Product Recall Query

Hi everyone,

I have a query on the need for a Product Recall Procedure.

Some background:
- I was the Quality Supervisor for a mature ISO 9001 certified Distribution company (distribution of pharmaceuticals, food and general products). When I was there we had a detailed product recall procedure for instances where a suppler recalls a product. there was however never a case where the procedure was used (no recalls). There procedure was audited internally - just surface audit to see if managers knew what to do.

Current:
I'm now implementing ISO 9001 at a dealership and distribution company (vehicles, tractors, equipment, agricultural chemicals and seeds, batteries tyres, lubricants, auto rental, hygienic solutions, office products).

I don't see value in implementing a procedure for product recall. My old boss suggests that I should do one for the recall of vehicles by the manufacturer. But I don't see it as necessary and I can't see a part of the standard that requires it.

What do you guys think? I don't want to have any gaps in my QMS nor do it want to have unnecessary processes documented.

Suraiya

 

I worked for a nation wide used car dealership, Many vehicles have recalls, (just about every vehicle on the road for airbags), We did not personally recall the vehicles, During the sale of the Vehicle we would disclose all recalls on the vehicle current and "closed" ones and showed them how to register their vehicle with the OEM dealer ship to be notified when new recalls would arise. However during the reconditioning process the vehicles with safety related recalls were put into a separate zone and we would send them to the OEM dealer for fixing. It covered our recall process and covered the customer to be educated on recalls, everyone was happy.

 

So with manufacturers recalls, the OEM manufacturer is responsible for fixing the recall, so if you were to purchase your Audi used or from a third party and it had a recall, you would register your vehicle with the local Audi Dealership saying i now own this vehicle (warranties may not transfer depends) and they will fix the recall. I was working at a LARGE nation wide used car company when the "airbag crisis" hit i had 400/800 cars on my lot that i could not make sale able because of the air bag recall (giant pain in my...), i had to schedule with each dealer ship to get them fixed.

 

I was stating that the OEM manufacturer is the one responsible for fixing the recall, It is dealership responsibility to either give the vehicle to the OEM if its safety related (air bags seat belts etc) or if its not safety related the dealer ship is able to sell it but must notify the buyer of the recall. I know this to be true because i experienced it.

 

If I bought a vehicle from your company, then after a couple of years I came to know that such vehicle model have safety issues and the OEM have already done recalls since a year after I bought the vehicle. I would be pissed with your company for not telling me. What if that safety issue occurs while I'm driving the vehicle?

As a distributor/dealer your organization should ensure that the following requirements of the standard are fulfilled:

8.4.2c.1 - The organization shall... take into consideration... the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements
8.5.1h - Controlled conditions shall include, as applicable... the implementation of release, delivery and post-delivery activities
8.5.5b - In determining the extent of post-delivery activities that are required, the organization shall consider... the potential undesired consequences associated with its products and services
8.7.1 - This shall also apply to nonconforming products and services detected after delivery of products... The organization shall deal with nonconforming outputs in one or more of the following ways... return or suspension of provision of products and services... informing the customer​

 

Hi everyone,

Thanks for your feedback.

1. We do not manufacture the vehicles, we are merely the authorized dealers in the country. We only sell NEW vehicles.
2. We do not issue the recalls. it would come from the supplier.

My query relates the extent to which we need to document this system. Does the standard require a procedure? or just retained documented information?

I know 9001:2015, does not require a quality manual. However I have decided to keep it as I see it adding value for me.
Can I simply state in my Quality Manual, under the respective clause, that should a recall arise form our supplier (all our suppliers - vehicles, tractors, chemicals, batteries etc) that our company will communicate such to consumers with guidance from supplier?

Suraiya

 

Thank you, I will do just that and ask the responsible managers to review to ensure everything is captured.

 

I would be careful with saying you will communicate the recall, "we" said we would communicate any current recalls at the time of sale. After the sale it was the responsibility of the purchaser to register their vehicle with the respective OEM and handle their own recalls. IF you say youre going to communicate the recall you might find your company reaching out to everyone you have sold to.
I would recommend you talk about the risks, resources and extent of communicating it to everyone.

 

no one is disagreeing with you....

 

I see your point. I will throw this out to the management team to clarify to extent of our responsibility.