Reject Tags - red tag is a form and needs to have a part number and revision?

M

MikeC

#1
Reject Tags

We had a consultant helping us get ready for our ISO Registration Audit. He stated in his report that the red tag itself had no part number or revision marking on the red tag form. He stated that the red tag is a form and needs to have a part number and revision. I have been through audits in different companies and I never heard of this requirement. Can anyone tell me if this is true and I need to have the part number and revision?
 
Elsmar Forum Sponsor
C

Craig H.

#2
Q

MikeC said:
We had a consultant helping us get ready for our ISO Registration Audit. He stated in his report that the red tag itself had no part number or revision marking on the red tag form. He stated that the red tag is a form and needs to have a part number and revision. I have been through audits in different companies and I never heard of this requirement. Can anyone tell me if this is true and I need to have the part number and revision?

Mike:

Welcome to the Cove!!!

Do you have unique lot numbers, or some other way to identify the tagged parts?

What we do is use orange marking tape (the kind the surveyors use) to mark a pallet of material when its status is questionable. That triggers a Material Review Report (MRR), which notes the lot number of the material (and the grade, and usually the location, which we can often tell from the lot number, as well). The control of the material is through the orange tape, which is changed to paint (an "X" in both cases, on 2 sides of the pallet, by the way) if it is found that the material is nonconforming.

If you have this type of information (lot, problem descript., etc that we have on the MRR) on your red tag, I can see your auditor's point, however, assuming that the information is needed for final disposition.

There is no specific requirement that I know of for control of red tags, but for some processes I could see where it might be needed.

Hope this helps.

Craig
 

howste

Thaumaturge
Super Moderator
#3
4.2.3 says that documents required by the quality management system shall be controlled. If you specify in your system somewhere that you have to use the tag, then it must be controlled. If your system allows you to use alternative methods to identify the material and record the information on it, then the form doesn't require control.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Deja vu all over again...

I remain of the opinion that forms do not have to be controlled unless they act as a WI. If it is only a piece of paper with convienient places to record data, where does ISO say it must be controlled?

Example:

My WI says record the lot number, date, defect type, and inspectors name on a red tag to be attached to the defective product.

My red tag looks like this (except it red):

Date: _____________

Lot number: ___________

Defect type: _____________

Name: ________________

Why do I need to rev. control this tag? Maybe I want to make the line for defect type 2 lines -- now I need to do a revision for no good reason. No harm can come from this, so why control it?

Auditors, what say ye?
 
#5
MikeC said:
We had a consultant helping us get ready for our ISO Registration Audit. He stated in his report that the red tag itself had no part number or revision marking on the red tag form. He stated that the red tag is a form and needs to have a part number and revision. I have been through audits in different companies and I never heard of this requirement. Can anyone tell me if this is true and I need to have the part number and revision?
I am assuming that your use of the term "part number" would be form number, such as QF 001 (for Quality Form 001). That being the case, the standard says documents have to meet certain requirements. Form numbers and revision dates are not necessarily required. You must identify the documents (the tag can be identified by the name, color, shape or what ever). You must also make sure the revision status of the document is also identified. This can also be through various means.

In my opinion, the form does not need a number and rev level, provided you indicate how you are going to make sure folks know what the form is and you have a way to ensure the folks are using the correct version of the form.
 

Tom W

Living the Dream...
#6
I agree with db a little here :agree: . The only other comment I would make is if you have two red tags in the facility used for two different things - they need to be identified and controlled in a manner that prevents unintended use. Also, IMO if you are using the red tag to record quality information, like the nonconformance of the product of any other information that might be used later during CA then you would want to ensure that the information is correct and that the tag is asking for the correct informantion, thus revision control would assist in this. It is still a mater of getting the individual to record the info correctly on the correct tag.

4.2.4 Control of Records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the Quality Management System. Records shall remian legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

This is the requirement - how you meet it is up to you. However the interpretation of this requirement can be very different from auditor to auditor.
 

CarolX

Super Moderator
Super Moderator
#7
MikeC said:
We had a consultant helping us get ready for our ISO Registration Audit. He stated in his report that the red tag itself had no part number or revision marking on the red tag form. He stated that the red tag is a form and needs to have a part number and revision. I have been through audits in different companies and I never heard of this requirement. Can anyone tell me if this is true and I need to have the part number and revision?
Hello Mike and Welcome to the Cove,

I assume you are using this as a quick ID for non-conforming material. For example - we use red tags when sorting thru large parts to identify between good/bad. We then use a non-conforming material report to detail the problem. What are you using it for? If it is for this purpose, IMHO control is not required. In other words, if it is used only for identification, it does not require control.

CarolX
 
#8
Tom W said:
...if you have two red tags in the facility used for two different things - they need to be identified and controlled in a manner that prevents unintended use.
Very good point. We wouldn't want to use the wrong reg tag now would we? That possibility had not even crossed my mind. Good thinking! :agree:
 

Wes Bucey

Quite Involved in Discussions
#9
db said:
Very good point. We wouldn't want to use the wrong reg tag now would we? That possibility had not even crossed my mind. Good thinking! :agree:
Wow! Talk about separating flyspecks from pepper. The consultant may be a little more anal-retentive than I'm used to, but he is correct and incorrect in the same breath.

The tag, itself, could be termed a form and may need to be identified, but the "control" aspect is a completely different topic.

It seems many of us are making a presumption that further info is completed on the red tag [what info is unimportant for our discussion] and then the nonconforming product is parked in a segregated area until final disposition (pass more intensive inspection, rework, scrap, etc.) I'd probably bet money that's true.

IMO: The document itself (the tag) is merely a label and not a controlled document. The controlled document would be the inspection report, the MREB finding, the traveler, etc. Whatever information is added to the label is really referring to one of those controlled documents. If the tagged object is ultimately disposed of, I'm pretty sure no one reclaims the original red tag as a "record" because it would be obsolete. [once the material is scrapped, it no longer fits the description on the tag. If you add info to the tag, you have violated the concept of not altering or modifying a record.]

If it were my organization, I would have a work instruction that says
"use a red piece of paper or tape on suspect material to add ready visual identification as suspect material. Complete a form which describes the material and suspected material defect in sufficient detail for retrieval and examination by MRB before making a decision on final disposition."

If your organization has a document number and revision level for a blank shipping label (before adding all shipping info), then you probably should have one for your red tags (and green tags for good material.) If not, I can't see any auditor making a valid case for a nonconformity in document control.
 

howste

Thaumaturge
Super Moderator
#10
db said:
...We wouldn't want to use the wrong reg tag now would we?
Yes, I remember a particularly nasty incident a few Decembers ago when all of our Christmas presents were sent to the nonconforming hold area because they had red tags on them... :rolleyes:
 
Thread starter Similar threads Forum Replies Date
S Reject Tags - Plastic reject tags that can be erased and reused Misc. Quality Assurance and Business Systems Related Topics 5
M Accept/Reject (Ac/Re) Numbers (ISO 2859-1) Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
H How to calculate the Lot Reject Rate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T What does the Gage R&R results tell about my Accept/Reject Decisions? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
A Disposition of Reject vs. Scrap Material Nonconformance and Corrective Action 6
K Inspecting a Length of Weld - High Reject Rates Manufacturing and Related Processes 7
O Sampling Plans for a Medical Device - What to use for my Accept and Reject Number? AQL - Acceptable Quality Level 3
R Supplier Quality - What constitutes a Reject? Supplier Quality Assurance and other Supplier Issues 12
J Gage R&R Study by Attribute (ACCEPT-REJECT-INVESTIGATE) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
J Certification Body - Time Frame to Reject an Appeal Registrars and Notified Bodies 4
T How to define c=0 Reject Rates Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
S Is there an Accept/Reject Criteria for 100% Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
C What is a good way to reject job applicants? Career and Occupation Discussions 11
S Calculating an AQL given a sample size, accept/reject numbers, and lot size AQL - Acceptable Quality Level 2
M Confidence Intervals - How we determine the probable reject rate Statistical Analysis Tools, Techniques and SPC 1
I Rejects due to material during processing - is it an in-Process or Material reject? IATF 16949 - Automotive Quality Systems Standard 2
H Source for Quality Assurance Stickers - QC Approved, Reject, Hold, etc. Document Control Systems, Procedures, Forms and Templates 17
L Internal threads - Maximum / Minor accept/reject diameter inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
W Measuring production performance - Defect Detection % vs. Internal Reject Registered Visitor Articles Archive 4
D Lot Reject Rate - The use of ppm vs. % (per cent) Statistical Analysis Tools, Techniques and SPC 17
SteelMaiden Customer Returns/External Reject Rate - Seeking world class performance benchmark ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Reject Rates - Lots and split lots Quality Tools, Improvement and Analysis 3
B Question about AQL - Why did the customer reject our products??? AQL - Acceptable Quality Level 6
L Using Cpk index for Accept / Reject Decisions Capability, Accuracy and Stability - Processes, Machines, etc. 1
S FMEA - Reject a PPAP because the RPN number is not shown? QS-9000 - American Automotive Manufacturers Standard 6
F Country of Origin or Made In Tags - Where a country is a principality EU Medical Device Regulations 11
N Control of stock (Off the Shelf) Non-Conforming Material & Product Tags ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B FDA Requirements for Retaining Non-Conformance Tags (Medical Device Manufacturers) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Requirements for PMA parts for domestic use and 8130-3 Tags Federal Aviation Administration (FAA) Standards and Requirements 2
D Assembly Line Traceability using Green Tags - Conformance with ISO9001 Manufacturing and Related Processes 3
F Calibration Tags - External company applied their tags - Do I need to apply our tags Document Control Systems, Procedures, Forms and Templates 6
A US group implants electronic tags in workers World News 14
apestate Supplier for QC stickers, hold tags, etc. Document Control Systems, Procedures, Forms and Templates 4
M Lack of Training vs. Laziness: Failure to Complete Forms and Tags AFTER Training Training - Internal, External, Online and Distance Learning 68
W Nonconformance ID tags - Seeking universal non-conforming Red Tag - Approx. 4" x 6" Document Control Systems, Procedures, Forms and Templates 3
Wes Bucey RFID (radio frequency identification) Tags - Inventory and WIP Tracking Misc. Quality Assurance and Business Systems Related Topics 19
Marc Europe Adding RFID Tags to Euro Currency World News 3
E Where Can I Buy Two Part Rejection Tags? Nonconformance and Corrective Action 6
J Our tags (that identify the status of parts) and labels do not have a form number Document Control Systems, Procedures, Forms and Templates 3
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
R IATF/IAOB Red Supplier Pilot Program IATF 16949 - Automotive Quality Systems Standard 1
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
P Are red non-conformance bins required anywhere in the ISO or IATF standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O EMC testing under RED and IEC 60601-1-2 CE Marking (Conformité Européene) / CB Scheme 1
C Looking for RED ESD Bags that preferably say NON-CONFORMING Manufacturing and Related Processes 5
R AS9102 - Are FAIs against a Customer Red-Lined Drawings Allowed? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R IEC 60601-1 4th Edition - Is a "Red-line" version available? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Marc Definition RED = Radio Equipment Directive Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Y Can manufacturer select AR for MDD different from AR for RED? EU Medical Device Regulations 5

Similar threads

Top Bottom