Quality Systems Reg Checklist

Part 3 - Design Controls 1.0 General 1.1 Is there a documented and implemented Design Control procedure(s) for the development of product and services? Does the procedure cover all clauses in relevant standards and regulations, such as design plan, design input, design output, design review verification and validation, design transfer, and 1.2 Are programs being run under Phase Review Discipline or an equivalent framework? Does the documentation show compliance to the overall process, completion of application check list items, and the proper approval signatures? (No reference) 1.3 Have all known open issues undergone an evaluation/justification prior to approval to proceed to the next development checkpoint or milestone? (No reference)

2.0 Design Planning 2.1

Are the Design Plans documented, current and under revision control? 21CFR 820.30(b); Do the Design Plans include significant elements/tasks such as design reviews, clinical trials, risk analysis, verification & validation? Do they define responsibilities, interfaces, and timing? 21CFR 820.30(b) Have the Design plans been approved, and then updated and re-approved as the program progresses? 21 CFR 820.30(b)

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3.0 Design Input 3.1

Are the Design Input requirements documented, under revision control, reviewed, and approved? Are they clearly explained, complete, unambiguous, and maintained up to date? 21CFR 820.30 ISO 9001/13485 7.3.1

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Do the Design Inputs contain? Functional, performance, labeling, and safety requirements; information derived from similar designs; other requirements essential for design and development; and do they address the user needs and intended uses of the device? Do they contain statutory and regulatory requirements related to the product? 21CFR 820.30(c); ISO 9001/13485 7.3.2 Is there a procedure to resolve incomplete, conflicting or ambiguous requirements between documents (e.g. product data sheet vs. SDRS vs. production test requirements)? 21CFR 820.30; ISO 9001/13485 7.3.2 Does the Design input address any required performance or safety standards, such as: Rad Health regulations 21CFR Parts 1020 or 1030; Canadian Medical Device requirements; essential requirements of EU MDD Annex 1; etc.? 21CFR 820.30 Do design Inputs include and output of previous risk Management activities?

3.4

3.5 4.0 Design Output 4.1

Have the Design Outputs essential for proper functioning been identified in a Manufacturing test specification or equivalent document? Do they follow a revision controlled process, and do they include acceptance criteria? 21CFR820.30(d) Do the Design Outputs contain or reference acceptance criteria, as well as any other appropriate information for purchasing, production and servicing? 21CFR820.30(d) Have the Design Outputs been approved, and does the documentation include the date and signature of the people approving the output? 21CFR820.30(d); ISO 9001/3485 7.3.3

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5.0 Design Review

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Is there documented and implemented procedure that defines minimum requirements for formal Design Reviews, including planning of reviews, required participants, identification of follow-up actions, and the required records documentation? 21CFR820.30 Have formal Design Reviews been performed per the Design Plan and design procedures? Do the Design Review participants include all key interface functions, any specialists required, and an independent reviewerand are these roles identified in the notes or minutes of the meeting? 21CFR820.30(e)

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Do the Design Review meeting notes or minutes contain the date of the review, identification of the design that was reviewed, and action items: Have the actions been completed/implemented? 21CFR820.30(e); ISO 9001/13485 7.3.4

6.0 Design Verification 6.1

Were the Design Verification activities performed in accordance with the Design Plan and Verification Plan, and do the verification records confirm that all Design Input requirements were satisfied? 21CFR820.30(f) Were all verification protocols, procedures and acceptance criteria reviewed and approved before execution? Have all verification results and reports been completed, reviewed and approved? 21CFR820.30(f) Does the Verification documentation include identification of what was tested, including configuration, and what test equipment was used, including serial numbers or equivalent? 21CFR820.30(f)

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Are the engineering issues or concerns (including those found during verification or validation) recorded in a defect data collection system? Is there evidence that all verification failures or negative results have been addressed? 21CFR820.30(f); ISO 9001/13485 7.3.5 When claims of conformance to standards are made, is there documented and sound rationale for any situations where partial compliance or other deviations from these standards have been identified? 21CFR820.30(f); ISO 9001/13485 7.3.2 Are the claims contained in product labeling and promotional literature regarding product specifications, performance, and safety, supported by design verification or validation evidence? If there have been any subsequent product specification changes which could affect the labeling, have the changes been verified and/or validated? 21CFR820.30(f)

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6.7

Are all verification and Validation activities and Design outputs directly traceable to Design Inputs and vice versa? 21CFR820.30

7.0 Design Validation 7.1

7.2

Were the Validation activities performed in accordance with the Design Plan and the Validation Plan, and have they demonstrated that user needs and intended uses were satisfied? 21CFR820.30(g); ISO 9001/13485 7.3.6 Is there a documented decision regarding the need for external evaluation or clinical studies, and, if needed, were the evaluation protocols documented in an approved plan prior to their execution? 21CFR820.30(g); ISO 9001/13485 7.3.6

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Was Design Validation performed using production equivalent products/units, and was the complete configuration of the system recorded in the validation records? 21CFR820.30(g)l USI 9001/13485 7.3.6 If external evaluations were required, do the records indicate that the plan was fully executed prior to the delivery or release of the product and that the intended uses have been satisfied, including resolution of any discrepancies? 21CFR820.30(g) Does Design Validation include risk analysis? 21CFR820.30(g) Is there evidence that the packaging design has been specified and validated to protect the device from alteration or damage during processing, storage, handling and distribution? Are the validation results recorded? 21CFR820.30(g); 820.130 Has labeling been defined, reviewed, and approved to ensure compliance with design input requirements? 21CFR 801 If the audited program contains software, is there evidence that the software is validated (such as specification, code reviews, module testing, validation, release, etc.)? 21CFR820.30(g) If software tools (such as third-party design software, compilers, simulators, debuggers, etc.) are used during development activities, is there evidence that those tools have been validated for such use? 21CFR820.70(i)

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8.0 Design Transfer 8.1

Is there a reviewed and approved manufacturing plan or equivalent that details the activities required for Design transfer? Is there evidence the required activities have been completed? 21CFR820.30(h)

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Has the manufacturing process been verified/validated to meet the specifications(Device Master Record) for the audited project? 21CFR820.30(h Has the installation process been verified/validated to meet specified requirements? 21CFR820.30(h) Have the service procedures been verified/validated to meet specified requirements? 21CFR820.30(h) Have the manufacturing procedures/work instructions been approved and implemented, and are they under change control? 21CFR820.30(h)

9.0 Design Change 9.1

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9.4

Is there a documented and implemented procedure controlling & defining Design Change control throughout the product life cycle, including pre production? Is there evidence that the procedure is followed? 21CFR 820.30(i) Have all changed been validated, or where appropriate verified, before implementation? 21CFR 820.30(i) Were audited changes reviewed and approved before implementation and are they documented according to the procedure? 21CFR 820.30(i) When Design Changes that affect Design Input or Design Output are made, does the change control process require that a decision be made regarding the extent of design control activities that will be required? (for example, does risk assessment, V&V, etc., need to be repeated?) Where these activites executed for the changes that were audited? 21CFR 820.30(i) Do the audited Design Changes include an evaluation of the effect of changes on the constituent parts and product already delivered? 21CFR 820.30(i);

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If the product is an FDA class 2 device, were all changes to the product (or its intended use) analyzed to determine if a new 510(k) was required? Was each determination documented, and was it performed per FDA guidance? 21CFR 807.81 If the product is a PMA device, were all changes analyzed to determine whether a PMA supplement was necessary? Was each determination documented, and was it performed per FDA guidance? Were all proper communications made to FDA within required time limits? 21CFR 814.69 Have all design changes been correctly evaluated for possible impact on the Canadian Device License, the CE Mark and Declaration or Conformity, and the Technical File or Technical Dossier? Is the DHF complete and up-to-date for the audited design project? Does the DHF comply with the procedural requirements, and does it contain all required documentation and records, including original test data? 21CFR 820.30(j) For products distributed in Europe, is there a Technical file or Design Dossier that demonstrates that all CE marking essential requirements have been met, and is there a Declaration of Conformity on file? 93/42/EEC

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10.0 DHF 10.1

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GF Health Products, Inc. objective evidence

Pass / Fail