SBS - The Best Value in QMS software

Quarantine Zone - Control of Nonconforming Product

T

Tyler C

#1
Quality pros

I am currently going through our Stage 2 audit and the auditor wants to write something up that I disagree with.

He is looking into control of nonconforming product. A little information, our entire front office is considered a "Quarantine Zone" for nonconforming product, received material waiting on inspection, and R&D stuff. We also have things like computers, desks, and other monitors where people work in the front office. Our procedure states "Nonconforming product will be identified by either a "hold" tag or placed in a quarantine zone." So in our front office, we have some product and material that is not tagged.

The auditor wants to write up a nonconformity that we have nonconforming product and computers in the same quarantine zone. He also wants to write up that the front office is not labeled as a quarantine zone. I told him that when we trained the entire company on control of nonconforming product that the quarantine zones were expressed so every single employee was made aware, through training, where these zones were.

I don't see any explicit requirement in the standard that the zone must be labeled and that nonconforming product can't sit on the same desk as a computer for example. However, we did satisfy the standard when we raised awareness through training.

So my question is, do we have any ground to stand on to challenge this nonconformity?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
If he is to write a nonconformity because your offices aren't labeled, it's potentially worth disputing.

That said, what prevents someone from mistakening one of the items stored in the offices and introducing it to the production stream?

Also, which standard are you working to?
 
T

Tyler C

#3
Thanks for your reply Jen. I sometimes forget there are several other standards out there and I need to specify. We are working with ISO 9001:2008.

What prevents someone from introducing them to the product line is training. When we train control of nonconforming product (which is one of our 'core' trainings that we hold ourselves accountable to training within the first 90 days of employment) we specify that the entire front office is a quarantine zone. If someone were to pull something back into production anyway, then that would have to go through final inspection and would be caught there and rejected and returned to the quarantine zone.

Another indicator for all employees, is that if something was pulled from the quarantine zone that shouldn't be, it would not have a traveler with it. If it doesn't have a traveler the employee wouldn't be signed into anything and would bring it to their supervisor who could then stop it from going any further.
 
T

Tyler C

#4
The only other thing I could see him writing this up for would be that the specific quarantine zones are not listed in the procedure, rather that the zones in general are mentioned.

We did this because we have certain product that is too big to bring to the zone, and if it did become nonconforming, we would have to make its current location a temporary quarantine zone. If this was not listed in the procedure but the others were, I feel that would be breaking our own procedure. So we do need this flexibility.
 
Q

qualityfox

#5
In my early years of ISO, I remember requiring that either the product or the storage area needed to be labeled. I don't see that requirement in the 2008 standard. A lot of labeling and documenting has gone away over the years. If you can show that your training was effective, i.e.: any employee asked about product in the front office would say it is in quarantine, then I would say you are meeting the standard. The fact that computers and nonconforming product are on the same desk is irrelevant unless you make computers. I would possibly write an opportunity for improvement stating you should consider listing the quarantine areas in your procedure, but it is not a requirement. You say you have quarantine areas and all your employees know where they are. Standard met.
 
T

Tyler C

#6
Thank you qualityfox. I agree 100%.

I believe I will ask the auditor if this specific requirement is listed in the standard and for him to show me. If he cannot, I will disagree that it is a nonconformity, but agree it is an opportunity for improvement, as you have already stated.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Since 8.3 of ISO 9001:2008 wants a documented procedure defining identification and controls of product not conforming to requirements, what has your organization said it would do?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Is it difficult to simply attach signage identifying and declaring the nature of the nonconforming product?
 

RoxaneB

Super Moderator
Super Moderator
#9
Is it difficult to simply attach signage identifying and declaring the nature of the nonconforming product?
Adding to that, the lack of tagging or identifying raises a few other process questions:

  • What is to prevent good product from inadvertently being relocated to the front office?
  • What identifies bad product while it's still out on the floor? If I'm staring at Part A and Part B, and they look identical yet one of them is bad, how is someone to know which one to bring up to the front office? Joe went on break and ask me to do him a favour.
  • If identical parts, Part A and Part B, were both bad, but one is to be sold at a reduced price, while the other is to be destroyed, how do I know what the fate of Part A is versus the fate of Part B?

From a black-and-white perspective, you may have grounds to fight the finding, but from the intent of the standard, it sounds like there is some good opportunity to improve the process and reduce the risk.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
I'm with RoxaneB. :agree1:

The problem with using training as a control is the need to constantly refresh if material gets moved: "See here everyone, this is nonconforming material. Okay thanks, now let's get back to work." The idea behind identifying nonconforming status is to remove the need for this constant revisitation. Then there's the (6.2.2) requirement to maintain appropriate records of training for building competency in people whose work affects conformity to product requirements... Given all these considerations, there are some among us, including myself, who would wait to hear more if a person was describing the use of training as a control... :cool:

It isn't too soon to start considering how this would work in the 2015 version, which asks for (8.5.1) implementation of actions to prevent human error and (6.1) a risk-based approach to determining controls as well as (8.1e) determining, maintaining and retaining documented information to the extent necessary to demonstrate conformity of products. Isn't that the same thing after all?
:2cents:

I have seen innovative approaches such as moveable crowd control stanchions with plastic yellow chain, and a sign attached. Identification achieved, check, move on.
 
Thread starter Similar threads Forum Replies Date
B Supplier has process to use material in quarantine Nonconformance and Corrective Action 11
D Physical Movement Deterrent for Quarantine of Goods on a Pallet-by-Pallet Basis Nonconformance and Corrective Action 8
P Quarantine/bounded area - Plant manager does not think this is needed Nonconformance and Corrective Action 14
Q Time change via change of Time Zone Qualification and Validation (including 21 CFR Part 11) 3
Marc Twilight Zone - What is your favorite Episode? Coffee Break and Water Cooler Discussions 10
Marc Time Zone - Set your Time Zone Elsmar Xenforo Forum Software Instructions and Help 1
A Legislation Register in Dubai (Free Zone) ISO 14001:2015 Specific Discussions 1
L IEC 60601-1 3rd edition Clause 9.2.2 Trapping Zone (Acceptable Gaps) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
B How to calculate Cpk on Perpendicularity (Cyl Tol Zone at MMC) Capability, Accuracy and Stability - Processes, Machines, etc. 32
G Explanation of Rule of Thumb (10:1) - Tolerance Zone or Digits Number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Rameshwar25 Signal Detection Method Zone Classification Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
J Nadcap HT - Furnace Instrumentation Type - Control Zone definition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Marc 50 years later, 'Twilight Zone' bridges time Coffee Break and Water Cooler Discussions 0
Chennaiite Projected tolerance zone - accounted during measurement or manufacturing? Manufacturing and Related Processes 2
B Opinions on Zone Alarm Internet Security Suite After Work and Weekend Discussion Topics 2
L Helix Zone Technologies - Anyone heard of it? Software for databasing FAI information Quality Assurance and Compliance Software Tools and Solutions 3
J Where Can I Buy Reflow Zone Curtains? Manufacturing and Related Processes 1
F Definition Retention Zone - What exactly are you calling zones of retention? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
D Use Error Risk Controls and Control Verification ISO 14971 - Medical Device Risk Management 6
S Maintenence related action in Control plan FMEA and Control Plans 3
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
R Control Methods in Control Plan FMEA and Control Plans 4
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 11
S TSCA (Toxic Substances Control Act) PIP 3:1 RoHS, REACH, ELV, IMDS and Restricted Substances 0
S Use of Attributes Control Charts Statistical Analysis Tools, Techniques and SPC 1
U Appraiser Out of Control Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
Z AS9100 Control of Nonconforming Outputs - Rework Dispositions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
J Warehouse temperature and humidity control EU Medical Device Regulations 7
Jimmy123 IATF16949 Control Plan FMEA and Control Plans 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 1
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 1
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17

Similar threads

Top Bottom