OMTEC Design Controls -----Design Review CFR, Part ISO 13485:2003, Section 7.3. MidWest Process Innovation, LLC

Transcription

1 OMTEC 2013 MidWest Process Innovation, LLC Design Controls -----Design Review CFR, Part ISO 13485:2003, Section 7.3 Copyright, 2013, MPI, LLC 1

2 Design Review The Basic Requirements Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. To meet the systematic design review requirement, device design and design reviews should progress through defined and planned phases starting with the design input phase and continuing through validation of initial production units or lots. Subsequent activities are usually design changes. When the design process is a redesign of an existing device, a special effort should be made to assure that data obtained from previous failures, complaints, and service records are made available and reviewed by those responsible for design, design input and design review. Quality Data Copyright, 2013, MPI, LLC 2

3 Design Controls Begin Design Controls Design History File Device Master Record Risk Analysis Begins Verification Design Validation Inputs Inputs Transfer Device History Record Inputs Concept & Feasibility Design Review Design Design Review Pilot Design Review Mfring. Phase Product And Process Release Manufacturing Scale-up Planning Outputs Outputs Outputs Sales and Distribution Design Changes Begin Design History File Product History Quality Review Board Copyright, 2013, MPI, LLC 3

4 Scope..Impact on Device Life Cycle.. The QS regulation is in Part 820 of Title 21 of the Code of Federal Regulations (CFR). This regulation covers (at least these linked processes): quality management and organization auditing training device design acceptance activities purchasing controls / acceptance activities production and process controls and ancillary processes, packaging and labeling control, device evaluation, handling, storage, distribution, corrective action and preventive action non-conforming product complaint handling, servicing and installation document control and records statistical techniques Copyright, 2013, MPI, LLC 4

5 Design Review Formal Meeting Copyright, 2013, MPI, LLC 5

6 Formal Meetings..Periodic..Planned..Agenda There are four requirements related to design reviews: 1. The meetings should be formal. That is, key attendees are designated and the meetings are conducted at least once per stage/phase, are planned, are announced or are periodic, have an appropriate agenda, notes are recorded, etc., according to the manufacturer procedure for design reviews. Copyright, 2013, MPI, LLC 6

7 Discussion The term "review" is commonly used by manufacturers to describe a variety of design assessment activities. Most, but not all, of these activities meet the definition of formal design reviews. The following exceptions may help to clarify the distinguishing characteristics of design reviews. Developers may conduct routine or ad hoc meetings to discuss an issue, coordinate activities, or assess development progress. Decisions from such meetings may not require formal documentation; however, if a significant issue is resolved, this should be documented. If the outcome results in change to an approved design document, then applicable change control procedures should be followed. Copyright, 2013, MPI, LLC 7

8 Knowledgeable Personnel..Objective..Unbiased 2. To meet the definition of design review in 820.3(h), the review should include persons who are intimately knowledgeable about the technical characteristics of the design such as performance, safety, compatibility, etc. In many manufacturers this can only be done by those persons responsible for the design. However, reviews are to be objective, unbiased examinations by appropriately trained personnel which should include an individual(s) not responsible for the design. The moderator of the review meeting may be one of the persons not responsible for the design. Copyright, 2013, MPI, LLC 8

9 Pre and Post Design Review(s) 3. Pre- and post-review meeting significant responsibilities and assignments should be documented [820.30(b)]. These assignments are not unusual -- they are simply ordinary work required to develop a new product or modify an existing product. The progress and/or results of such assignments would typically be reported at the next review meeting. Documentation is not required for detailed day-to-day development activities that are part of the designers routine job. Copyright, 2013, MPI, LLC 9

10 DHF..Minutes..Plans were followed..or not 4. The design review meeting results are made a part of the device design history file. The results should include minutes and should include notes, or annotated draft drawings and annotated draft procedures that played a significant role during the design review. Such documents help show that plans were followed, verification/validation was reviewed, and, to some extent, how the design evolved. Copyright, 2013, MPI, LLC 10

11 Design Review The Pre-Amble Copyright, 2013, MPI, LLC 11

12 Design Review The Preamble One small manufacturer commented that the problems that Sec (e), ``Design review,'' is meant to reveal involve coordination, cooperation, or communication difficulties among the members of an organization and that these difficulties do not exist in a small company. Therefore, the comment stated that the design review requirements should not apply to small manufacturers. The purpose of conducting design reviews during the design phase is to ensure that the design satisfies the design input requirements for the intended use of the device and the needs of the user. Design review can include: - the input requirements review - the review of design verification data to determine whether the design outputs meet functional and operational requirements - the design is compatible with components and other accessories - the safety requirements are achieved - the reliability and maintenance requirements are met - the labeling and other regulatory requirements are met, and - the manufacturing, installation, and servicing requirements are compatible with the design specifications. Design reviews should be conducted at major decision points during the design phase Copyright, 2013, MPI, LLC 12

13 Design Review The Preamble..For a large manufacturer, design review provides an opportunity for all those who may have an impact on the quality of the device to provide input, including manufacturing, quality assurance, purchasing, sales, and servicing divisions. While small manufacturers may not have the broad range of disciplines found in a large company, and the need to coordinate and control technical interfaces may be lessened, the principles of design review still apply. The requirements under Sec (e) allow small manufacturers to tailor a design review that is appropriate to their individual needs. Copyright, 2013, MPI, LLC 13

14 The Pre-amble Design Review FDA also amended the requirements so that the results of a design review include identification of the design, the date, and the individual(s) performing the review. Thus, multiple reviews can occur and the manufacturer must document what is being reviewed, when, and by whom. FDA never intended to mandate that an individual without design responsibility conduct the design reviews and, to clarify its position, has rewritten the requirement. The requirement now states that the procedures shall ensure that each design review includes an individual(s) who does not have direct responsibility for the design stage being reviewed. This requirement will provide an ``objective view'' from someone not working directly on that particular part of the design project, to ensure that the requirements are met. In making this change, FDA also notes that it was not FDA's intention to prohibit those directly responsible for the design from participating in the design review. Copyright, 2013, MPI, LLC 14

15 The Nature of Design Review During the initial stages, issues related to design input requirements will predominate. Next, the main function of the reviews may be to evaluate or confirm the choice of solutions being offered by the design team. Then, issues such as the choice of materials and the methods of manufacture become more important. During the final stages, issues related to the verification, validation, and production may predominate. Copyright, 2013, MPI, LLC 15

16 Preamble - Design Review Initial Design Changes Manufacturers are not expected to maintain records of all changes proposed during the very early stages of the design process. However, all design changes made after the design review that approves the initial design inputs for incorporation into the design, and those changes made to correct design deficiencies once the design has been released to production, must be documented. The records of these changes create a history of the evolution of the design, which can be invaluable for failure investigation and for facilitating the design of future similar products. Such records can prevent the repetition of errors and the development of unsafe or ineffective designs. The evaluation and documentation should be in direct proportion to the significance of the change. Copyright, 2013, MPI, LLC 16

17 S/E..progressing to..manufacturability Thus, the reviews of the design input and the design should extend beyond merely satisfying user-stated requirements in order to assure that safety and effectiveness goals are met. As the development process progresses, the reviews should cover producibility and production documentation such as assembly drawings, manufacturing instructions, test specifications, test procedures, etc. Copyright, 2013, MPI, LLC 17

18 Design Review Part of the Plan Stage Gates, for example.. Copyright, 2013, MPI, LLC 18

19 Design Plans and Planning..basically, a plan The design planning exercise and execution of the plans are complex because of the many areas and activities that should be covered. Some of the key activities can be: determining and meeting the user/patients requirements; meeting regulations and standards; developing specifications for the device; developing, selecting and evaluating components and suppliers; developing and approving labels and user instructions; developing packaging; design reviews; developing specifications for manufacturing processes; verifying safety and performance of prototype and final devices; verifying compatibility with the environment and other devices; developing manufacturing facilities and utilities; developing and validating manufacturing processes; training employees; documenting the details of the device design and processes if applicable, developing a service program. Copyright, 2013, MPI, LLC 19

20 Design Reviews in the Design Plan Control of the design review process is achieved by developing and implementing a formal design review program consistent with quality system requirements. The following issues should be addressed and documented in the design and development plan(s). Number and Type of Reviews Selection of Reviewers Design Review Procedures (Logistics) Relationship of Design Review to Verification and Validation..In practice, design review, verification, and validation overlap one another, and the relationship among them may be confusing. As a general rule, the sequence is: verification, review, validation, review. Copyright, 2013, MPI, LLC 20

21 Design Reviews..Stage Gates..Close one door & open another The design reviews are conducted at strategic points in the design process Stage Gates. For example, a review is conducted to assure that the design input requirements are adequate before they are converted into the design specifications called design?. Another is used to assure that the device design is adequate before prototypes are produced for simulated use testing and clinical evaluation. Another, a validation review, is conducted prior to transfer of the design to production. Generally, they are used to provide assurance that an activity or phase has been completed in an acceptable manner, and that the next activity or phase can begin. Copyright, 2013, MPI, LLC 21

22 Design Review Occurs Throughout the Design Effort User Needs Design Review (e) Design Input (c) Design Process Design Verification (f) Design Output (d) Design Validation (g) Medical Device Copyright, 2013, MPI, LLC 22

23 Stage-gate..Cross-functional thinking..third party Design review [820.30(e)] is one of the key design control elements in a quality system. The objectives of design review are stated in the definition of design review in 820.3(h) as follows: Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. Copyright, 2013, MPI, LLC 23

24 Design Reviews..Formalized..Planned..Changes To meet the systematic design review requirement, device design and design reviews should progress through defined and planned phases starting with the design input phase and continuing through validation of initial production units or lots. Subsequent activities are usually design changes. Copyright, 2013, MPI, LLC 24

25 Relationship of Design Review to Verification and Validation In most cases, verification activities are completed prior to the design review, and the verification results are submitted to the reviewers along with the other design output to be reviewed. Similarly, validation typically involves a variety of activities, including a determination that the appropriate verifications and reviews have been completed. Thus, at the conclusion of the validation effort, a review is usually warranted to assure that the validation is complete and adequate. Copyright, 2013, MPI, LLC 25

26 Assessments..Product Audits..Process Audits To meet the design review comprehensive requirement, assessments should include a formal review of the main device and subsystems, including accessories, components, software, labeling, and packaging; production and resource needs; and installation and service, if needed. Copyright, 2013, MPI, LLC 26

27 Applications..Focused..Classification The extent and frequency of design reviews depends on the complexity and significance of the device being evaluated. Copyright, 2013, MPI, LLC 27

28 Design Review - Logistics Copyright, 2013, MPI, LLC 28

29 Design Reviews in the Design Plan Control of the design review process is achieved by developing and implementing a formal design review program consistent with quality system requirements. The following issues should be addressed and documented in the design and development plan(s). Number and Type of Reviews Selection of Reviewers Design Review Procedures (Logistics) Relationship of Design Review to Verification and Validation..In practice, design review, verification, and validation overlap one another, and the relationship among them may be confusing. As a general rule, the sequence is: verification, review, validation, review. Copyright, 2013, MPI, LLC 29

30 Vehicle for Inputs..Internal..External..Clinical Use When the design process is a redesign of an existing device, a special effort should be made to assure that data obtained from previous failures, complaints, and service records are made available and reviewed by those responsible for design, design input and design review. Quality Data QRB Design Review Copyright, 2013, MPI, LLC 30

31 Scheduled in the Design Plan..Agenda..Resources Preparation For Reviews The designated moderator or other designated employee should announce the formal review meetings with appropriate lead time and include an agenda. Copyright, 2013, MPI, LLC 31

32 Prepare..Distribute..Prepare..Simplicity Persons who are making presentations should prepare and distribute information to help clarify review issues and help expedite the review. However, the intent of the quality system is not that presentations be so formal and elaborate that designers are spending excessive time on presentations rather than on designing a safe and effective device. Copyright, 2013, MPI, LLC 32

33 Design Reviews for Learning and Sharing Ideas Persons who plan to attend a review meeting should come prepared to discuss the key issues on the agenda and issues related to the current design phase. Design review meetings are a great educational forum.. Don t forget the deliverables.. Copyright, 2013, MPI, LLC 33

34 The Design Review can open and close gates However, design review meetings should not be used as a primary tool to educate or bring new employees or unprepared employees up-to-speed. To do so detracts from the intent of the meeting and detracts from the intent of the GMP requirements. Copyright, 2013, MPI, LLC 34

35 Agenda..Minutes..Design Changes..Transfer Design reviews are conducted for design definition, selection and adequacy; communication; and resolution of problems and issues. Copyright, 2013, MPI, LLC 35

36 Resolve conflicts objective evidence not just chatter The design review of the initial requirements allows input from all parties. Various people may participate and "buy in" or "become part of the program." As the design input and review activities progress, any conflicts are resolved and the preliminary specifications for the device, accessories, labeling, and packaging are established Copyright, 2013, MPI, LLC 36

37 Design Reviews Importance and ROI Design reviews reduce errors, help avoid problems, help find existing problems, help propose solutions, increase producibility and reduce production transfer problems. The relentless inquiry during design reviews will expose needed design input requirements and/or design corrections that otherwise may have been overlooked. Copyright, 2013, MPI, LLC 37

38 Full Process Reviews..Sub-process Reviews Design review meetings may be grouped into two levels such as: 1. total or major program review meetings, and 2. sub-program or team review meetings. Copyright, 2013, MPI, LLC 38

39 Interface Requirement...Satisfy the QMS Requirements Some of the review meetings need to be total or major program review meetings because this is the only type of review meeting that will satisfy all of the GMP review requirements, particularly the interface requirement for interaction between or among different organizational groups Copyright, 2013, MPI, LLC 39

40 Open Conversation..Cross-Functional..Third Party Sub-program, team and contractor review meetings that are design review meetings, are subject to quality system design controls, and should be conducted in a manner that meets the GMP requirements. Sub-program or team meetings are encouraged as these can be very effective and efficient in reviewing and resolving sub-program issues. 21 CFR, Part Independent Reviewer ISO (Subject Matter) Expert Copyright, 2013, MPI, LLC 40

41 Examples only..depends upon the Scope of the Project Resources..Changes..Formalized The device design review meeting minutes should include information such as: moderator and attendees, date and design phase/stage, plans and/or agenda, problems and/or issues to identify and solve, minutes and reports, and follow-up report(s) of solutions and/or the next review covers the solutions and remaining issues. Copyright, 2013, MPI, LLC 41

42 Design Review Random Notes Copyright, 2013, MPI, LLC 42

43 Forms? Manufacturers may use a form to capture some of this information for minutes such the device, date, moderator, attendees, major phase, problems, assignments, etc. The device design review minutes are a key and required part of the design history file. Copyright, 2013, MPI, LLC 43

44 Ideally, coordinated effort..design Review..Stages Initial production and subsequent validation are well defined stages; and, therefore, design review(s) shall be performed as required by (e), Design Review. The design validation of initial production should be followed by a "final" design review to meet the design review requirement. Copyright, 2013, MPI, LLC 44

45 Transfer Discussion Design Review No design team can anticipate all factors bearing on the success of the design, but procedures for design transfer should address at least the following basic elements. - First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the manufacturing specifications. - Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved. - Third, the procedures should ensure that only approved specifications are used to manufacture production devices. The first item on this list may be addressed during design transfer. The second and third elements are among the basic principles of document control. As long as the production specifications are traditional paper documents, there is ample information available to guide manufacturers in implementing suitable procedures. Copyright, 2013, MPI, LLC 45

46 DHF Content (examples) Typical documents that may be in, or referenced in, a DHF are listed below: -design plans; -design review meeting information; -sketches; -drawings; -procedures; -photos; -engineering notebooks; -component qualification information; -biocompatibility (verification) protocols and data; -design review notes; -verification protocols and data for evaluating prototypes; -validation protocols and data for initial finished devices; -contractor / consultants information; -parts of design output/dmr documents that show plans were followed; and -parts of design output/dmr documents that show specifications were met. Copyright, 2013, MPI, LLC 46

47 Thank You John Gagliardi MidWest Process Innovation, LLC Copyright, 2013, MPI, LLC 47