Page 1 of 7

Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.1/ 4.2
820.5
820.20

4.3
820.160
4.4
820.30

Title/STS SOP

Look For

Quality System
QSD-402
QAM-1

1)

Contract Review
QSD-403

1)

Are there records that Contract

Review is being performed ?

Design Controls
QSD-404

1)

Check design history file for:

a)
Design input.
b)
Design output makes
reference to acceptance
requirements.
c)
Design outputs essential for
the proper identification are
identified.
d)
Approval of design output.
Design review is completed according
to schedule.
Design verification is documented
including:
- Methods
- Personnel
Design validation performed under
defined operating conditions.
Personnel and date of validation are
documented.
Is design correctly translated into
production specifications?

2)
3)
4)

2)
3)

4)
5)
6)

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Observations

Evidence that the quality policy is

understood by all personnel.
Is organizational chart accurate?
Management Review
Quality System procedures

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Page 2 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.5
820.40

4.6
820.50
4.7

Title/STS SOP

Look For

Document Control
QSD-405

1)
2)
3)

Purchasing Controls
QSD-406
PUR Series
REG-16
Control of Customer
Supplied Product

1)

2)
1)

Observations

Current revisions of SOP's and data

sheets are used.
SOP's are up-to-date.
Technicians are familiar with the SOPs
that affect quality.
Raw materials are purchased from an
approved vendor list.
Quality requirements are on
purchasing documents.
Procedures that show control of
verification, storage, and maintenance

of
2)

4.8
820.60
820.65

4.9
820.70

Identification
Traceability
QSD-408

1)

Production and
Process Controls
QSD-404
QSD-409
QSD-411

1)
2)

2)

3)
4)
5)
6)
7)
8)

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customer supplied product (CSP).

Evidence that CSP which is damaged
or is otherwise unsuitable for use is
recorded and reported to the customer.
All product (raw and test materials) are
properly labeled or quarantined.
Look to see if test numbers , personnel,
dates, Z #'s, are recorded on data
sheets.
Are all instructions are formal?
Revision #'s of controlled documents,
labels, and signs.
Are there procedures for all work
affecting quality?
Processes are performed to their
written procedures.
Housekeeping is scheduled, performed
and documented.
Correction factors are available
Check maintenance schedules
Validation of software processes.

QA-31:R-6

Page 3 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.9
820.170
4.9
820.75

Title/STS SOP

Look For

Installation/
QSD-409

1)
2)
3)

Process Validation
QSD-409

1)
2)
3)
4)

5)

If necessary, are there procedures for

installation.
Inspection of installation.
Installed by qualified personnel.
Are methods of processing and testing
validated.
Are there procedures defining
validations.
Are training records for people
performing validations up-to-date?
Does raw data from validation activities
document:
- date
- personnel
- major equipment
- control method
If changes have been made to the
equipment and process, has a
determination been made on
revalidations?

4.10
820.80
820.86

Receiving, In-Process
and Finished Device
Acceptance
QSD-410

1)
2)

Are receiving logs up-to-date?

Raw materials reflect acceptance
status.

4.11

Inspection, Measuring,
and Test Equipment
QSD-411

1)
2)

Is the status of all M & TE identified?

Are M & TE stored to prevent
invalidation of calibration.
All measurements and specifications
have tolerances where necessary.
Is equipment being using within its
limitations.

820.72

3)
4)

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Observations

QA-31:R-6

Page 4 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.12
820.120

Title/STS SOP

Look For

Device Labeling
QSD-412
LRP-15

1)
2)

3)

4)
5)
6)
4.13
820.90
4.14
820.100

Non-Conforming
Product (NCP)
QSD-413

1)

Corrective and
Preventive Action
QSD-414
REG-14

1)

2)

Observations

Are all labels controlled?

Look for information labels.
Are all labels controlled properly?:
- locked up
- identified in a procedure
- control #s
Is everything that should have labels,
labeled?
Is FIFO practiced?
Are off-test products returned to the login area?
Is rejected product properly labeled,
and or quarantined?
Has NCP been properly evaluated?

Check log sheets to ensure out of

specification (OOS) temperatures have
a CAR.
2)
Check CAR log to see if the department
has any CAR's that are not resolved.
3) Check corrective actions for effectiveness.

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QA-31:R-6

Page 5 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.15
820.130
820.140
820.150
820.160

Title/STS SOP

Look For

Device Packaging,
Handling, and Storage
Distribution
QSD-415

1)
2)
3)
4)

4.16
4.2.2

Device Master Record

(DMR)

1)

4.16
820.184

4.16
820.180

Are sterile items stored to prevent

contamination?
Is media that is supposed to be stored
in the dark, stored properly.
Are accepted raw materials and test
articles kept separate from product that
has not been accepted?
Look for documentation demonstrating
customer's original requirements were
met.

3)
4)

Are device specifications included in

the DMR?
Are all SOP's for production in the
DMR.
Are inspections, labels, tags identified?
Specifications for labeling.

DHR Device History

Record
QSD-416

1)
2)
3)
4)
5)

Can you find the dates of processing.

How many were completed.
How many were released.
Acceptance and rejection records.
Labeling identification.

Records
QSD-416

1)
2)
3)

Are records stored properly?

Is restricted access practiced?
Check log books, notebooks, folders
and data sheets for proper
documentation practices (cross-outs,
writeovers, white-out, etc.)

2)

820.181

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Observations

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Page 6 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:

QSR/ISO/EN
Section
4.17
820.22
4.18
820.25
4.20
820.200

Title/STS SOP

Look For

Quality Audit
QSD-417

1)

Completion of corrective action from

previous audit.

Personnel
QSD-418
SRP-11

1)
2)

Completeness of training records.

Anyone who needs a CV, has one.

Statistical
Techniques
QSD-420

1)

Are there any requirements for

statistical techniques?
Statistical techniques can be found in:
customer specifications
SOPs
Reference Standards
Acceptance Criteria
(i.e. sampling plans)

2)

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Observations

QA-31:R-6

Page 7 of 7
Department Audited:

Auditors:

Escort:

Audit Dates:
SOPs Audited

Comments

Internal Auditor Notes and Comments

Audited to:
QSR = Quality System Regulation, Part 820, CFR21
ISO = ISO 9001
EN = EN 46001

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QA-31:R-6