820 Audit Checklist

7/28/2019 820 Audit Checklist

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Quality Systems Reg ChecklistPart 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 relevantstandards and regulations, such as design plan,

design input, design output, design review

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);

2.2 Do the Design Plans include significant

elements/tasks such as design reviews, clinicaltrials, risk analysis, verification & validation? Do

they define responsibilities, interfaces, and

timing? 21CFR 820.30(b)

2.3 Have the Design plans been approved, and

then updated and re-approved as the program

progresses? 21 CFR 820.30(b)

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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3.2 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 andregulatory requirements related to the

product? 21CFR 820.30(c); ISO 9001/13485

7.3.2

3.3 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

3.4 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

3.5 Do design Inputs include and output of

previous risk Management activities?

4.0 Design

Output

4.1 Have the Design Outputs essential for properfunctioning 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)

4.2 Do the Design Outputs contain or reference

acceptance criteria, as well as any other

appropriate information for purchasing,

production and servicing? 21CFR820.30(d)

4.3 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

5.0 Design

Review


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5.1 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

5.2 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)

5.3 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 Inputrequirements were satisfied? 21CFR820.30(f)

6.2 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)

6.3 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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6.4 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

7.3.56.5 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

6.6 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)

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 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

7.2 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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7.3 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

7.4 If external evaluations were required, do therecords 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)

7.5 Does Design Validation include risk analysis?

21CFR820.30(g)

7.6 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

7.7 Has labeling been defined, reviewed, and

approved to ensure compliance with design

input requirements? 21CFR 801

7.8 If the audited program contains software, is

there evidence that the software is validated

(such as specification, code reviews, moduletesting, validation, release, etc.)?

21CFR820.30(g)

7.9 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)

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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8.2 Has the manufacturing process been

verified/validated to meet the

specifications(Device Master Record) for the

audited project? 21CFR820.30(h

8.3 Has the installation process been

verified/validated to meet specified

requirements? 21CFR820.30(h)8.4 Have the service procedures been

verified/validated to meet specified

requirements? 21CFR820.30(h)

8.5 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 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)

9.2 Have all changed been validated, or where

appropriate verified, before implementation?

21CFR 820.30(i)

9.3 Were audited changes reviewed and approved

before implementation and are theydocumented according to the procedure?

21CFR 820.30(i)

9.4 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)

9.5 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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9.6 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

9.7 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

9.8 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?

10.0 DHF

10.1 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)

10.2 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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GF Health Products, Inc. objective evidence Pass / Fail


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820 Audit Checklist