers of components, products, and materials

11

Are national or international standards provided by a recognized organizations as NIST,

ANSI, USP, NIBSC. etc

The services supplied are:

12

The service may have direct impact upon design control, manufacturing, release of product and will be completely checked, verified or validated by Cordis during or after rendering of the service and the verification is documented in department or company records.

y

Supplier List 13

The service may have direct impact upon design control, manufacturing, release of

product and will not be completely checked, verified or validated by Cordis.

14 Pest control services that are structural (inside and at perimeter of buildings).

15 Services that transport our products, warehouse or distribute Cordis finished products.

16

Service performed upon equipment listed in documented schedules (preventive maintenance, calibration schedules, etc.), or service/repairs upon product manufacturing equipment, clean room equipment, water systems, etc. that will not be subsequently re- validated. .

17

Services that translate, store, microfiche, computerize or dispose of controlled documents,

graphics or drawings.

18

Physical, analytical or biological testing services the results of which are used to support

design control, routine product release or complaint investigation.

19

Services that maintain product aging samples, monitor aging chambers or other

environmentally controlled areas.

20 Services that conduct, monitor or analyse data from clinical trials.

Service Suppliers

21 Suppliers that service a Cordis product after distribution.

The consultant will:

22

Provide equipment designs, product designs, software designs or test methodology that

will not be validated by Cordis prior to implementation.

23

Participate in design review, complaint investigation, validations, clinical trials or other

regulated activity where their participation will be referenced in resulting documentation.

24

Provide training to help associates comply with a requirements of the FDA, ISO, or the

Cordis quality system.

25

Participate in the design of Cordis' quality system, conduct audits or monitor activities

necessary to comply with FDA regulations.

Consultants

26

Design work areas that affect product flow, material handling, manufacturing space,

material or product storage.

None Apply 27

None of the above statements apply since there is no possibility that this purchase will have a direct effect upon the quality of products, labelling, the manufacturing environment or the quality systems of Cordis.

y

Supplier List

Status: Supplier not required on Approved Service Supplier List

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3B: CFF 11-026 (revision 2)

Supplier Name &

Address:

Detailed description:

Site:

Answer X if the statement applies

Product (All physical purchases) x Go to question 1

Type of

purchase: Service (Consultants & Contractors) x Go to question 6

PRODUCT

Question

1

Is the product used for items intended for the market and not solely in the

engineering stage

YES x Go to question 2

NO x Do not qualify supplier

2Is the purchased product part of the final product?

YES x Qualify supplier

NO x Go to question 3

3

Does the purchased product come in contact with the product intended for the

market?

YES x Go to question 3A

3ADoes the purch. product leave traces on the product (answering should be based

on laboratory research)?

4Does the product influence Fit, Form, and Function?

YES x Go to question 5

5What type of product is it?

Consumable x Qualify supplier

Durable x Go to question 5A

5AIs the product validated?

YES x Do not qualify supplier

NO x Qualify supplier

SERVICE

Question

6

The service may have direct impact upon design control, manufacturing, release

of product:

YES x Go to question 6A

6AIs the service completely checked, verified or validated?

YES x Do not qualify supplier

7Can the service affect the quality of the final product?

Requestor Name: Dept #:

Signature of Requestor: Date:

APPROVAL SIGNATURES

SQA: Date:

SM: Date:

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4: Warning Letters

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.

Federal agencies are advised of the issuance of all Warning Letters about devices so that they take this information into account when considering the award of contracts.

• http://www.fda.gov/foi/warning_letters/g1942d.pdf

Your firm failed to establish and maintain the requirements, including quality requirements that must be met by potential suppliers and contractors as required by 21 CRF 820.50(a)(1).

For example, your purchasing control procedures fail to verify all specification for vendor supplied devices and/or components, your firm failed to assure adequate process validation of molding of breast localization needle hubs at the contract manufacturer, and you failed to require periodic supplier audits.

Audit your supply chain as part of the qualification of your supplier

Failure to perform at least one specific identity test on each incoming lot of OTC drug product component. 21CFR211.84(d) Specifically your firm relies on a Certificate of Analysis from the raw material supplier(s) without performing at least one quantifiable test to verify the accuracy of the supplier(s) Certificate of Analysis. No vendor validation has been performed.

Failure to establish and maintain the requirements, including quality requirements, that must be met by supplier 21CFR820.50. For example, your firm has not specified quality

requirements for suppliers, maintained lists of approved suppliers, and developed written procedures describing how suppliers are evaluated for quality acceptance requirements.

Failure to maintain procedures to ensure all purchased or otherwise received products and services conform to specified requirements 21 CFR820.50. For example, your firm failed to ensure that the supplier of the main computer board documented all of the required test results to indicate the supplier’s quality acceptance of the computer boards manufactured and

delivered to your firm.

Failure to establish and maintain procuress to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR820.50. For example, vendor audits or verification of Certificate of Analysis information has not been performed for suppliers of raw material.

• http://www.fda.gov/foi/warning_letters/m2290n.pdf

Failure to establish and maintain adequate purchasing control procedures, e.g. current procedures do not require documented evaluations and selections of potential vendors based on established criteria, there are not contracts between International Medical and vendors

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providing for notification of changes in product or services that may adversely affect the quality of the finished device.

Failure to conduct annual evaluations of your contract sterilizer and laboratory, per instructions contained in your SOP 21CFR820.50

Failure to establish and maintain procedures to ensure that all purchased or otherwise contracted products or services conform to specified requirements as required by

21CFR820.50(a)(1),(2)&(3). For example, there is no written agreement or contract that establishes quality requirements that must be met by suppliers or contractors; that defines the type and extent of control to be exercised over the product or service; and there is no record maintained listing acceptable suppliers or contractors.

Failure to establish and maintain procedures to ensure that all purchased or otherwise contracted products or services conform to specified requirements as required by

21CFR820.50. For example, although the adhesive bandages are labeled as sterilized, invoices received from the supplier do not state that products are sterile, and there is no other

documentation stating such.

Failure to, validate computer software for its intended use according to an established

protocol when computers or automated data processing systems used as part of production or the quality system, as required by 21CFR280.70

You have established and maintain appropriate procedures for acceptance of all incoming components currently used in your device.

Failure to establish and maintain procedures to ensure that all purchased products conform to specified requirements. For example, a contract manufacturer has modified a component and the manufacturing process for another different component, without approval by Osmonis.

http://www.fda.gov/foi/warning_letters/g1860d.pdf

Failure to establish and maintain the requirements that must be met by suppliers, contractors, and consultants, as required by 21CFR820.50(a). For example, MIT hired a consultant to design and evaluate the system used in QC processing for testing the impedance, resistance, and continuity of …; however, you failed to:

A: Establish and maintain requirements to be met by the consultant

B: Document the evaluation of the consultant’s ability to meet any quality requirements or the specific needs of MIT

Your response of May 4, 2001, is inadequate because no procedure was submitted establishing the requirements for a consultant and no documentation was provided that evaluated and approved the selection of the consultant.

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Your firm failed to establish and maintain procedures to ensure that all purchased or otherwise received product or services conform to specified requirements as specified by 21CFR820.50 for example shrink tubing provided by your supplier was the wrong size and the discrepancy was not discovered until it was required during processing.

COA’s received from suppliers of sterilization gases have not been verified and documented

Adequate quality requirements that must be met by contractors are not established.

Specifically there has been no audit of contract laboratories that provide services for the verification of sterility of plastic strip and flexible bandage

Failure to conduct periodic audits of suppliers as specified in the QA program

Failure to establish an agreement between the firm and contract manufacturer, sterilizer, and packer of Vitreon, to notify the firm of ‘changes’ in the product or manufacturers

specifications

Incoming product was not always inspected or tested as conforming to specified requirements.

Certified suppliers work instruction, dated 12/2/98 requires that once the supplier was de- certified, all future lots received would be sent to inspection.

COC received on a routine basis did not contain the required acceptance criterion.

Your firm failed to establish a formal agreement with your contract firm, regarding quality issues, performance specifications, engineering changes, complaint handling or supplier audits.

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5: Explanation of the Quality System Regulation

A prerequisite to complying with a regulation is a clear understanding of its content. The FDA recognised this fact and supplied guidance on the QSR. In this section the intent of 21 CFR 820.50 Purchasing controls is explained (Medical device quality system manual, 1996).

Supplier Qualifications

A major factor in obtaining high quality components is the selection of suppliers. Although a manufacturer’s knowledge of supplier operations may be limited and information about operations difficult to obtain, the GMP requirement that a manufacturer is responsible for quality remains undiminished. To the maximum extent feasible, selection and qualification of suppliers by audits, performance analysis, etc., should be part of a quality system. If the manufacturer does not have the capability to test components for conformance to specifications, then supplier test data or outside lab results are acceptable provided that components are tested and inspected in a statistically valid manner to show their acceptability for use in the finished device. Any outside test results should be accompanied by relevant raw data used for the test so that judgments of authenticity may be made by the finished device manufacturer. Excluding a supplier whose components are unreliable from supplying components may help prevent problems with the final device and is certainly worthwhile as a cost reduction effort.

Acceptance Criteria

Manufacturers should have specific acceptance criteria for components. Acceptance criteria are the attributes of a components that determine its acceptability, such as appearance, dimension, purity performance characteristics, etc. Typically, acceptance criteria are made a part of the inspection/test procedure.

If components or the suppliers of the components have a history of good performance, the components may be accepted for use after a visual check to assure they are the items intended and that they are not damaged or contaminated.

Components, which need only a visual inspection, may be accepted using the purchase order data as acceptance criteria. The purchase order and/or receiving ticket should at a minimum contain the following information:

• Name of supplier

• Description of the component or other product; and

• Quantity shipped

For a standard component, the catalogue number may be used as a description. QA personnel should determine whether the use of any “abbreviated” criteria are adequate during their audit of production rework, history records, complaint files, and service records.

Testing and inspection of product

The minimum acceptance activity per current practice requires that all incoming components and other product receive at least a visual inspection for contamination and/or damage and be identified as the component specified on the purchase order. A manufacturer accepting the

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product has the discretion to determine when and where product should be inspected, sampled, and tested for conformance to specifications depending upon the risk that failure of that component may pose. As appropriate, product may be tested and/or inspected by:

• The supplier

• When received

• During manufacture of the device; or

• As part of the finished device.

Manufacturers who decide not to sample or test specific components should be able to justify that decision based on such factors as knowledge of the supplier’s previous performance in providing high quality components, the component performance history, and application of the components in the device.

Manufacturers may rely on component suppliers to conduct testing if the manufacturer specifies or is knowledgeable about the supplier’s quality system, particularly the inspection and test programs and the supplier has specifications that properly define the manufacturer’s acceptable device master record requirements for component specifications.

If components are tested by the supplier, acceptance of components can be based on certification and review of test data submitted by the supplier for the specific components provided. Certification should accompany each lot of components. When certification is used, the manufacturer should periodically verify the validity of the certification through an assessment of the supplier.

Where historical data shows that certain components or other product have been substandard and resulted in a device failing to meet specifications, or where performance history has not been established, specific steps should be taken to assure components meet specifications.

Typically, this task is accomplished by sampling and testing each lot of components to assure that the components meet specifications. Where appropriate, all significant or high risk components should be sampled and tested.

Manufacturers may test entire assemblies of components rather than individual components.

If, however testing an assembly cannot assure fitness-for-use of the components, then components should be tested on an individual or lot basis, whichever is appropriate.

When using a contract laboratory to test production components, the laboratory becomes an extension of the device manufacturer’s quality system. The device manufacturer is responsible for assuring that the contractor’s test and inspection procedures are acceptable.

This assurance maybe obtained by audits of the laboratory, by the lab staff, and by the finished device manufacturer.

Inspection and testing will not improve the quality of components or other product; however, if the inspection and testing is appropriate and performed adequately, these activities can be used to prevent or significantly reduce the use of low-quality or defective product. Through feedback into the overall quality system, data on products will help identify basic causes of problems and lead to solutions. If problems are found, actions such as design changes, tighter acceptance criteria, supplier assessments, or change of suppliers may be appropriate.

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Acceptance and Rejection Records

Adequate records shall be maintained to provide objective evidence that components were inspected and accepted, or rejected. These records are a part of the device history record and should be maintained (820.80 (b)).

Typically, acceptance/rejection records should contain:

• Acceptance or rejection documentation;

• Number and type of deficiencies;

• Quantity approved;

• Quantity rejected; and

• Nature of corrective action taken.

Obsolete, deteriorated, and Rejected Components

Obsolete, deteriorated, and Rejected Components shall be identified as such and be placed in a separate quarantine area or specially identified area to prevent mix-ups. If practical, components should be individually identified as rejects. Where is not feasible to tag each rejected component, as in the case of transistors, bolt, bottles, etc., containers or packages of rejected lots should be clearly marked and otherwise appropriately segregated form accepted components. See 820.85 for clarification. Manufacturers should determine the need for a separate written procedure for handling these components based on the size of the manufacturer and complexity of their devices and operation. Disposition of nonconforming product shall be documented (820.90(b)).

Records for rejected components should state whether the components were returned, scraped, reworked, etc. Most large manufacturers record disposition of rejected components on standard forms.

When components, materials, etc., become obsolete, many manufacturers assign new identification numbers to the new version of these components etc. The obsolete items are retained for other uses, such as repair parts, engineering projects, etc. In these cases the old and new items should be adequately segregated and/or identified to prevent inadvertent use of obsolete components in production.

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6: Deviations observed in overview, basic measure

Main Process

Main Process

Procedures SM 1 SQA 2 3 4 5 6 7 8 9

CON 141.00/03 x x CON 227.00/01 x x

PPS 2.4.1 x x

CFP 11-010 x

CFF 11-026 x

* * *

PPS 2.4.2 x

CFM 11-012 x

Qualification of supplier

Qualification of supplier

Procedures 3.1 type 3.2

purch

MM

spec. process CTS process NCA

SQA

IDS 121.22 X

CON 213.03/01 X

CFM 11-012 X X

IDS 129.06 X X

CFP 11-010 X

CFM 11-012

F3P-FN-265

IDS 129.05

PPS 243

Qualification of supplier Procedures 3.3 spec. process audit

report

VHF

IDS 121.22 X

CON 213.03/01 X CFM 11-012

IDS 129.06

CFP 11-010

CFM 11-012 X X X

F3P-FN-265 X

IDS 129.05 X

PPS 243 X

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Qualification of Supplier Item combination

Qualification of Supplier Item combination

Procedures 6.1 Eng. 6.2

spec. process CVP CVP process 6.3

PPS 242 X

CON 243.04/01

IDS 243.04

Qualification of Supplier Item combination Procedures eng. 6.4

process IR

6.5

PPS 242

CON 243.04/01 X

IDS 243.04 X

Monitoring of items

Monitoring of items

Procedures 7.2 7.1 RI

spec insp.protocol process

F3G00-14 X X X

CFM 11-012

Monitoring of items

Procedures 7.4 eng. 7.3 eng./sqa

reports decision F3G00-14

CFM 11-012 X X

Receiving Inspection

Receiving Inspection

Procedures RI A B D

Rec.

Ticket

process decision process

C

decision process

F3G00-14 X X X X X X X X GM35-002 X

IDS 243.04 PPS 2.4.2 CFM 11-012 CON 31.05/01

F3G05-54 F3A-FN135E

(18)

Procedures E F G1

CVP process insp.

Report

insp.

Protocol

process insp.

Report

F3G00-14 X

GM35-002

IDS 243.04 X

PPS 2.4.2 X X X

CFM 11-012 X X X

CON 131.05/01

F3G05-54

F3A-FN135E

Procedures G2 process insp.

Report

no RI H I MRR PET/SG J

F3G00-14 X X X X X

GM35-002

IDS 243.04

PPS 2.4.2 X X X X

CFM 11-012 X X

CON 131.05/01 X X X

F3G05-54 X X

F3A-FN135E X

Monitoring of suppliers

Monitoring of suppliers

Procedures 8.2 SQA 8.1

trigger auditplan process ass.report

CFM 11-012 X X X X

CFP 11-010 X X

IDS 341.02 X

IDS 243.03 X

IDS 243.02

Monitoring of suppliers

Procedures 8.4 SQA 8.3

trigger process SR

8.5 8.6

CFM 11-012 X X X

CFP 11-010 X

IDS 341.02

IDS 243.03

IDS 243.02

(19)

7A: Deviations observed in interpretation, basic measure Sheet A: Spreading in answers

Type artikel

Qualify (according to the procedure)

Qualifying depends on the product

Never Qualify (according to the procedure)

No

arrangements

are made Total Physical item

Slofjes voor de

cleanroom 10 1 1 12

Labels 7 6 13

Seal Mandrel 9 3 12

Zeep voor handen

wassen 5 4 3 12

Reinigings-middelen 5 7 12

Compound 9 1 10

Tafels op productie 7 1 1 3 12

Omdozen 5 2 3 10

Instruction for use 11 11

Software voor

afkeurregistratie 8 1 9

Etyleenoxyde 11 11

Sealtool 5 2 4 11

Handschoenen 9 2 11

Opslagdepot 7 1 8

Services Schoonmaken

cleanroom 8 2 10

Verhuur

bedrijfskleding 4 1 1 3 9

Transport gereed

product 10 10

Coaten van stents 6 3 9

Onderhoud

extrusiemachine 8 1 1 10

Calibratie van

meetapparatuur 8 2 10

Vertaalbureau’s 8 2 10

Kantine 4 3 3 10

Uitzendbureau 3 1 1 5 10

Detacherings-bureau 3 1 1 5 10

Consultation Uitbesteden

leveranciers-audit 8 1 9

Opleidings-instituut 2 4 1 3 10