3.6. Interpretation, Application, & Discussion (Design & Development Planning)

When the FDA says… “shall establish and maintain plans”…. they are indicating that the plan needs to be documented, implemented and revised as product development progresses. Updates to the plan may be scheduled to coincide with planned phases and/or on an as needed basis. Some projects that are straight forward with low risk may only require the plan to be updated at specified intervals according to the project plan or standard operating procedures. On the other hand, in scenarios where there are technical challenges and high project risks, the plan may be updated many times to accommodate delays that are typically experienced in these situations. 

 

 

 

Quality Systems Regulation Preamble States:

Comment 71

“This section has been revised to state that ``plans shall be reviewed, updated, and approved as design and development evolves,'' indicating that changes to the design plan are expected. A design plan typically includes at least proposed quality practices, assessment methodology, recordkeeping and documentation requirements, and resources, as well as a sequence of events related to a particular design or design category. These may be modified and refined as the design evolves. However, the design process can become a lengthy and costly process if the design activity is not properly defined and planned. The more specifically the activities are defined up front, the less need there will be for changes as the design evolves.” (FDA Preamble, 2015)

The FDA also says,…. “plans that describe or reference the design and development activities”… The regulation gives the flexibility of “describing” or making “reference” to the “design and development activities”. The FDA uses this wording to give manufacturers flexibility during development of the plans and therefore can be written for a wide range of device design complexity. For relatively simple medical devices (such as surgical gloves), the design and development plan (DDP) may fully describe in great detail all that is required to plan the development of the device. On the other hand, complex devices such as MRI machines may require a DDP that references many other sub-plans that are approved separately from the overall governing DDP. In this case sub-plans may be needed to address the development of typical aspects of the device such as software, hardware and electrical systems. Each of these areas is highly technical and complex and may need their own sub-plan to adequately define the development activities and assignments. In addition to sub-plans that reference technical aspects of the design, other typical sub-plans may include a regulatory plan, validation master plan, labeling plan, risk management plan, quality plan, detailed project schedule, etc.

The word “activities” in this regulation means just about anything that is performed by an individual or team in the process of developing the device. The “activities” (which often result in deliverables) that are required to complete development of the device should be included in the DDP. The FDA specifically states that the plan should “define responsibility for implementation” of these activities or deliverables. In simple product development projects with small teams it is ideal to assign individuals that will actually be performing the activities. In complex projects where activities are completed by teams, it is more common to see the names of the project leads or department heads that are assigned to those activities. Some companies choose to put the department names or functional groups that are assigned to the activity, but more often than not it is preferred to assign a name to the activity. When names are assigned, people take notice. It is more likely that if one person is assigned a task, they will take ownership of ensuring the activity gets completed on time. In cases when whole departments are assigned, the possibility exists that no one will take responsibility and deliverables won’t get completed on schedule.

 

Quality Systems Regulation Preamble States:

Comment 69

“In making this change, FDA notes that Sec. 820.20(b)(1) requires manufacturers to establish the appropriate responsibility for activities affecting quality, and emphasizes that the assignment of specific responsibility is important to the success of the design control program and to achieving compliance with the regulation. Also, the design and development activities should be assigned to qualified personnel equipped with adequate resources as required under Sec. 820.20(b)(2).” (FDA Preamble, 2015)

When the FDA states, “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, what they are really trying to say is that they want the manufacturers to thoroughly think about and plan what resources are required, how they are going to interact with each other and how are those interactions are going to effectively produce the desired result.

In practice, one of the best ways to present these interactions is in some type of matrix^BP1 which correlates deliverables (or activities) vs. resources, start dates, finish dates, targeted design phase, document number of deliverables (for traceability), etc.

Quality Systems Regulation Preamble States:

Comment 70

“Many organization functions, both inside and outside the design group, may contribute to the design process. For example, interfaces with marketing, purchasing, regulatory affairs, manufacturing, service groups, or information systems may be necessary during the design development phase. To function effectively, the design plan must establish the roles of these groups in the design process and describe the information that should be received and transmitted.” 

 

#1 Best Practice – Use matrices to communicate the interaction or correlation of information

Using matrices is often an effective method for communicating development plans to management, the development team and the FDA. During a typical inspection the FDA may review thousands of pages of documents, therefore any tools that will increase the efficiency of communicating this massive amount of information to reviewers should be implemented if possible. 

As the old saying goes, “the devil is in the details.” Effective planning will allow engineers, project managers and executive management to fully understand the scope and extent of the work required to complete device development and will give management the information needed to allocate adequate resources to the project and to set realistic timelines.

 

Those that have worked in the medical device industry and with the FDA have come to realize that the FDA is BIG on planning, VERY big on planning, and rightly so. As a general rule, the FDA wants to see this pattern:

 

1. Plan the activities
2. Perform the planned activities
3. Report what activities were actually performed and the results of the planned activities

 

The first step of this pattern is the planning step which also includes documents like verification and validation protocols (step two and three are implementation and reporting which will be discussed in later chapters).

 

When the FDA states, “The plans shall be reviewed, updated, and approved as design and development evolves,” they are trying to convey that the plan should be thoroughly understood, revised as needed, and formally approved throughout the development process.

 

Quality Systems Regulation Preamble States:

Comment 69

“Therefore, the approval is consistent with ISO 9001:1994 and would not be unduly burdensome since the FDA does not dictate how or by whom the plan must be approved. The regulation gives the manufacturer the necessary flexibility to have the same person(s) who is responsible for the review also be responsible for the approval of the plan if appropriate.” (FDA Preamble, 2015)

It is best practice to have a draft version^BP2 of the design and development plan (DDP) which should typically be reviewed individually and in design reviews. Prior to approval of the DDP, the approvers should be given sufficient time to read and understand the DDP content and intent of the plan. After reviewers have had the opportunity to read the DDP, it is best practice^BP3 to review the DDP during a design review which will give all attendees the opportunity to address (or challenge) any concerns or issues that may arise. As a result of the review, decisions will be made and actions will be assigned that may require updates to the DDP. This may include changing unrealistic target dates, deliverable assignments or updates with new requirement deliverables.

 

#2 Best Practice – Have documents in draft status for design review prior to approval                                                                                 

To increase the efficiency of the review and approval process, “near final” drafts of documents (prior to design review) should be reviewed by the design review attendees. After the results of the design review are documented, the drafts of the documents can be easily updated and then approved to reflect the outcome of the design review. 

 

#3 Best Practice – Reviewers should be given sufficient time to review documents prior to design reviews and approval.

Reviewers should be given sufficient time to review all documents prior to approving and holding a design review. If insufficient time is provided, reviewers may be inadequately prepared for design review discussion and/or individual review prior to document approval.  

 

It is important to understand that the DDP should be used as a living document. Just as product development can never be perfectly planned from the beginning, neither can the DDP be completely and accurately written to predict the future. As required changes in the development process occur, the plan should be updated periodically. The FDA is very aware that product development is often unpredictable and that plans often change. As a matter of fact, the FDA expects to see multiple revisions of the DDP and may be suspicious if it was never revised. The decision to update the DDP should be based heavily on when significant changes to the development of the product are required. The DDP should be updated as discussions of deviating from the current approved plans become finalized.

Typically the initial version of the DDP may only include the initial plans that are known at that point in time and therefore the plan will have relatively minimal content. As product development progresses the plan should be updated as additional information becomes available. As an example, the initial revision of the DDP may include deliverable dates that are specified by quarters of the year (3 month time period). As the target dates get closer and more confidence and understanding of the deliverable requirements are understood, the deliverable date will most likely be able to be refined within a month, week or even a specific day.

Approval of the DDP (as well as other documents) is typically performed by a handwritten signature and date or by an electronic signature (see 21 CFR part 11), either of which is an acceptable document approval method. If hand written signatures are used for approval it is best practice to provide the printed name next to the signature line to allow easy association of names with signatures if required during an FDA inspection or internal audit.   Either type of approval method is acceptable as long as 21 CFR part 11 is followed for electronic signatures on a validated software system. These approval methods are applicable for all design and development documents that are subject to FDA inspection.

The development activities and resource assignments indicated in the DDP typically affect many departments and therefore require a greater number of approval signatures than other development documents (e.g. risk assessments, design inputs, verification protocols). In small to medium size companies, approvals will typically include executive level management members such as VP of Quality, VP of Engineering, VP of Marketing and VP of Regulatory Affairs. In larger corporations, lower to mid-level management will typically approve the DDP. The intent of having executive management approve the DDP is twofold: 1) To receive management’s approval of the team’s plan to develop the product 2) To receive approval of resources (e.g. people, money, equipment) that the project manager has requested. Other department heads and Stakeholders should also be considered as approvers and/or to provide input to the DDP as appropriate for the organization. The FDA does not directly specify that the stakeholders are required to approve the DDP but they do indicate under 21 CFR 820.20 (Subpart B, Management Responsibility) that management should be involved and aware of activities pertaining to the quality system.  Figure 6 below indicates typical stakeholders that will have significant input to the DDP.