Would you classify this as a concession?

k3nny

Periodic Visitor
#1
Here is my situation -

I am with a medical device manufacturer. However, we have products that are not medical devices. My question is with these items.

1. Recently through internal audits we realized that we are performing inspections that are not adding value, but rather have always been done this way (I know - you've heard it before). The product has over 300 SKU's, but they all require this activity.

2. In my investigation, we have not had any customer issues over the last 18 months - probably longer. No internal non-conformances either.

3. This activity requires significant QM manpower.

I am interested in eliminating this action, as based on my extensive evaluation it is not adding value.

If I were to issue a concession (temporary) for removing this requirement with a plan of action for doc updates, training, system mods. Would you consider this a low risk approach?
:thanx:
 
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Al Rosen

Staff member
Super Moderator
#2
Here is my situation -

I am with a medical device manufacturer. However, we have products that are not medical devices. My question is with these items.

1. Recently through internal audits we realized that we are performing inspections that are not adding value, but rather have always been done this way (I know - you've heard it before). The product has over 300 SKU's, but they all require this activity.

2. In my investigation, we have not had any customer issues over the last 18 months - probably longer. No internal non-conformances either.

3. This activity requires significant QM manpower.

I am interested in eliminating this action, as based on my extensive evaluation it is not adding value.

If I were to issue a concession (temporary) for removing this requirement with a plan of action for doc updates, training, system mods. Would you consider this a low risk approach?
:thanx:
What you have described is not a concession, but reduced inspection based on history. If you do not have a regulatory or customer driven requirement, you can do what you have described as long as you have provided for this within your quality system.

BTW, a concession would be your customer agreeing to accept product that did not meet a requirement.
 
D

David DeLong

#3
Internal Auditors perform audits for compliance to recognized systems in your company as they are now. If you see possibilities for system improvements, note it for the audit review and one could bring up the topic for discussion. One cannot find a discrepancy in a system/process if it is in compliance.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
From what you've described it sounds like acceptable risk.

Inspections should be what is appropriate for the product and customer's wishes. If I manufactured rocket ships and tire irons, I sure wouldn't put the tire irons through the same QA rigor as the rocket ships. I know that's a simplistic example, but here's the premise: base your inspections on:

Product specifications
reliability needs
customer requirements (regulators are customers too)
opportunties for errors needing to be caught
cost of getting it wrong
analysis of prior inspections

There may be more, but you get the idea I hope. Don't use bureaucracy (so?) or "Because I said so!" to design your inspection strategy. Design it according to rational facts.
 

Jim Wynne

Staff member
Admin
#5
What you have described is not a concession, but reduced inspection based on history. If you do not have a regulatory or customer driven requirement, you can do what you have described as long as you have provided for this within your quality system.

BTW, a concession would be your customer agreeing to accept product that did not meet a requirement.
I'm largely ignorant of the medical stuff, so I'm wondering if this is akin to a TS16949 situation where a company has automotive and non-automotive products. The OP says that the product in question isn't a medical device, so do the medical-device requirements even apply? In other words, would a 13485 registration scope apply to non-medical devices made in the same plant as applicable devices?
 

Al Rosen

Staff member
Super Moderator
#6
I'm largely ignorant of the medical stuff, so I'm wondering if this is akin to a TS16949 situation where a company has automotive and non-automotive products. The OP says that the product in question isn't a medical device, so do the medical-device requirements even apply? In other words, would a 13485 registration scope apply to non-medical devices made in the same plant as applicable devices?
The meddev requirements would not apply as long as you write your procedures to distinguish between the different requirements for the different type of products.
 
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