Documents, Records and Change Control

Transcription

1 Documents, Records and Change Control Lori S. Lawless Medical Device Specialist Food and Drug Administration Baltimore District Office (410) May 13-14, 2008 Baltimore 1

2 Introduction Purpose of the Subsystem Document controls 21 CFR Records/General requirements 21 CFR Definitions 21 CFR Device master record 21 CFR Device history record 21 CFR Quality system record 21 CFR Traceability 21 CFR May 13-14, 2008 Baltimore 2

3 Documents, Records and Change Control Subsystem Purpose - to assure: 1. Specifications and procedures are adequate 2. Only current documents are used 3. Changes are reviewed, approved and incorporated into documents 4. Documents are maintained for the required length of time May 13-14, 2008 Baltimore 3

4 Document Controls General Requirements 21 CFR May 13-14, 2008 Baltimore 4

5 Document Controls Establish and maintain procedures to control all documents required by Part 820 Procedures shall provide for: 1. Document approval and distribution 2. Document changes 21 CFR May 13-14, 2008 Baltimore 5

6 Document Approval Designate an individual(s) to review documents for adequacy and approve them prior to issuance Document approval including date and signature of approving individual(s) 21 CFR (a) May 13-14, 2008 Baltimore 6

7 The Preamble on Electronic Signatures the quality system regulation s use of the term signature will permit the use of whatever electronic means the agency determines is the equivalent of a handwritten signature. Preamble, Comment 94 [Refer to Part 11 and associated guidance.] May 13-14, 2008 Baltimore 7

8 The Preamble on Stamps stamps could be acceptable if the manufacturer has a formal procedures on how stamps are used in place of handwritten signatures. The procedure would have to address how the stamps would be controlled and how the manufacturer would ensure that the stamp was in fact the user s signature. Preamble, Comment 94 May 13-14, 2008 Baltimore 8

9 Document Distribution Documents required by Part 820 shall be available at all locations for which they are designated, used, or otherwise necessary. Remove all obsolete documents promptly or otherwise prevent their unintended use 21 CFR (a) May 13-14, 2008 Baltimore 9

10 Document Changes Have changes to documents reviewed and approved by individual(s) from same function or organization that performed original review and approval Communicate changes to appropriate personnel in a timely manner 21 CFR (b) May 13-14, 2008 Baltimore 10

11 The Preamble on Review of Changes The intent of the requirement is to ensure that those who originally approved the document have an opportunity to review any changes because those individuals typically have the best insight on the impact of the changes. The requirement permits the manufacturer to specifically designate individuals who did not perform the original review and approval to review and approve the changes. Preamble, Comment 96 May 13-14, 2008 Baltimore 11

12 The Preamble on Communicating Changes to Personnel FDA has had many experiences where manufacturers made corrections to documents, but the changes were not communicated in a timely manner to the personnel utilizing the documents. The result of these untimely communications was the production of defective devices. Preamble, Comment 96 May 13-14, 2008 Baltimore 12

13 Document Changes Include in change records: 1. Description of change 2. Identification of affected documents 3. Signature of approving individual(s) 4. Approval date 5. When change becomes effective 21 CFR (b) May 13-14, 2008 Baltimore 13

14 Records General Requirements 21 CFR May 13-14, 2008 Baltimore 14

15 Records General Requirements Maintain all records required by Part 820 at manufacturing site or location that is reasonably accessible to manufacturer and FDA Make required records readily available for review and copying 21 CFR May 13-14, 2008 Baltimore 15

16 The Preamble on readily available records FDA expects that such records will be made available during the course of an inspection. If the foreign manufacturer maintains records at remote locations, such records would be expected to be produced by the next working day or 2, at the latest. The FDA has clarified that records can be kept at other than the inspected establishment, provided that they are made readily available for review and copying. Preamble, Comment 180 May 13-14, 2008 Baltimore 16

17 Records General Requirements Records shall be legible Store records in a way that will minimize deterioration and prevent loss Back up records stored in an automated data processing system 21 CFR May 13-14, 2008 Baltimore 17

18 Confidentiality Confidentiality During an inspection manufacturer may mark records deemed confidential to assist FDA in determining whether information may be disclosed under FOI 21 CFR (a) May 13-14, 2008 Baltimore 18

19 Record Retention Period Retain all records required by Part 820 for the expected life of the device or at least 2 years from the date of release for commercial distribution -- if the device is short-lived 21 CFR (b) May 13-14, 2008 Baltimore 19

20 The Preamble on retention of records FDA believes that all records should be retained for a period equivalent to the design and expected life of the device, but in no case less than 2 years, whether the records specifically pertain to a particular device or not FDA believes manufacturers need all such records when performing any type of investigation. Preamble, Comment 181 May 13-14, 2008 Baltimore 20

21 Exceptions Manufacturers are not required to make the following types of records available for review and copying by FDA: 1. Management review reports 2. Quality audit reports 3. Evaluations of suppliers, contractors and consultants 21 CFR (c) May 13-14, 2008 Baltimore 21

22 Exceptions During FDA inspections manufacturers must make available for review procedures for conducting: management reviews quality audits evaluations of suppliers, contractors and consultants 21 CFR (c) May 13-14, 2008 Baltimore 22

23 Device Master Record (DMR) 21 CFR May 13-14, 2008 Baltimore 23

24 Definition Device Master Record Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. 21 CFR 820.3(j) May 13-14, 2008 Baltimore 24

25 Device Master Record Maintain device master record (DMR) Prepare and approve DMR in accordance with 21 CFR CFR May 13-14, 2008 Baltimore 25

26 Device Master Record Include in the DMR: 1. Device specifications 2. Production process specifications 3. Quality assurance procedures and specifications 4. Packaging and labeling specifications 5. Installation, maintenance and servicing procedures and methods 21 CFR May 13-14, 2008 Baltimore 26

27 Device Master Record Device specifications Drawings fabrication, assembly, subassembly Composition Formulation Component specifications Software specifications List of ingredients Bill of materials Certificate of compliance requirements Wiring and piping schematics May 13-14, 2008 Baltimore 27

29 Device Master Record Production process specifications Equipment specifications Production methods Production procedures Production environment specifications Vessels, mixers, tools, molds Cleaning procedures Blending or mixing procedures Process or assembly lines Machine maintenance procedures Calibration procedures Setup procedures Process flow charts May 13-14, 2008 Baltimore 29

31 Device Master Record Quality assurance procedures and specifications Acceptance criteria Quality assurance equipment Inspection/test procedures Pretest conditions Approved deviations Blank job travelers Blank inspection/test forms Instrument charts Reporting forms Process control charts Blank DHR forms May 13-14, 2008 Baltimore 31

33 Device Master Record Packaging and labeling specifications Packaging and labeling specifications Label/labeling drawings Label/labeling review procedures and forms Service manual Package drawings Packaging and labeling control procedures Customer feedback forms Packing procedures Special shipment procedures May 13-14, 2008 Baltimore 33

35 Device Master Record Installation, maintenance and servicing procedures and methods Installation procedures Service procedures Drawings Tools, testers, instruments Blank test/inspection forms Inspection/test criteria and procedures Calibration procedures and equipment Calibration standards May 13-14, 2008 Baltimore 35

36 Device Master Record Miscellaneous Storage conditions, requirements Control procedures and activities Final release procedures Release document review list Distribution procedures Blank DHR forms Hazards, safety precautions May 13-14, 2008 Baltimore 36

37 Device History Record (DHR) 21 CFR May 13-14, 2008 Baltimore 37

38 Definition Device History Record Device history record (DHR) means a compilation of records containing the production history of a finished device. 21 CFR 820.3(i) May 13-14, 2008 Baltimore 38

39 Device History Record Maintain device history record (DHR) to demonstrate that the device is manufactured in accordance with the DMR and Part 820 Establish and maintain procedures for the DHR 21 CFR May 13-14, 2008 Baltimore 39

40 Device History Record DHR shall include: 1. Dates of manufacture 2. Quantity manufactured 3. Quantity released for distribution 4. Acceptance records which demonstrate the device is manufactured in accordance with DMR 21 CFR May 13-14, 2008 Baltimore 40

41 Device Labeling Document in the DHR: The release of labeling and the date and signature of the person examining the labeling The label and labeling used for each production unit, lot or batch 21 CFR (b) & (c) May 13-14, 2008 Baltimore 41

42 The Preamble on Automated Readers for Labeling Inspections several recalls on labeling have been attributed to automated readers not catching errors. The requirement does not preclude manufacturers from using automated readers where that process is followed by human oversight. A designated individual must examine, at a minimum, a representative sampling of all labels that have been checked by the automated readers. Preamble, Comments 169 May 13-14, 2008 Baltimore 42

43 The Preamble on Automated Readers for Labeling Inspections automated readers are often programmed with only the base label and do not check specifics, such as control numbers and expiration dates, among other things, that are distinct for each label. Preamble, Comments 169 May 13-14, 2008 Baltimore 43

44 Quality System Record (QSR) 21 CFR May 13-14, 2008 Baltimore 44

45 Definition Quality system record (QSR) means????? May 13-14, 2008 Baltimore 45

46 Quality System Record Maintain Quality System Record (QSR) Prepare and approve per 21 CFR Include or refer to location of: Procedures and documentation of activities required by Part 820 that are not specific to a particular type of device Records required by 21 CFR CFR May 13-14, 2008 Baltimore 46

47 Traceability Traceability requirements apply to devices intended: For surgical implant into the body To support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in labeling can reasonably be expected to result in significant injury to the user 21 CFR May 13-14, 2008 Baltimore 47

48 Traceability Establish and maintain procedures for identifying with a control number each unit, lot or batch of finished devices and, where appropriate, components Document identification in DHR Purpose: to facilitate corrective action 21 CFR May 13-14, 2008 Baltimore 48

49 The Preamble on Component Traceability the manufacturer should perform risk analysis first on the finished device, and subsequently on the components of such device, to determine the need for traceability the extent of traceability for both active and inactive implantable devices should include all components and materials used when such products could cause the medical device not to satisfy its specified requirements. Preamble, Comment 121 May 13-14, 2008 Baltimore 49

50 Definition Lot or Batch Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits 21 CFR May 13-14, 2008 Baltimore 50

51 Summary Purpose of the Subsystem Document controls Records/General requirements Definitions Device master record Device history record Quality system record Identification & traceability May 13-14, 2008 Baltimore 51