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pFMEA, an Introductory Look.

This article is an introductory look at what exactly is a pFMEA or Process Failure Modes and Effects Analysis, and some ideas on how to use them as part of a living breathing risk management system.

RPN Scoring Table pFMEA, an Introductory Look.

I recently had someone ask for help understanding the
process FMEA a little better. I can’t blame them because I was lost the first
time I tried to fill out a form for one. It can be a confusing and overwhelming
if you have never seen one before.

First things first, what is a pFMEA-

FMEA= Failure Modes and Effects Analysis

A lower-case letter will come before the FMEA, and that denotes the ‘what’, of what the failure is that is being analyzed. A pFMEA will often be examining process failures where a dFMEA might evaluate design failures. (dFMEA’s can be confusing as well, Robert Packard created a training on how to document risk management activities without using one in his Death of the dFMEA Webinar)

Some systems capitalize all the letters. Some capitalize
none. That is not what is important as long as it is consistent throughout your
system. Everyone should be able to easily understand that whatever variation of
pfmea is used it means “process failure modes and effects analysis”. 

What does a pFMEA do?-

A pFMEA will break down your manufacturing process into its individual steps and methodically examine them for potential risks or failures. For companies that utilize our Turn-Key Quality Management System, FRM-025 process Failure Modes and Effects Analysis can be used as a template.

For this example, we will look at receiving inspection of
injection molded casing parts for a medical device. This receiving inspection
includes a manual inspection of 10 randomly selected parts out of each delivery
of 100 using an optical overlay.

Process Step-

This area as the section title suggests is the process step. When looking at the process as a whole the pFMEA will break it down into each and every step included in that process. This area is simply that individual step that is going to be examined.

The Process Step, or item function depending on what your form uses for this scenario is going to be part of the random sampling for manual inspection of the received parts using an optical overlay. Our example is going to be the backlighting element of the optical overlay display. The backlighting element will illuminate the inspected part against the template to verify that the part is within specific dimension criteria.

Potential Failure Modes-

A failure mode is a way in which that process step might fail. since it is failure modeS, it needs to be considered that there may be more than one way for the process step to fail. Do not be fooled that because this box on the form has been filled in that the pFMEA will be complete. A thorough examination of all of the possible failures should be investigated.

Our example in this process requires the backlighting element to illuminate a visual template over the parts. The light not illuminating properly is a potential failure mode of this process.

Potential Effects of Failure-

the potential effects of the failure is a look into what the ramifications would be if that failure for that process step actually happened.

In our scenario one of the potential effects of the lighting not functioning properly is that parts outside of the designated sizing acceptance criteria may be accepted rather than rejected as non-conforming parts.

S (Severity)-

The next area is the first area that requires an estimated grading of the failure. That is ‘Severity’ which is abbreviated as S. There is a scale provided in the ratings section of FRM-025 that outlines the numbering system that Medical Device Academy uses.

Below is a snippet of the rating scale used, this is included with purchase of SYS-010 Risk Management Procedure.

Severity (S)
Severity of the effect Scale Definition
Business Risk 0 No potential harm to patient or user
Superficial 2 Little potential for harm to patient or user

In this case our example is using molded plastic pieces of the outside casing of a medical device. Pieces that are too large or too small will not fit when making the final assembly of the device. These plastic pieces do not happen to be patient contacting, and do not affect the function of the device.

The evaluation of this failure is determined to have no
potential affect on patient safety or increase any potential for risk of harm,
therefore the severity is assigned as a ‘business risk’ meaning that it bears
no risk for the user or the patient. This makes the Severity Score 0.

Causes of Failure-

This column is exactly that. What might cause this identified failure to happen? In our example might be the light bulbs in the overlay machine may slowly burn out over time with use. This burnout causes the potential failure.

If the bulb is expected to only have a lifetime of 100 hours,
then the more hours the bulb is used the more dim the light may become. A
slowly dimming light decreases the sharpness of the overlay template and our
parts that are supposed to have a + or – size criteria of 10% now have a fuzzy
template that in reality changes the overlay to show closer to + or – 13%. Now
parts that are too small or too large may be accepted.

O (Occurrence/Probability)-

This grading criteria is also found in the Ratings section
of FRM-025. This is how often the failure is expected to occur. How often will
the lighting element of our optical overlay fail to function in the appropriate
manner for this cause?

Hopefully not very often. In fact, regularly scheduled
maintenance and calibration of the overlay machine could prevent this from ever
happening in the best-case scenario. Our evaluations determine that the
probability of this happening is low. However, since we cannot be certain it
will never happen the potential for this risk exists and makes the Occurrence
score a 4.

Current Process Controls-

What is currently being done to control this risk? Our
example uses regularly scheduled maintenance and calibration to prevent bulb
burnout effecting the overlay.

D (Detectabiliy)-

Our current process is based off of routine maintenance and
visual inspection. This means that the bulb burnout is something that is
visually inspected for and visual inspections for detectability on the rating
scale are graded as 8. This chart is found in the Ratings Section of FRM-025.

RPN (Risk Priority Number)-

This is a number that is found by multiplying the Severity,
by the Probability, by the Detectability. In our example the numbers RPN
is  0X4X8=32 for an RPN of 32 which is
considered LOW.

pFMEA math-

Below is a short video explaining the math behind calculating the Risk Priority Number

https://www.youtube.com/watch?v=OWfyHyx-zhI&feature=youtu.be

Recommended Actions-

What if anything can be done to improve this process? In our
example a recommended action may be to transfer from visual only inspections to
verification of light output by meter. This makes the Detectability of the
failure measurable by meter or gage which is a detectability score of 4.

This changes the RPN now to 0X4X4=16

The pFMEA shouldn’t be a solo thing-

If it can be avoided this type of analyisis should be done by a multidisciplinary team. Sometimes in smaller companies people end up having to wear more than one hat. There are many entrepreneurs that have to function as the CEO/CFO/Design Engineer/RA/QA manager.

Ideally a team approach should be used if feasable. Have the management level staff who have ownership of the processes participating in this analysis. They should know the process more intimately than anyone else in the company and should have more insight into the possible failure modes of the processes as they have likely seen them first hand. They are also the type of employee who would know the types of recomended actions to control the risk of those failures as well.

The pFMEA should also be a living document-

As new failure modes are discovered they should be added to your pFMEA. A new failure mode might be discovered through a CAPA because the process had an actual failure that was not originally analyzed. Take an instance like that as an opportunity for improvement and to update your pFMEA as part of a living breathing risk management system. Also use this as a time to re-brainstorm potentially similar failure modes that may not have been considered previously so that they can be controlled before they happen.

If you took the time to watch the video above it is also mentioned that in some instances the very first FMEA must be based off of estimates because there is no data. Managers, and engineers may be forced to estimate the probability of occurence. If that is the case the FMEA should be updated in the future to adjust the (O) score to reflect what is occuring in actuality based off of real data and not the theoretical data that was used for the initial estimate.

Posted in: Process Validation, Quality Management System, Risk Management

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What is a Gap Analysis?

This article describes what a gap analysis is in the context of managing your quality system when standards and regulations are updated.

Compliance Assessment Gap Analysis Picture 1024x683 What is a Gap Analysis?
Compliance Assessment/Gap Analysis

What is a Gap Analysis? An introductory look.

Well, that depends on the context. The dictionary definition is “A technique that businesses use to determine what steps need to be taken in order to move from its current state to its desired, future state. Also called need-gap analysis, needs analysis, and needs assessment.” (http://www.businessdictionary.com/definition/gap-analysis.html). 

For the most part this is correct, but we need to tweak it just a little bit to fit better into our regulatory affairs niche, specifically medical device manufacturers. A gap Analysis for a financial investment, or an advertising firm will be very different than one for a medical device distributor. It might even be better served to be called a Compliance Assessment/Gap Analysis, but I am sure someone else has thought of that long before me.

For our purposes the Gap Analysis is formal comparative review of an internal process or procedure against a standard, good practice, law, regulation, etc. This blog article will be an introductory look into that process.

What are the two BIG goals of a Gap Analysis?

It sounds like a simple exercise, but the Gap Analysis or GA for short, can have two very different but complimentary functions. Rather than simply hunting for areas of non-compliance the first goal is to find and demonstrate areas of compliance. 

The second more obvious goal is to find the gaps between the process and the regulatory requirements they are being compared against. 

Why is demonstrating compliance important?

Because this is a formal documented review, a Gap Analysis provides documentation in a traceable manner of meeting the requirements that have been laid out. That traceability is important because it allows anyone to read the report, see the requirement and locate the area of the procedure that demonstrates conformity with that requirement. 

The report itself is an objective tool, not something that is meant to be a witch hunt. The Gap Analysis will compare document contents. If you want to verify that the entire process is fully compliant you will need to dig deeper and observe if the activities laid out within the procedure are being performed per the procedure instructions. It is possible to draft procedures that are compliant with text requirements but non-compliant in the manner that the actions are actually being performed and documented.

What about gaps?

The gaps, or areas of non-compliance highlight opportunities for improvement, if there are any. A Gap Assessment may not find any gaps and present a report that clearly and neatly outlines and explains how each regulatory requirement is being met. 

If there are any gaps identified that does not mean that there is cause for concern. This should be viewed rather as an opportunity for improvement. Standards and procedures change over time and it is natural that procedures and processes will have to change with them.

In fact, the very act of the Gap Analysis shows that there is a documented effort towards continual improvement as long as the gaps are addressed. 

Addressing the Gaps

The report is ideally the first and last step and you have a wonderful piece of paper to show that someone checked, and all of the required areas are being met. However, this is not always the case. When there are gaps, they must be filled.

Addressing a gap should happen in a traceable manner, one that shows it was identified, acknowledged and then how it was fixed. Something that might be addressed through a CAPA process, but that is a topic for a different time. 

In Closing

The Compliance Assessment/Gap Analysis is a singular tool used in the overall maintenance of a quality system. Its actions and performance are similar to a simplified type of audit, but the Gap Analysis itself is not going to replace your regularly scheduled audit activities. However, it will help you monitor and keep your fingers on the overall pulse of your quality system. This is also especially helpful in situations where standards and regulations are updated, and your quality system needs to be evaluated and updated accordingly.

For more in-depth education in specialized areas of assessment look into our training on Technical File Auditing for MDR compliance against Regulation (EU) 2017/745 at the link below.

Technical File Auditing for MDR Compliance

Posted in: Quality Management System

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Third party review of 510(k) submissions – When it makes sense and which third party to choose?

third party review Third party review of 510(k) submissions – When it makes sense and which third party to choose?

What is a Third Party Review?

A third party review is the review of a 510(k) that has been submitted directly to a third party rather than the FDA themselves. Back in 1997 as part of the FDA Modernization Act  or FDAMA the ‘Accredited Persons Program’ was created. This allowed the FDA to accredit persons, or ‘third parties’ to conduct the primary review of certain 510(k) submissions. One of the goals of this program was to be able to make the submission and review process faster and more efficient.

The third party review is not a full alternative to submitting a 510(k) to the FDA. Third parties are authorized by the FDA to conduct the primary review of specific types of devices only. Only certain devices are eligible for third party review. The FDA keeps a database of those devices here in one of their medical devices databases (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm).

The use of a third party review also does not bypass the FDA. The third party is only conducting the primary review of the 510(k) and then forwarding the submission, the review of the submission and the post review recomendation to the FDA. The FDA then has a 30 day timeline to issue a final determination of the submission.

How many 510(k) submissions use a third party review?

In 2016, I did an analysis of 510(k) submissions reviewed by the general and plastic surgery panel. I reviewed submissions that received clearance between January 1, 2015 and August 10, 2016. Of the 690 510(k) clearances that were issued by the panel, only nine (9) were submitted for third party review. Although third party reviewers were responsible for only 1.3% of the submissions I reviewed, there are other device classifications with higher percentages of reviews being conducted by third party reviewers. In fact, there were a total of 114 submissions that were issued 510(k) clearance through a third party review process during that period.

For this article, I reviewed the 3,023 510(k) clearances that were issued in the past 12 months (i.e., May 23, 2016 through May 23, 2017). Only 75 of the 510(k) submissions issued (2.5%) were submitted for third party review. Of these 75 submissions, the average review time by the FDA (after the third party review is completed) was 46 days. Since the average review time for the FDA of a traditional 510(k) is 183 days (based upon my data analysis from 2016), third party review can potentially reduce your 510(k) clearance timeline by months.

Why do only 2.5% of 510(k) submitters utilize a third party review?

Originally, my theory was that only a limited number product classification codes are eligible for third party review. The FDA is trying to expand the third party review program, but 44% of third party reviews are for the radiology panel. Another 13% were for the general hospital panel, and 13% more of the reviews were for the cardiovascular panel. Finally, less than 7% were reviewed for the dental panel. The remaining 17 submissions were reviewed for other panels. A closer look at the product classification codes shows that there are only a few product codes within these panels that are being reviewed by third parties.

I also had a second theory for why so few submitters are using third parties. As I reviewed the actual 510(k) summaries for these 75 submissions, I noticed there were only four (4) companies listed as third party reviewers in the last 12 months:

  1. Regulatory Technology Services, LLC (http://www.markjob.com/) = 56 submissions
  2. Third Party Review Group, LLC (http://www.fdathirdpartyreview.com/) = 15 submissions
  3. TUV SUD America, Inc. (http://www.tuv-sud-america.com) = 3 submissions
  4. Center for Measurement Standards of Industrial in Taiwan = 1 submission

2018 Updated- FDA’s reporting of the first three quarters of 2018

Compared with the above information the first three quarter reportings for 2018 list a total of more third party reviewers. Currently in the quarterly reports from the FDA there are the following 3rd party reviewers:

  1. AABB = 5 or less
  2. Center for Measurement Standards of Industrial (CMSI) = 5 or less
  3. New York State Department of Health (NYSDOH) = 5 or less
  4. Nordic Institute of Dental Materials (NIOM) = 5 or less
  5. Regulatory Technology Services, LLC. (RTS) = 36
  6. Third Party Review Group, LLC. (TPRG) = 13
  7. TUV SUD America, INC. (TUV) = 5 or less

The FDA keeps an up to list of approved third party reviewers under the Medical Devices Databases. Titled Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997- (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/Accredit.CFM?party_key=8).

As of Quarter Three there have been a total of 53  Third Party 510(k) Submissions Accepted. A majority of these completed by Regulatory Technology Services, LLC, and Third Party Review Group, LLC (TPRG). 36, and 13 respectively. All of the others have 5 or less but these numbers may increase once the fourth quarter report is released.

When should you chose a third party review instead of submitting directly to the FDA?

Always check the 510(k) database to see if third party reviewers were used for your product’s classification code. Ideally, a third party reviewer has been involved in a device that is in the same product classification and possibly that device would be a suitable predicate for you to select for your 510(k) submission. If your search yields no results, your device may not be eligible for a third party review. However, you can always contact one of the four third party reviewers listed above.

In general, the third party review process is an excellent way to shorten your 510(k) clearance timeline by months. The cost is significantly more than the FDA user fee. However, faster time to market is almost always worth the increased fee. Therefore, if a third party review is available I recommend taking advantage of this option.

Do you need help?

Medical Device Academy offers a regulatory pathway analysis service for $1,500. For those of you that are only interested in the US market, rather than including the EU and Canada, the cost for this service is only $750. Do you need help identifying the product classification for your device, determining the required performance testing and selecting a predicate device? We can do this for you in one week or less. Do you need an expedited review? We can also determine if your product is eligible for third party review and obtain a quote for you.

Posted in: 510(k)

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