Customer Returns Procedure - Seeking Example

[Scoobz]

Our business operates to GMPs for Medicinal and Food Supplement Products. We have within our Quality System, procedures for the return of products from customers.
These procedures document the processes undertaken within the Distribution Centre where the return is physical received and logged back onto our ERP system. Additionally we have procedures for the Quality Assurance processes, which conduct inspection and assessment of the products to determine their fate.
These procedures are predominantly used for returns from retail customers (e.g. supermarkets or pharmacy chains).

We have separate procedures for Customer Complaints (including return of product) and Pharmacovigilance (Adverse Drug Reaction Reporting).

All of the above systems are requirements of Medicinal and Food Laws (not driven by ISO).
The procedures are very beneficial to business processes and tie into the function of our ERP, Product Life-Cycle Management & Issues (Non-Conformance) Management systems.

[pmwong]

pls find an attached example. Hope this sample helps

[kvnchrls]

Hello All,
My question is concerning RMA's. ISO 9001:2001 has several areas where a Procedure for RMA's could apply( Customer Satisfaction 8.2.1), (8.3 Nonconforming Material) perhaps also 7.5.2 for revalidation if a Recalibration of the product needs to take place. And I am sure there are other areas that could apply.

So the question is : Where would be the best place in ISO to address the RMA Procedure, i.e. what discipline or specific area?

Best Regards, Kevin

[Jim Wynne]

In Reply to Parent Post by kvnchrls

Hello All,
So the question is : Where would be the best place in ISO to address the RMA Procedure, i.e. what discipline or specific area?

Where is the ISO document used? There is no "best place in ISO" to put any document. In this case, there isn't even an ISO requirement to have a document. Insofar as the organization of your company's process documentation is concerned, put it where it makes the most sense for you and the people who need to use it.

[kvnchrls]

Thank you Jim for your reply. Our company manufactures a metering device.

Our products are proprietary in nature. Our QMS is designed to accomodate a manufacturing environment.

Although there is no ISO requirement to have a proocedure for RMA's, we thought it prudent to have one since it is a discipline in our organization and needs to be defined and spelled out as to how Customer returns are handled.

[Jim Wynne]

In Reply to Parent Post by kvnchrls

Thank you Jim for your reply. Our company manufactures a metering device.

Our products are proprietary in nature. Our QMS is designed to accomodate a manufacturing environment.

Although there is no ISO requirement to have a proocedure for RMA's, we thought it prudent to have one since it is a discipline in our organization and needs to be defined and spelled out as to how Customer returns are handled.

I didn't mean to suggest that you shouldn't have a procedure. You should have all of the documentation you think you need. I just meant that you don't need to be overly concerned about its relationship to the ISO standard. As you correctly observed earlier, such a process might bear on more than one ISO clause, but what's important is that the process makes sense for you business, and people who need to use the process know how to do it.

[SteelMaiden]

In Reply to Parent Post by kvnchrls

Hello All,
My question is concerning RMA's. ISO 9001:2001 has several areas where a Procedure for RMA's could apply( Customer Satisfaction 8.2.1), (8.3 Nonconforming Material) perhaps also 7.5.2 for revalidation if a Recalibration of the product needs to take place. And I am sure there are other areas that could apply.

So the question is : Where would be the best place in ISO to address the RMA Procedure, i.e. what discipline or specific area?

Best Regards, Kevin

As you have identified, returned material applies in many areas of the standard. If you, because of the way you have implemented your system, need to "place" it against a standard clause, why not assign it to something that makes the most sense to your system. For example - we first identify that there will be returned material during the customer complaint process (and then document what was returned, returned condition, inspection results, etc). Our customer complaint process is documented as a part of corrective and preventive actions. Therefore, our RMA process is also documented as a sub-process of preventive and corrective actions.

Is that what you were looking for? As far as the actual documented procedure, or work instruction, just document what you do, or what you would like to do if you are changing your process.

[Cari Spears]

In Reply to Parent Post by Jim Wynne

I just meant that you don't need to be overly concerned about its relationship to the ISO standard.

In Reply to Parent Post by SteelMaiden

If you, because of the way you have implemented your system, need to "place" it against a standard clause, why not assign it to something that makes the most sense to your system.

Hi, Kevin -

Are you concerned about which ISO clause because your procedures are numbered in accordance with ISO clauses?