Complaint Handling Responsibilities for a Design Partner - ISO 13485

[mwb0585]

First, thank you all in advance for your help.

I work for a company that helps design medical devices. Our customers are the legal manufacturers, and hold all the intellectual property. At the end of a particular project, our customer takes full ownership of the design. We have an ISO 13485 certificate with a scope that allows for ‘provision of design and development services of medical devices.’

So my question is this: with the new ISO 13485:2016 standard, are we required to establish a complaint handling system?

My belief is no. Our customers are responsible for documenting customer complaints related to the medical devices. My company does not produce medical devices, and does not provide any service that affects the performance of such medical devices.

We have been asked "What if a customer alleges deficiencies related to a design you contributed to?” Our response has been "If the customer issues us a formal corrective action request, we will initiate a CAPA, otherwise, any action will be at the discretion of management. The alleged deficiency does not meet the definition of complaint, and is not subject to the requirements of complaint handling."

When we update our certification to 13485:2016, we are considering claiming that Clause 8.2.2 is not applicable, because we do not produce medical devices, or provide any service that affects the performance of such medical devices.

Do you agree? What are your thoughts? Are there any holes in this logic?

 

[Ronen E]

When we update our certification to 13485:2016, we are considering claiming that Clause 8.2.2 is not applicable, because we do not produce medical devices, or provide any service that affects the performance of such medical devices.

Design and development don't affect the performance of the designed/developed device? :mg:

 

[somashekar]

First, thank you all in advance for your help.

I work for a company that helps design medical devices. Our customers are the legal manufacturers, and hold all the intellectual property. At the end of a particular project, our customer takes full ownership of the design. We have an ISO 13485 certificate with a scope that allows for ‘provision of design and development services of medical devices.’

So my question is this: with the new ISO 13485:2016 standard, are we required to establish a complaint handling system?

My belief is no. Our customers are responsible for documenting customer complaints related to the medical devices. My company does not produce medical devices, and does not provide any service that affects the performance of such medical devices.

We have been asked "What if a customer alleges deficiencies related to a design you contributed to?” Our response has been "If the customer issues us a formal corrective action request, we will initiate a CAPA, otherwise, any action will be at the discretion of management. The alleged deficiency does not meet the definition of complaint, and is not subject to the requirements of complaint handling."

When we update our certification to 13485:2016, we are considering claiming that Clause 8.2.2 is not applicable, because we do not produce medical devices, or provide any service that affects the performance of such medical devices.

Do you agree? What are your thoughts? Are there any holes in this logic?

Your customer can complain back on anything between your business transaction, including about your outputs., and your system must be able to handle this.
A complaint from customer about his complaint related to the device safety, performance or effectiveness, directed to you is nothing but a design change project.

 

[yodon]

You say you're registered to 13485 as a service provider. YOUR product is the service. Your customers certainly can complain about your service. The standard says that you have to have complaint handling procedures in accordance with applicable regulatory requirements. You don't have any applicable regulatory requirements but the standard goes on to describe the minimum requirements for complaint handling procedures.

We're in the same boat (service provider) and this approach seems to work. Besides, it makes reasonable business sense to capture any customer complaints, review them to see if your processes can be improved, etc. All part of continual improvement, right?

 

[Edward Reesor]

As a medical device company who relies on a primary design partner, we would handle any complaints generated by the distributors and end users, however we may have to issue a complaint if the product you supplied (e.g. a design change as a result of a voluntary modification or a CAPA) was not what we asked for or was late, etc., etc.

To not have a complaint handling policy of some sort would look like you never get complaints of any kind. One of the traps in this whole regulatory game is that we tend to focus on our primary product when the NB audits will include all aspects of the organization. For example, our devices are single use, disposable medical devices. We used to say that there was no software involved in the product itself until we were reminded that we use Microsoft Office to do a lot of our admin stuff. Years ago, Excel had a bug where the column sums were bad and the numbers literally didn't add up. That would have the potential of creating errors in our product tracking in the event of a recall. So now we expanded our risk analysis to include software of any kind.

 

[mwb0585]

Your customer can complain back on anything between your business transaction...

This is one of the areas we find ourselves scratching our heads. Here are two scenarios: (1) A customer says our design functions great, but that the project ended up costing more than they originally expected, (2) A customer tells us that one of our designs has reliability issues once it is manufactured. The first is related to our "business" and the second is related to our design. Are both of these situations where formally documenting a complaint is required? Situation two seems obvious, but we are having disagreements as to whether the first should be treated in a similar manner.

 

[Edward Reesor]

Although this may not be part of 13485 per se, as part of the MDSAP auditing program, it was suggested that we have a dedicated section in our internal audit and management review to discuss and make a decision on each critical supplier, using any issues we may have had in the previous year (including value for money metrics, delivery times, customer service, etc.). This would include any complaints that would have been issued toward their work. And although we immediately think of the designers or contract manufactures for smaller components, it is expected to include local printers of our brochures or business cards.

It wouldn't hurt to have the complaints handling policy in place and then as part of your own internal audit, mention that there were no complaints generated in that respect. We have very few complaints, however we have to have a very robust process in place in case a simple inquiry about a product later reveals something more significant going on with our product.

 

[Ronen E]

A customer says our design functions great, but that the project ended up costing more than they originally expected

The flip side of this situation is a project ending on-budget but delivering a not-so-great design. If costing/budgeting vs. scope / design input / design output are deficient in some way it is certainly an important aspect of your service's quality, which is better addressed before it results in deficiencies in deliverables.

 

[somashekar]

This is one of the areas we find ourselves scratching our heads. Here are two scenarios: (1) A customer says our design functions great, but that the project ended up costing more than they originally expected, (2) A customer tells us that one of our designs has reliability issues once it is manufactured. The first is related to our "business" and the second is related to our design. Are both of these situations where formally documenting a complaint is required? Situation two seems obvious, but we are having disagreements as to whether the first should be treated in a similar manner.

Freeze your design inputs dear sir .. Expected lifetime of the device and the BOM cost are something you have to decide and agree with your customer upfront.

 

[yodon]

This is one of the areas we find ourselves scratching our heads. Here are two scenarios: (1) A customer says our design functions great, but that the project ended up costing more than they originally expected,

This is something we look at quite closely. There are at least several angles to consider. Was this a "surprise" to the customer that the cost was more than expected? If so, why wasn't this communicated earlier and properly coordinated. Second, why did it cost more? Were requirements late in being established? There are a lot of things that could be considered. We've instituted a number of improvements just on complaints like this. (So, yes, we documented them as complaints).

(2) A customer tells us that one of our designs has reliability issues once it is manufactured.

Yet another opportunity to learn and improve. Did you not consider design for manufacturability? Did you look at anticipated life of parts (within the intended use)? Did you consider likelihood of parts obsolescence?

It's up to you to decide what to put into the complaint system but it's been my experience that underneath the surface, there are plenty of things you can do to improve the processes and your customers' experiences (as well as the products).