This article describes best practices in managing your design change control process, including a list of the ten most common mistakes.
During every visit by FDA inspectors, and CE Marking auditors, the changes you have made will be reviewed. The focus by inspectors and auditors is: 1) to verify that your design verification and validation was adequate for the changes, and 2) to verify that necessary regulatory approval of the changes was obtained. Due to this scrutiny, your design change control process is one of the most important processes to manage well.
Ten most common mistakes in managing design change control
- Failure to carefully update drawings and specifications. Often these errors are typos, but it is essential to perform a thorough review of all your drawing dimensions, tolerances, notes, etc.
- Failure to update procedures and work instructions, especially inspection instructions. As a quality system becomes more mature, it becomes harder to identify all the places where a reference is found. If you have a 100% electronic quality system, with the ability to include cross-references, finding the related documents is easier. MasterControl uses “info cards.” It is possible to do this in any system by adding tags to your master document list. The “tags” can be standards, regulations, other procedures, and forms.
- Failure to validate inspection methods. Often a new inspection tool or method may appear to be better, but it is important to re-validate inspection methods whether you are changing: 1) design, 2) inspection tools, or 3) inspection methods. A Gauge R&R study is an example of one method for the validation of inspection methods.
- Failure to re-verify and re-validate your design. In general, whenever you make a design or process change, you need to repeat your verification and validation that was initially performed. You may be able to abbreviate the verification and validation testing. Still, if you cannot provide a justification for the abbreviated method, then you should use the same method and the same acceptance criteria. This presents an enormous burden for any device that required a clinical study to demonstrate safety and effectiveness. This is also why it is so expensive to implement changes in CE Marking for Class III devices, and FDA approved Class III PMA devices. In both cases, there is typically a large supplement required for regulatory approval.
- Failure to update your risk management documentation and post-market surveillance plans. Risk management files and post-market surveillance plans are meant to be “living documents.” Therefore, whenever you make changes, even minor ones, you should document your evaluation of the need to update the risk management file or your PMS plan. If the changes planned are related to a CAPA or recall, it is critical to verify the effectiveness of the changes made. This verification is both verification of the design change and the effectiveness of your risk controls. It will also be critical to document the change in the PMS plan by identifying potential confusion and use errors associated with your change.
- Failure to change UDI. Most companies created their change control procedure in the early stages of their quality system, and very few revisions and updates are made to the change control procedure and associated forms. Your UDI process and procedure are probably much more recent, and many companies forget to add UDI requirements to their change control process. It is important to update your device identifier, not only for regulatory compliance but also as a tool to help your company better track which quality issues are related to the previous version of your device and which quality issues are limited to the new version.
- Since the EU MDR requires that DI portion of your UDI is included in your Declaration of Conformity, this is another document to make sure you update when you make a design change. I recommend identifying the date (or lot) of first CE Marking and last CE Marking for your previous version in an updated Declaration of Conformity. Then you will also need the date of first CE Marking for the new version of your product. This can create a very long and complicated declaration. Still, it is important to control these transitions in anticipation of potential complaint investigations during the period of time when both versions are in distribution/use.
- Failure to update your technical file and device master record (DMR). Every time you change a drawing, specification, tolerance, testing method, etc. you need to update your technical documentation and DMR. This is why using a Technical File Index, and DMR Index are considered best practices. These tools just list all the related controlled documents and the current revision. The best indices will also identify how revisions were controlled (e.g., change notification or design change order). You might even identify which CE Certificate or 510(k) clearance is associated with each item in the index. This is especially helpful when you have multiple accessories involved. FDA inspectors will verify that you updated your DMR, and they will review the MDR for design changes that were not adequately validated. Your Notified Body will also review changes made to your Technical File to make sure you have notified them of changes or obtained prior approval to commercial release.
- Failure to document your rationale for no new regulatory approval. Whenever you make a change, you need to document your rationale for whether a new regulatory submission is required. You should have a systematic method that is documented. The FDA has published two guidance documents with decision trees to assist with this decision for 510(k) cleared products: 1) Deciding When to Submit a 510(k) for a Change to an Existing Device, and 2) Deciding When to Submit a 510(k) for a Software Change to an Existing Device. For CE Marking and Canadian Licensing, there are guidance documents on determining when a submission is required for significant changes. Regardless of your decision, you need to document the decision, and the form you use to document this decision should be a controlled form within your change control process.
- Failure to notify suppliers of your changes. Whenever you make a change, it is critical to notify your suppliers of the change. However, you also need to determine if the change may impact any open purchase orders. Will you need to rework or scrap any work in progress? Will you need to coordinate the use of components so that all components are used up before the change? There may even be obsolete inventory that you need to disposition as “use-as-is” or “rework.”
Create controlled templates for verification and validation testing
For every verification and validation test that you perform, you should have some kind of documented testing plan or formal protocol. Plans are more appropriate when the testing will be outsourced to a lab that has their testing protocols. If you are performing the testing in-house, you should have a formal protocol that references any internal testing work instructions that may be relevant and any testing standards that apply. The protocols should also be designed for “fill-in-the-blank” use to facilitate reuse of the protocol for multiple devices. Protocols should also identify the following required elements: 1) facilities needed for testing, 2) calibrated devices needed for measurement, 3) any controlled documents or standard referenced in the protocol, 4) sample requirements, 5) acceptance criteria, and 6) statistical rationale for sample sizes. The FDA also released a guidance document defining the format and content for testing reports. Whenever a standard is revised, it will also be important to assess the impact on current regulatory approval. CE Marked products will need to be retested to the new standards, or at least a scientific justification must be provided. By maintaining these plans and protocols as controlled documents, you will be able to execute testing plans and protocols much more quickly and consistently. You may also want to consider maintaining an appendix for testing plans that identifies any vendors and contacts for obtaining quotations for new testing.
Organizing design change control approval forms
One of the biggest mistakes people make is to try and streamline questions down to checkboxes or yes/no questions. For example, don’t ask the question, “Is 510(k) clearance required for this change?” Instead, require the person always to fill out a form to document the decision for whether a 510(k) is required or not–which should also be a controlled form. Don’t ask the person if there is an inventory that is affected by the change. Instead, ask the person to identify how many units are at each stage of the process (i.e., pending purchase orders, inspection quarantine, and finished good inventory). Then ask the person to identify the disposition for the product at each stage. This would typically be documented with a nonconforming material record (i.e., NCMR). You should also define which roles and responsibilities complete each part of your form unless you have a small company where key individuals are responsible for multiple roles.
Who should approve design changes?
There is no specific requirement for who must review and approve changes, but each document that is revised and updated will need to be reviewed and approved by the same functions that approved the previous version. Therefore, it would make sense that the same functions that reviewed and approved the design in a final design review should also be involved in the review and approval of a design change for the same device. There is no requirement for an independent reviewer for design change review and approval. Still, I have observed so many mistakes, and I think an independent reviewer and approver are extremely valuable for design changes.
What if you are facing a deadline
There is always pressure from peers and superiors to release design changes to the market as soon as possible. In theory, everything new is better, but this is often untrue. Forcing everyone to follow your change control process is intended to prevent the release of a product that is not ready for release. Therefore, you should fill out as much of your design change approval form at the beginning of a design change as possible. This will help everyone identify the documentation updates at the beginning. All the documentation and testing that is required should be planned, target dates for completion of each update should be documented, and the person responsible for each updated document should be identified. By documenting your plan and maintaining that plan, everyone will know what needs to be completed before a modified device can be released. By controlling the changes in this way, it becomes the responsibility of the whole team to make sure the responsible person and on-time complete each document. If you adopt this strategy, more device changes will be released on-time. You will also find that fewer mistakes will be made, and the team will share the burden of meeting launch deadlines.
Are “full” design controls required?
For minor design changes, you don’t want to apply “full” design controls and create a new design history file (DHF). However, you may want to create a shorter version of a design plan to document what level of control is required and how the project will be managed. This could be as short as a page, but it is likely to be several pages. The following is a list providing examples of things you might document in the abbreviated plan for control of design changes:
- Previous regulatory approvals [e.g., 510(k) number]
- Applicable Technical File or DMR Index that will be updated
- Any new risks identified
- Any new applicable standards
- Approved Design Inputs (indicate if changes are needed)
- Design Outputs that need to be updated (consider highlighting in your DMR index)
- Changes to your supply chain (e.g., process changes, supplier changes, supplier quality agreements, and process changes)
- Process validation and Revalidation required
- Labeling and UDI changes
- Obsolescence of inventory and reverse/forward compatibility of components
- Impact on service procedures and/or providers
- Changes and changeover of internal calibrated tooling and testing stations
What if you are making a design change before a product is commercialized?
The quality system requirement for control of design changes also applies to changes made before the release of a product. During the design process, changes made before “design freeze” will be frequent. For these changes, you want to make the process as simple as possible. Once you begin purchasing capital equipment and performing verification or validation testing, now the design changes are costly. This is when you really must have tight control of changes. Many companies designate that drawings and specifications have begun design transfer when the revision changes from a number (e.g., 1, 2, 3) to a letter (e.g., A, B, C). This helps identify any documentation that will now require tighter design change control. If the design is being conducted internally, then a representative of top management may need to approve changes. If a contract design firm is conducting the design, then approval by the customer may be required for any changes during design transfer.
Additional design change control resources
If your firm needs a procedure for design change control, please visit our webpage for our Change Control Procedure (SYS-006). If you are interested in Design Controls, before the release of a product from the design process, please visit our webpage for the Design Change Procedure (SYS-008).