Design Quality. Indu Lakshman

Transcription

1 Design Quality Indu Lakshman

2 Overview New product development (NPD) covers the complete process of bringing a new product to market. In commercial terms, new product development is described in the literature as the transformation of a market opportunity into a product available for sale.

3 Product Development Process A process management approach is used to provide a structure for NPD consistency and to enable continuous improvement. Every new product will pass through a series of stages from idea through design, manufacturing and market introduction.

4 Quality Management Systems

5 What are design controls? To ensure that good quality assurance practices are used for the design of medical devices and diagnostics. Design controls designates the application of a formal methodology to the conduct of product development activities. Control the design process to assure that the device meets: o o o o User needs Regulatory requirements Intended uses Specified requirements Can improve and prevent future issues. Use design controls to build quality, safety, effectiveness into your medical device

6 Design Controls - Regulatory History Safe Medical Device Act of 1990 authorized FDA to add Design Controls to the current Good Manufacturing Practice (cgmp) requirements for medical devices. The Quality System (QS) Regulation became effective on June 1, 1997 and replaced the 1978 GMP for medical devices. Note: Preamble to the QS Regulation is extremely important for understanding the intent of Design Controls.

7 When to start Design Controls? Where exploratory research ends and design begins After Feasibility/ Proof of Concept [some say]

8 FDA QSR Design Controls 21 CFR Part General: Each manufacturer of any class III or class II device, and the class I devices [as listed below], shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Devices automated with computer software Tracheobronchial suction catheters Surgeon's gloves Protective restraints Manual radionuclide applicator system Radionuclide teletherapy source

9 Design and Development Planning Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

10 Design Input Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, regulatory requirements, including the needs of the user and patient. Address incomplete, ambiguous, or conflicting requirements The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

11 Examples of Design Input Device functions Physical characteristics Performance Safety Reliability Standards Human factors Labeling & packaging Maintenance Sterilization Compatibility with other devices Regulatory requirements Environmental limits

12 What is Risk Analysis? ISO is a well recognized standard to follow Intent of Risk Analysis Identify possible hazards, including use error Calculate risk, under normal and fault conditions Determine risk acceptability Reduce unacceptable risks to acceptable levels Ensure changes made do not introduce new hazards

13 Risk Analysis [an example]

14 Risk Value or Priority Number [an example]

15 Design Output Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented

16 Design outputs are the results of a design effort. Define and document design output to allow adequate evaluation of conformance to design input. (i.e., input = output) - The finished design output is the basis for the Device Master Record (DMR).

17 Design Reviews Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

18 Design Verification Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

19 Design Validation Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF

20 Design Verification vs Design Validation Design - Verification vs. Validation Design Verification Output meets Input I made the product correctly. Design Validation Specifications meet user needs and intended use(s) I made the correct product.

21 Design Transfer Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

22 Design Inputs to Design Outputs

23 Design changes Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation [design controls continual role in post market development] Design history file Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

24 Design History File Planning Stage Inputs & Outputs

25 Software Development Lifecycle

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27 Appendix ISO Product Realization

28 ISO Product Realization Establish and maintain: Processes to control product realization and risk management activities including: Processes to determine, review and fulfill regulatory, customer and product requirements; Arrangements for customer communications; Processes for product design and development; Processes to control suppliers, and purchasing activities and information; Processes to control production, installation, distribution, and servicing; Processes to define and perform process validations; and Processes to control monitoring and measuring devices. Establish records such as: Risk management records; Records of regulatory, customer and product requirements reviews; Design and development records; Supplier evaluation and purchasing records; Production, installation, distribution, and servicing records; Equipment maintenance and calibration records. Inputs received from: Resource management; Documentation; Customers; Regulatory agencies. Outputs provided to: Measurement, analysis and improvement; Documentation; Customers; and Regulatory agencies.

29 Product Realization - Procedures are established and maintained for product realization planning activities, including risk management activities, to ensure that customer and product requirements are met. - As part of the product realization planning activities, the following are determined: o product quality objectives and requirements; necessary processes, documents and resources specific to the product; o verification, validation, monitoring, inspection and test activities specific to the product; and o product acceptance criteria; Records of product realization activities, including risk management activities, are maintained.

30 Customer-related Processes Determination of requirements - Procedures are established and maintained to determine customer and product requirements, both stated and unstated, but necessary for the INTENDED USE of the product, applicable statutory and regulatory requirements, and any other requirements determined to be necessary. Review of requirements related to product - Procedures are established and maintained to review customer and product requirements prior to the commitment to supply a product to the customer. The review ensures: - product requirements are defined and documented; contract or order requirements differing from those previously expressed are resolved; and Communication Effective arrangements for customer communications are determined and implemented with customers regarding the following: product information; enquiries, contracts or order handling including amendments; customer feedback, including customer complaints; and field actions.

31 Design and Development General The organization shall document procedures for design and development. Design and Development Planning The organization shall plan and control the design and development of product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses. During design and development planning, the organization shall document: a) the design and development stages; b) the review(s) needed at each design and development stage; c) the verification, validation, and design transfer activities that are appropriate at each design and development stage; d) the responsibilities and authorities for design and development; e) the methods to ensure traceability of design and development outputs to design and development inputs; f) the resources needed, including necessary competence of personnel.

32 Design and Development Inputs relating to product requirements shall be determined and records maintained. These inputs shall include: a) functional, performance, usability and safety requirements, according to the intended use; b) applicable regulatory requirements and standards; c) applicable output(s) of risk management; d) as appropriate, information derived from previous similar designs; e) other requirements essential for design and development of the product and processes. These inputs shall be reviewed for adequacy and approved. Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.

33 Design and Development Outputs Procedures are established and maintained to ensure that design output meets design input requirements for design and development, provide appropriate information for purchasing, production and for service provision, contains or references acceptance criteria, conforms to appropriate regulatory requirements and identifies those design characteristics that are crucial to safe, reliable, and proper functioning of the product. Design outputs are established and maintained in a form that enables verification against design and development inputs. The DMR, VERIFICATION and VALIDATION results and the product technical file and declaration of conformity comprise the design outputs that establish the specifications and procedures of the FINISHED PRODUCT, and show compliance with the PRODUCT REQUIREMENTS and RISK ANALYSIS.

34 Design and Development verification Procedures are established and maintained for design verification at appropriate stages of the design to ensure that the design stage output meets the design stage input requirements. Records of verification activities and any necessary actions are maintained.

35 Design and Development validation Procedures are established and maintained for design VALIDATION to ensure that product conforms to defined user needs and INTENDED USEs. Design VALIDATION is performed in accordance with the PROJECT PLAN, under defined operating conditions and on initial production units or their equivalents. Design VALIDATION includes software, RISK ANALYSIS and clinical evaluation, where appropriate. Design VALIDATION activities are successfully completed prior to the distribution of product. Records of validation activities and any necessary actions are maintained.

36 Design and Development transfer The Document Controls procedure is used for design transfer to ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications. Records of design transfer activities and any necessary actions are maintained. Control of design and development changes The prerelease section of the Document Controls procedure is used for the review and approval of design changes prior to implementation. Records of design changes and any necessary actions are maintained

37 Design and Development files The organization shall maintain a design and development file for each medical device type or medical device family. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.