Page 1 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Quality System QSD-402 QAM-1 1) 2) 3) 4) 1)

Look For Evidence that the quality policy is understood by all personnel. Is organizational chart accurate? Management Review Quality System procedures Are there records that Contract Review is being performed?

Observations

820.5 820.20

820.160

Contract Review QSD-403

820.30

Design Controls QSD-404

1)

2) 3)

4) 5) 6)

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?

21 CFR 820 Audit Checklist

Page 2 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Document Control QSD-405

Look For 1) 2) 3) 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 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.

Observations

820.40

820.50

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

1)

2)
1)

2)

820.60 820.65

Identification Traceability QSD-408

1) 2)

820.70

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

1) 2) 3) 4) 5) 6) 7) 8)

21 CFR 820 Audit Checklist

Page 3 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Installation/ QSD-409

Look For 1) 2) 3) 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? Are receiving logs up-to-date? Raw materials reflect acceptance status.

Observations

820.170

820.75

Process Validation QSD-409

1) 2) 3) 4)

5)

820.80 820.86

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

1) 2)

820.72

Inspection, Measuring, and Test Equipment QSD-411

1) 2) 3) 4)

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.

21 CFR 820 Audit Checklist

Page 4 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Device Labeling QSD-412 LRP-15

Look For 1) 2) 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. Check CAR log to see if the department has any CAR's that are not resolved. Check corrective actions for effectiveness.

Observations

820.120

3)

4) 5) 6) Non-Conforming Product (NCP) QSD-413 Corrective and Preventive Action QSD-414 REG-14 1) 2) 1) 2) 3)

820.90

820.100

21 CFR 820 Audit Checklist

Page 5 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Device Packaging, Handling, and Storage Distribution QSD-415

Look For 1) 2) 3) 4) 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. Are device specifications included in the DMR? Are all SOP's for production in the DMR. Are inspections, labels, tags identified? Specifications for labeling. Can you find the dates of processing? How many were completed. How many were released. Acceptance and rejection records. Labeling identification. 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.)

Observations

820.130 820.140 820.150 820.160

Device Master Record (DMR) 820.181

1) 2) 3) 4)

820.184

DHR Device History Record QSD-416

1) 2) 3) 4) 5) 1) 2) 3)

820.180

Records QSD-416

21 CFR 820 Audit Checklist

Page 6 of 11 Department Audited: Escort: Auditors: Audit Dates:

QSR/ISO/EN Section

Title/STS SOP Quality Audit QSD-417 Personnel QSD-418 SRP-11 Statistical Techniques QSD-420

Look For 1) Completion of corrective action from previous audit. Completeness of training records. Anyone who needs a CV, has one. Are there any requirements for statistical techniques? Statistical techniques can be found in: customer specifications SOPs Reference Standards Acceptance Criteria (i.e. sampling plans)

Observations

820.22

820.25

1) 2) 1) 2)

820.200

21 CFR 820 Audit Checklist

Page 7 of 11 Department Audited: Escort: Auditors: Audit Dates:

SOPs Audited

Comments

Internal Auditor Notes and Comments Audited to: QSR = Quality System Regulation, Part 820, CFR21

21 CFR 820 Audit Checklist

Page 8 of 11 Department Audited: Escort: Auditors: Audit Dates:

Required Procedures

21 CFR Section

Check

Procedures for MDRs A documented quality program Documentation of Management review of quality system at defined intervals and at sufficient frequency Procedures for audits Records of audits Procedures for identifying training needs Documentation of any necessary personnel training programs Documents relating to design controls including the Design History File Procedures for specification control measures to assure that device, components , and packaging design results in approved specifications Document controls not previously mentioned Document of specification changes Procedure of approval of change of manufacturing process Record of percentage of defective components for each lot and the percentage of lots rejected Purchasing controls not previously mentioned Limitations or allowable tolerances on equipment Records of equipment inspections Procedures and specifications for manufacturing processes

803.17 820.20 820.20 820.22 820.22 820.25 820.25 820.30 820.40

820.40 820.40 820.40 820.50 820.50 820.70 820.70 820.70

21 CFR 820 Audit Checklist

Page 9 of 11 Department Audited: Escort: Auditors: Audit Dates:

Records of maintenance activities Procedures for processing control Documentation of inspections of any required environmental control system Procedures for contamination control Procedures and schedules for maintenance, adjustment, and cleaning of equipment Procedures for use and removal of manufacturing material Record of removal of manufacturing material Procedure for approval of changes to software programs Procedures for acceptance of components Records of acceptance or rejection of components Procedures for finished device inspection and sampling plans Documentation of testing of computer software programs for calibrating, inspecting, and checking measurement equipment Procedures for calibration, inspection, and checking of measurement equipment Procedures and limits for accuracy and precision in calibration of measurement equipment Records documenting traceability of calibration standards Records of calibration, inspection, and checking of measurement equipment Records of calibration of measurement equipment Procedures for reprocessing of devices or components Record (implied) of final inspection of reprocessed device

820.70 820.70 820.70 820.70 820.70 820.70 820.70 820.70 820.80 820.80 820.80 820.84 820.84 820.84 820.84 820.84 820.84 820.90 820.90

21 CFR 820 Audit Checklist

Page 10 of 11 Department Audited: Escort: Auditors: Audit Dates:

Records of the disposition of obsolete, rejected, or deteriorated components Records of investigation of failure of device or components after release for distribution Procedures for warehouse control and distribution of finished devices Where necessary, system to assure that oldest approved devices are distributed first Record of examination of labeling materials Device Master Record Device History Record Record of critical operations in device history records by responsible individual Records of written and oral complaints Record of complaint investigation or reason no investigation was done Complaints pertaining to injury, death, or any hazard to safety Servicing procedures, records, and record evaluations Statistical techniques: identification of valid techniques, sampling plans, adequacy

820.90 820.100 820.124

820.162 820.181 820.184 820.184 820.198 820.198 820.198 820.200 820.250

21 CFR 820 Audit Checklist

Page 11 of 11 Department Audited: Escort: Auditors: Audit Dates:

Upper Confidence Level 0 out of: A B C D E F 30% 25% 20% 15% 10% 5% 11 13 17 23 35 72 1 out of: 17 20 26 35 52 115 2 out of: 22 27 34 46 72 157

21 CFR 820 Audit Checklist