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3 Ways to Fix the 510(k) Process: Self-Surveys, Scorecards and Modular Submissions

In 510(k), Elsmar Cove, eSubmitter, Medical Device, PMA, pre-IDE, SmartForm, Turbo 510(k), US FDA on June 26, 2012 at 5:47 am

Modular submissions are already used for PMA submissions. Self-surveys and scorecards are tools that most companies utilize to evaluate vendors. Why not implement these solutions to make 510(k) reviews more efficient?

For entertainment we have Pomplamoose’s cover of “Single Ladies”. My wife Lisa is a big fan of Pomplamoose, and this song is one of my favorites.

A few weeks ago a posted a blog about the Triage pilot program at the FDA. I received some great comments by email and I thought I would go a little more in depth with some specific ideas for improvement of the 510(k) process. Here’s the argument for considering these three proven methods:

Self-Surveys

In my previous posting about the Triage pilot program, I suggested using the existing FDA traditional 510(k) screening checklist and converting this into a similar “SmartForm”. Another way to think of this concept is by comparing it with a “Self-Survey.” Self-surveys are sent by companies to suppliers in order to gather information about the supplier as justification for approving the supplier; Elsmar Cove has some discussion threads specific to the supplier self-surveys if you are unfamiliar with this method of torture. The critical step in the design of surveys is to require the submitter to provide references to procedures and forms or to explain why something is not applicable. This same strategy is used by BSI for their auditor combined checklists. Instead of checking “yes/no”, the auditor must reference a page in their audit notes where the objective evidence of conformity or nonconformity can be found. A submitter should fill in the checklist, rather than an FDA reviewer, because this forces the submitter to verify that everything required is included. Canada has a similar requirement called a “submission traceability table” for Medical Device License Applications (see Appendix A). Self-surveys also replace some of the tedious searching by a reviewer with cross-referencing work by the submitter.

Scorecards

Another tool that supplier quality uses for supplier evaluations is the Scorecard; Elsmar Cove has a few discussion threads including one with an example to download. For the purpose of the 510(k) process, I suggest developing scorecards for both the reviewer AND the submitter. The primary metrics for these scorecards would be on-time delivery and completeness of the submission for a submitter. The “on-time delivery” requires advanced planning and communication of the submission with the FDA. This is important so that the FDA has adequate time prior to submission to identify the best reviewer(s) for the submission. The completeness of the submission should be 100% of a self-survey, SmartForm or checklist is used to prepare the submission. The primary metrics for the reviewer would be on-time completion of the review and accuracy of the review.  The FDA already has target turn-around timescales for decisions (i.e. – 90 days), but there are different phases of review and multiple people the are involved in the reviews. Therefore, the measurement of reviewer time should be more granular. The accuracy of the reviewers should be validated by requiring all deficiencies to be re-evaluated by a peer or superior prior to involving the company. Submission sections without any findings should also be reviewed on a sampling basis as a double check. Over time, the FDA should be able to use these scorecards to match up a reviewer with a submitter. It is critical that at least one of the parties is experienced so we don’ t have the “blind leading the blind.” For those that are offended by the concept of a required second reviewer–get over it. Radiologists are periodically graded with images that are “red herrings.”

Modular Submissions

My 3rd suggestion is to consider adopting some of the pre-market approval (PMA) processes for the 510(k) process. In particular pre-IDE meetings and modular submissions seam to be logical process improvements. There is typically one component of the submission that is a little behind the rest and holding up a submission. Under the current system, nothing is submitted or reviewed for a 510(k) unless it is complete. However, it would enable companies to get new and improved products to market faster if submissions were modular. Validation such as shelf-life and sterilization validation is rarely the cause for an “Not Substantially Equivalent” (NSE) letter, but these tests are routinely the last few reports completed for a submission. Adopting a modular submission process for 510(k) would allow companies to submit sections of the submission as they are completed. This modular approach would alleviate the time pressure on both sides, and this proposed change should result in earlier product launch dates for industry. The other component of this process is the pre-IDE Meeting. Prior to initiating a clinical study, companies will submit a plan for the study to the FDA. The intent is to obtain agreement on the validation testing that will be performed by the company–including the number of patients and the design of the Clinical. These meetings would also be valuable for 510(k) submissions where the company and the FDA need a forum to discuss what verification and validation testing will be required–especially for mixed-predicate devices and devices that are significantly different from a predicate device.

What do you think about these proposed changes to the 510(k) process?

Please share your own ideas for improving the 510(k) process–including any comments regarding the FDA‘s plans for change.

How to Train an Auditor on the Process Approach

In Audit Schedule, Internal Auditing on June 8, 2012 at 5:53 am

Country music fans are loyal blog readers too.

            I have been reviewing the trends for how people find my website, and a large number of you appear to be very interested in my auditing schedules and other audit-related topics. Therefore, this week’s blog is dedicated to training auditors on the process approach.

First, the process approach is just a different way of organizing audits. Instead of auditing by clause, or by procedure, instead you audit each process. Typical processes include:

  1. Design & Development
  2. Purchasing
  3. Incoming inspection
  4. Assembly
  5. Final Inspection
  6. Packaging
  7. Sterilization
  8. Customer Service
  9. Shipping
  10. Management Review
  11. CAPA
  12. Internal Auditing

There are two reasons why the process approach is recommended. First, the process approach identifies linkages between processes as inputs and outputs. Therefore, if there is a problem with communication between departments the process approach will catch it. If only a procedural audit is performed, the lack of communication to the next process is often overlooked. Second, the process approach is a more efficient way to cover all the clauses of the ISO Standard than auditing each clause (i.e. – the element approach).

My rationale for the claim of greater efficiency is simple: there are 19 required procedures in the ISO 13485 Standard, but there are only 12 processes identified above. The “missing” procedures are actually incorporated into each process audit. For example, each process audit requires a review of records as input and outputs. In addition, training records should be sampled for each employee interviewed during an audit. Finally, nonconforming materials can be identified and sampled at incoming inspection, in assembly processes, during final inspection, during packaging, and even during shipment.

The tool that BSI uses to teach the process approach is the “Turtle Diagram”. The following picture illustrates where the name came from.

Illustration of the Process Approach

Process Auditing – “Turtle Diagram”


The first skill to teach a new auditor is the interview. Each process audit should begin with an interview of the process owner. The process owner and the name of the process are typically documented in the center of the turtle diagram. Next most auditors will ask, “Do you have a procedure for ‘x process’?” This is a weak auditing technique, because it is an “closed-ended” or yes/no. This type of question does little to help the auditor gather objective evidence. Therefore I prefer to start with the question, “Could you please describe the process?” This should give you a general overview of the process if you are unfamiliar with it.

After getting a general overview of the process, I like to ask the question: “How do you know how to start the process.” For example, inspectors know that there is material for incoming inspection, because raw materials are in the quarantine area. I have seen visual systems, electronic and paper-based systems for notifying QC inspectors of product to inspect. If there is a record indicating that material needs to be inspected—that is the ideal scenario. A follow-up question is, “What are the outputs of the inspection process?” Once again, the auditor should be looking for paperwork. Sampling these records and other supporting records is how the process approach addresses Clause 4.2.4—control of records.

The next step of the process approach is to “determine what resources are used by incoming inspection.” This includes gages used for measurement, cleanliness of the work environment, etc. This portion of the process approach is where an auditor can review calibration, gowning procedures, and software validation. After “With What Resources,” the auditor then needs to identify all the incoming inspectors on all shifts. From this list the auditor should select people to interview and follow-up with a request for training records.

The sixth step of the process is to request procedures and forms. Many auditors believe that they need to read the procedure. However, if a company has long procedures this could potentially waste valuable time. Instead, I like to ask the inspector to show me where I can find various regulatory requirements in the procedures. This approach has the added benefit of forcing the inspector to demonstrate they are trained in the procedures—a more effective assessment of competency than reviewing a training record.

The seventh and final step of the turtle diagram seems to challenge process owners the most. This is where the auditor should be looking for department Quality Objectives and assessing if the department objectives are linked with company Quality Objectives. Manufacturing often measures first pass yield and reject rates, but every process can be measured. If the process owner doesn’t measure performance, how does the process owner know that all the required work is getting done? The seventh step also is where the auditor can sample and review monitoring and measurement of processes, and the trend analysis can be verified to be an input into the CAPA process.

In my brief description of the process approach I used the incoming inspection process. I typically choose this process for training new auditors, because it is a process that is quite similar in almost every company and it is easy to understand. More importantly, however, the incoming inspection process does a great job of covering more clauses of the Standard than most audits. Therefore, new auditors get a great appreciation for how almost all the clauses can be addressed in one process audit.

If you have questions, or you would like a copy of the turtle diagram I use for documentation of audits, please submit a request on my website contact us page.

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