Quarantine Zone - Control of Nonconforming Product

[Bev D]

certainly the path of least resistance is to add signage and tags. the visible workplace is a foundational element of Lean for a reason so it's not merely about meeting the letter of the law of the standard but what is the best way to meet the intent. There is a bit of 'risk based thinking' that would help. if it's a smallish company, your training is good, your employees are highly motivated and the probability of inadvertently shipping non-conforming material is low due to great testing capability, then you have probably met the intent. On the other hand, if are largish company with poorly motivated employees, your final acceptance tests are sieves then you probably have not met the intent. I am going to assume (since you are ISO900 certified) that you are not in aerospace & defense or other highly regulated industries where the effect of letting non-conforming material out of your control is really bad such that positive traceable controls are required...

a set of questions that comes at the central question from the opposite angle to help frame the discussion: what prevents a 'bad employee' form taking any non-conforming material simply removing the non-conforming label or walking it out of the marked quarantine area and putting it in a shipping box? or selling it on the black market or giving it to your competition? What prevents them from faking the test/inspection data and passing non-conforming material?

 

[RCH2016]

Is it difficult to simply attach signage identifying and declaring the nature of the nonconforming product?

Our method is simpler than that. Our product is stacked ion pallets in 50 pound bags. If a pallert has material that is suspect, we use orange plastic tape (the kind surveyors use - no adhesive) to make an "X" on the side of the pallet. Instant nonconforming product area.

 

[Project Man]

There is a basic principal that shouldn't get lost in dealing with this situation.
The principle is "being able to take credit for what you do". It's sounds like you have a great culture of understanding non-conformance in you facility. The problem is that it doesn't seem to be documented well enough so that the auditor can give you credit for having that great culture. A good auditor won't take your word for it (talk is cheap) but will look for documented evidence.
The Auditor may very well be over reacting but don't automatically place all the blame on a zealous auditor. Review how you communicated, in writing/documentation, this area of concern.

 

[Jen Kirley]

Our method is simpler than that. Our product is stacked ion pallets in 50 pound bags. If a pallert has material that is suspect, we use orange plastic tape (the kind surveyors use - no adhesive) to make an "X" on the side of the pallet. Instant nonconforming product area.

Visual cues are powerful, as BevD has described. If that's your defined process, it works for me. Ideally there is a means to know that Lot XXXXX is nonconforming so it can hopefully be assured against entry into the production stream and its disposition can be traced. How do you do that?

Let us all please keep in mind that CB auditors are tasked with doing what we can to protect the customer's interests. The "shalls" in the standard are a means to that end.

 

[howste]

...our entire front office is considered a "Quarantine Zone" for nonconforming product, received material waiting on inspection, and R&D stuff...

I would have an issue with material in this "Quarantine Zone" not being further identified. How do I know what material is there for R&D, what is new incoming material waiting for inspection, and what is nonconforming? How do I know what is wrong with the nonconforming material?

The standard says:

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

It also says:

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.

How is it identified? It would be a bad day when someone uses nonconforming material or uninspected incoming material for R&D testing. Or when the R&D material is inspected by RI and sent to production... :mg:

 

[Candi1024]

a set of questions that comes at the central question from the opposite angle to help frame the discussion: what prevents a 'bad employee' form taking any non-conforming material simply removing the non-conforming label or walking it out of the marked quarantine area and putting it in a shipping box? or selling it on the black market or giving it to your competition? What prevents them from faking the test/inspection data and passing non-conforming material?

What prevents any employee from doing these things?

ETA: Some companies have gated/locked areas. I do suppose that would help.

 

[Mike S.]

I would have an issue with material in this "Quarantine Zone" not being further identified. How do I know what material is there for R&D, what is new incoming material waiting for inspection, and what is nonconforming? How do I know what is wrong with the nonconforming material?

Howste brings up a great point. You have admittedly mixed material!

And quite often the Devil is in the details. Exactly what was the auditor's nonconformance statement? We are only hearing your side.

 

[RCH2016]

Visual cues are powerful, as BevD has described. If that's your defined process, it works for me. Ideally there is a means to know that Lot XXXXX is nonconforming so it can hopefully be assured against entry into the production stream and its disposition can be traced. How do you do that?

Let us all please keep in mind that CB auditors are tasked with doing what we can to protect the customer's interests. The "shalls" in the standard are a means to that end.

Hi, Jen! Our process is a little different than most. the process flow is sort of like water flowing from one vat to another through hoses. There may be a process inserted into the hoses, and checks are made at verious places in the process, as well as st the beginning and end. The lot numbers are somewhat arbitrary. So, when potentially nonconforming product is detected, it is usually after the product has been packaged (a big vat full of nonconforming product is, thankfully rare, and it is whole 'nuther painful ball of wax). So, usually the nonconfoming product is identified as certain packages within a lot.