Design Controls: Design Transfer, Changes and the Design History File

In this issue, we wrap up a series of six articles focused on the design controls process from a standpoint of design transfer, changes and the design history file (DHF) in the orthopaedic medical device marketplace. I hope that you have enjoyed reading the previous articles, which are all available online at www.orthoworld.com, in the BONEZONE archives.  –JG

Introduction and Review

As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical devices is required to establish and maintain a quality system that is appropriate for the specific device(s) designed or manufactured and that meets the requirements of 21 Code of Federal Regulations (CFR), Part 820. The details of design control systems will vary depending on the complexity of the orthopaedic device or process being designed.

Because design transfer must apply to a wide variety of devices and manufacturing systems, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework for transfer and any changes to the design that manufacturer must use when developing and then implementing this relationship between, for example, design engineers and manufacturing engineers.

This framework provides orthopaedic manufacturing companies with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes. Even very small manufacturers and those that design less-complex devices or processes are expected to define, document and implement design transfer procedures and other quality system procedures, as called for in the regulation. All changes must be accounted for during the design process.

Basically, most of the details of the change control system are left to the manufacturer to develop, document and implement. As the design activity progresses toward its final stages, it is expected that the degree of change control will increase. The Quality System Regulation (QSR) also requires that the DHF shall contain or reference the documentation necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

As noted, this requirement cannot be met unless the manufacturer develops and maintains plans that meet the design control requirements. The plans and subsequent updates should be part of this DHF in continuum.

Definitions of Regulatory/Quality Requirements from the CFR

§ 820.30(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

§ 820.30(i) 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.

§ 820.30(j) 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.

Design Transfer

The design controls require that each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. The transfer process must be a part of the design plan. It is not uncommon for the design to be transferred in phases.

For successful design transfer to occur, manufacturers have found that communication between manufacturing and design personnel must be initiated during early development phases and continued throughout the product’s life-cycle. Historically I have not seen this work very well, because development groups have often simply released specifications to manufacturing and have failed to ensure that the production specifications are well understood or effectively implemented.

Production specifications typically comprise written documents such as assembly drawings, inspection and test specifications and manufacturing instructions. These production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. If a manufactured device deviates outside of those capabilities, performance may be compromised. Thus, the process of summarizing knowledge about the device into production specifications is important for establishing the device’s quality throughout the life cycle of design controls, as well post-commercialization. This transfer of knowledge in the form of documentation (such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions and inspection and test specifications) from product development to the manufacturing process should be a well-orchestrated process resulting in the issuance of the Device Master Record (DMR) as part of the design output. (The DHF is the basis for the DMR.) This information becomes the basis for any other additional documentation, e.g.

  • documentation
  • training materials
  • digital data files
  • manufacturing jigs and aids

 

These are produced by other departments during the design controls process. This process of transfer is usually driven by a protocol with all of the necessary cross-functional authority in place on both sides of commercialization and design/manufacturing. Shortcomings in production specifications tend to be noticeable late in the product life cycle. When the design is new, there is often intensive interaction between the design and production teams, providing ample opportunity for undocumented information flow. Later, as production experience is gained, lack of meaningful engagement often occurs between design and production teams.

Particular care should be taken when the product involves new and unproven manufacturing processes, or established processes that are new to the manufacturer. The engineering feasibility and production feasibility may be different because the equipment, tools, personnel, operating procedures, supervision and motivation could be different when a manufacturer scales up for routine production.

No design team can foresee all factors bearing on the success of the design, but procedures for design transfer should include at least the following basic elements.

  1. Qualitative assessment of the completeness and adequacy of the production specifications
  2. Review and approval of all documents and articles that constitute the production specifications
  3. Confirmation that only approved specifications are used to manufacture production devices

The first item above may be addressed during design transfer. The second and third items are among the basic principles of document control and configuration management. As long as the production specifications are traditional paper documents, there is more than enough information available to guide manufacturers in implementing suitable procedures.

Many manufacturers conduct a final device design review near the end of the design transfer activities to ensure that the transfer was effective and complete.

Design Changes

Changes to design elements are controlled by the manufacturer, which must establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review and approval of these design changes before their implementation.

It is not the intent of the QSR to mandate that all design changes be documented and evaluated to the same extent, although they must all be documented and evaluated. The level of documentation and evaluation should be in direct proportion with the significance of the change.

Two principal administrative elements are involved in controlling design changes:

  • Document control: listing of design documents; tracking their status and revision history
  • Change control: enumeration of deficiencies and corrective actions arising from verification and review of the design; tracking their resolution prior to design transfer

A supportable process for managing change involves little more than documenting the design change, performing appropriate verification and validation and keeping records of reviews. The main objectives serve to ensure that:

  • Corrective actions are tracked to completion
  • Changes are implemented in such a manner that the original problem is resolved and no new problems are created, or, if new problems are created, they are also tracked to resolution
  • Design documentation is updated to accurately reflect the revised design

Design change control should be implemented using a set of standardized procedures similar to the following:

  • Issue a change request form
  • Perhaps issue a change order to implement the change
  • Issue an assignment to developers to further study the problem and develop a suitable corrective action
  • Communicate change requests and change orders to all persons whose work might be impacted by the change
  • Distribute and attach a copy of the change order to each controlled copy of the original document
  • Incorporate review and assessment of the impact of the design change on the design input requirements and intended uses
  • Track all change requests and change orders to ensure proper disposition

Note that Change Requests are administered by the document control staff within the design controls process, per se. This is a different team than the document control process owner(s) for the main Quality Management System. Changes during design require a similar authority for credibility purposes and demand a more expedited approach to changes.

The design control system has to be aligned with the creation and revision of documents, as well as the management of finished documents. Additional mechanisms are required to provide needed flexibility while preserving the integrity of design documentation.


Items for consideration when determining the extent to which changes should be selected for design control are as follows:

  • Initial design inputs should be under control
  • Change control is required for devices involved with clinical trials
  • Re-verification and/or re-validation could necessitate regulatory changes, as well as potential changes in the manufacturing/quality control/assurance arenas.
  • Specification changes affecting the device’s overall risk
  • Change to the device and/or its labeling
  • Change to the packaging (before and after production/commercialization)
  • Manufacturing processes
  • Quality Assurance processes
  • Elements of the DMR are subject to design control considerations
  • The level of verification and validation to be performed for sub-contractor changes (linkage to the “no change” agreement under purchasing controls)

After design transfer, formal change control processes are imperative for managing the intricacy of the device throughout its cycle of longevity.

As part of the change control process, manufacturers should always evaluate the proposed change for possible regulatory submission purposes, i.e. revised or new 510(k), or a supplement to an existing Pre-Market Approval (PMA). Planning is critical for changes to FDA cleared or approved medical devices.

Design History File

There is no specific requirement in ISO 13485:2003 for a design history file. However, in order to market a medical device in the U.S., a manufacturer must comply with FDA’s QSR, which requires a DHF.

Basically, every section of the design control requirements specifies information that should be recorded. The DHF is a compilation of records that describes the design history of a finished device. The DHF covers the design activities used to develop the device, accessories, major components, labeling, packaging and production processes. The design controls regulation requires that each manufacturer shall establish and maintain a DHF for each type of device. Each type of device means a device or family of devices that are manufactured according to one DMR. Certain basic design information may be maintained in a single project file in a specified location, and may include the following:

  • Detailed design and development plans specifying design tasks and deliverables
  • Copies of approved design input documents – information on intended use, performance, labeling and environment
  • Copies of design output documents: specifications, top-level drawings, major subassemblies and development of the DMR
  • Documentation of design reviews: minutes, assignments and tracking issues
  • Validation documentation: protocols, results of all tests and testing methodologies
  • Design Transfer: plans, protocols, authority documents to show process ownership
  • When applicable, copies of controlled design documents and change control records

Design control procedures often define the requirements of the DHF, such as:

  • Responsibility and authority
  • Process for adding information to the DHF
  • Organization of the DHF
  • Logistics of storage and filing
  • Audit frequency of the DHF
  • The means to provide changes to the DHF and other ancillary, linked documents, e.g., the DMR

 

Summary of the Design Controls Process:

Each manufacturer of either a Class II or Class III medical device (as well as a select group of class I devices) needs to establish and document procedures on the design and design requirements. These design controls include:

  • Design input: Typically, the initial requirements that describe the medical device to be produced.
  • Design output: The results of the design and engineering efforts. These are normally the final specifications for the device, including the manufacturing process and the in-coming, in-process and finished device inspection, measurement or test methods and criteria. The outputs are normally documented in models, drawings, engineering analysis and other documents. The output needs to be directly traceable to the input requirements. Design verification and validation should demonstrate that the final output specifications conform to the input requirements and meet user needs and intended uses.
  • Design review: A formal review of the medical device design by representatives of each design function participating in the design efforts, as well as other interested parties (e.g., marketing, sales, manufacturing engineering, etc.). The design review must be documented in the DHF and include review date, participants, design version/revision reviewed and review results.
  • Design verification: The process that confirms that the design output conforms to the design input. Design verification should demonstrate that the specifications are the correct specifications for the design. Design verification must be documented in the DHF and include the verification date, participants, design version/revision verified, verification method and verification results.
  • Design validation: The process whereby device design is validated using initial/low volume production processes. The purpose for the design validation is to confirm that the design functions according to design inputs when produced using normal production processes rather than prototype processes. The design validation must be documented in the DHF.
  • Design transfer: The process in which the device design is translated into production, distribution, servicing and installation specifications.
  • Design change: The process in which design changes are identified and documented. Also known as engineering change.
  • Design history file: A documentation artifact used in the medical device industry, this is a compilation of records that describes the design history of a finished device, including the design activities used to develop the device, accessories, major components, labeling, packaging and production processes. A DHF is required for each type of device or family of devices that are manufactured according to the DMR.

Design controls are a constituent of a comprehensive QMS that covers the life and life-cycle of a medical device. The assurance process is a total systems approach that extends from the development of device requirements through design, production, distribution, use, maintenance and eventually, obsolescence. Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes.

Design control does not end with the transfer of a design to manufacturing. Design controls apply to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market. This includes marked changes such as performance enhancements as well as innovative changes such as corrective actions resulting from the analysis of failed product. The changes are part of a continuous, ongoing effort to design and develop an orthopaedic device that meets the needs of the user and/or patient. The design control process is revisited many times during the life of a product.


Looking Back at Design Controls

Part I: A Business-Critical Tool. (BONEZONE Fall 2009) A systematic and organized approach is the goal in taking product-feasible ideas and bringing a finished device to market. The synergistic and harmonized relationship of all “players” involved is the key to commercializing devices, and meeting customer needs and regulatory requirements.

Part II: The Requirement for Planning. (BONEZONE Winter 2009) Having a written plan is not only a regulatory requirement, but also the “point of order” that is necessary to stay on course and control the destiny of an idea.

Part III: Inputs and Outputs in Synergy. (BONEZONE Spring 2010) Development of a solid foundation of requirements is the single most important design control activity.

Part IV: Design Review. (BONEZONE Summer 2010) Design reviews may have an internal and external focus. The internal centers on design feasibility and produceability with respect to manufacturing and support capabilities. The external centers upon user requirements.

Part V: Verification and Validation. (BONEZONE Fall 2010) Design verification is almost always done vs. specifications. Therefore, to control the specifications and increase the probability of achieving desired safety and performance characteristics, device, software, labeling, packaging and any other specifications should be complete and thoroughly reviewed before development commences.

Part VI: Design Controls: Design Transfer, Changes and the Design History File. (Current issue) Because design transfer must apply to a wide variety of devices and manufacturing systems, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework for transfer and any changes to the design that manufacturer must use when developing and then implementing this relationship between, for example, design engineers and manufacturing engineers.

Review these articles online by visiting the BONEZONE journal archives at www.orthoworld.com.

John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. Email John at This email address is being protected from spambots. You need JavaScript enabled to view it..

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