In our first article discussing “timing” in the context of designing a new medical device, we discussed the technical feasibility process (TFP), or the stage in which medical device concepts are designed and matured prior to the initiation of the formal design control process. It has long been a subject seldom discussed but is a critical stage of the overall design process and when carried out inefficiently or inadequately can lead to significant challenges downstream.
We highlighted what we consider to be the primary objective of the TFP - to create conceptual designs that encourage an organization to support the risk-based business decision of initiating the design control process. PLT discussed several strategies and approaches and explained in detail our reasoning for why generating evidence during the TFP is so important. This was followed by a summary of recommendations and best practices for carrying out the TFP as efficiently as possible to best position a medical device manufacturer for success when initiating the design control process.
In this next series of articles, we want to again call attention to best practices and the importance of “timing”. Figure 1 illustrates our contention that best practices are initially dominated by engineering best practices but begin to include compliance best practices as the project progresses. Additionally, properly timing when to fully compliant with specific quality procedures can help improve the efficiency and overall success of a project. For each article in this new series, we will present PLT’s recommendations for when a team should consider implementing a specific quality procedure.
In Figure 1 we present three segments of the device design process. We use these segments to support our discussion on the timing of quality procedure compliance along with additional strategies to support these activities:
1) During the TFP
2) During the transition from TFP to the Design Control process, and
3) During the Design Control process
This new series of articles will discuss salient procedures individually in the order in which PLT recommends beginning to fully comply with throughout the design process.
Figure 1: Overview of design process stages from TFP to initiation of Design Controls
QMS introduction
An important question to answer before we get started is “What is a Quality Management System (QMS)” and “why are they helpful”? A QMS is a set of procedures that an organization establishes to provide staff with guidance on how to accomplish a certain task or group of tasks. They are not unique to the medical device industry, however a medical device manufacturer’s QMS must comply with all regional medical device specific regulations in which their device(s) is/are sold. For example, manufacturers of medical devices sold in the United States must have QMS procedures that comply with Title 21, subchapter H, part 820 Quality System Requirements.
A medical device manufacturer’s QMS is analogous to a compass. It aligns a manufacturer with the relevant regional regulations (their north star) to support compliance. Further, the QMS provides alignment for staff with these regulations, setting employees on a course for executing activities and operating within a compliant environment for the entire lifecycle of all products, and the life of the organization. A challenge for employers is ensuring all employees understand and properly follow these procedures, and procedures are regularly updated to remain current.
TFP QMS implementation – Purchasing Controls and Acceptance Activities
Purchasing controls are applicable when an organization does not have direct control over the product or services received that could potentially impact the quality of the medical device. A good rule of thumb is to determine if these products or services are covered under the organization’s quality system and subsequent internal quality audits, and if they are not purchasing controls apply.
Purchasing controls may be used to cover externally sourced:
a. Product – includes components, manufacturing materials, in-process devices, finished devices, and returned devices – 21cfr820.3(r)
b. Components – any raw material, substance, piece, part, software, firmware, labelling, or assembly which is intended to be included as part of the finished, packaged, and labelled device – 21cfr820.3(c).
c. Services – parts of the manufacturing or quality system that are contracted to others, for example, plating metals, testing, and sterilizing… - FDA Response to comment #102 [Preamble to 1996 QS Regulation]. Services include consultants.
The degree of control necessary is related to the product or service purchased. As the design process progresses, alignment with risk assessment conclusions is an excellent strategy for ensuring an appropriate level of control is employed.
Acceptance activities are procedures established and maintained by a manufacturer that use inspections, tests, or other verifications to accept incoming product, in-process product, and finished devices and ensure they conform to specified requirements.
As a manufacturer begins creating very early prototypes, they are almost certain to begin working with suppliers, providing either components and/or technical services. Requiring team members to follow purchasing controls and acceptance activities procedures ensures a level of quality early in the process of designing a new device. It provides reassurance to the manufacture in several ways:
1. Suppliers have been appropriately and sufficiently vetted and have been added to the approved suppliers list.
2. Processes are in place internally, and at a device manufacturer’s approved suppliers, to ensure a sufficient level of quality and to prevent issues/non-conformities that will confound test results.
3. Changes (both internal or external) are being monitored and reported as necessary to ensure design documentation remains up to date and in alignment with test results
4. Any gaps with accumulated test data and reports are known or can be easily identified and addressed.
The priority during TFP should be first ensuring all material used for generating evidence is of the utmost quality, and adequate procedures are in place to guarantee that. For larger medical device manufacturers an existing process will most likely be in place. Since it is common to work with existing approved suppliers first, requiring R&D groups and external suppliers to follow purchasing control and acceptance activity procedures may not be difficult to enforce or require a significant effort to ensure compliance, therefore management is unlikely to encounter resistance. For smaller, less experienced organizations, it may take longer to create, initiate, and obtain commitment to follow these procedures, but over the long term they will help establish a culture of quality. For manufacturers designing products for the US market, they should ensure their procedures comply with 21 CFR subpart E, 820.50 – Purchasing Controls and subpart H, 820.80 – Acceptance Activities.
Recommendations:
We have several recommendations stemming from the introduction of purchasing controls and acceptance activities:
1) Once complying with purchasing controls and acceptance activities, they provide certainty in the assessment process. It also provides an opportunity to establish and refine QC documentation and procedures at a time when the team isn’t heavily burdened by quality requirements.
2) It should be noted that devices manufactured following these procedures should be labelled in accordance with the maturity of the process.
3) Implementation order – purchasing controls and acceptance activities are the first procedures in the design process to be complied with. Dependable, meaningful data can only be generated once QC inspected components and equipment are being used in testing.
4) Use supplier agreements to capture all expectations and ensure agreement is reached by both parties prior to establishing requirements in procedures.
a. Include an expectation that the notification of change controls be provided before the implementation of those changes, and ensure this requirement is being followed, particularly for suppliers over which a manufacturer has limited control.
b. Note the changes included as part of this requirement, such as design changes, process changes, or supplier changes.
5) Purchasing controls and acceptance activities will be revised throughout the design process, and particularly once the design control process begins, as these procedures will change as design requirements and risk management activities progress.
As mentioned earlier, the priority during TFP should be to ensure all material used for generating evidence is of the utmost quality, and adequate procedures are in place to guarantee that. As the TFP approaches completion, the teams’ priorities can then shift to establishing document/version controls, which we will discuss in our next article.
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