SBS - The Best Value in QMS software

Control of stock (Off the Shelf) Non-Conforming Material & Product Tags

N

Nmark78

#1
Good Afternoon Everyone,

Thank you for taking the time to read this post.

I have a quick questions regarding control of forms/records. We purchase, in bulk, stock non-conforming tags from an online big box store. The forms are used whenever there is a deviation from process or damage to a part. The tag requires basic information to be filled out including issue, shop #, date, and initials of operator. These forms currently are not controlled with a form number and do not reside in our document control system.

My question is this: does this tag need to controlled? My thought is yes as it is required in our Non-conforming procedure which is part of our quality system.

I'm just looking for some feedback or advice before I do something with the 2000 NCM tags I purchased.

Thank you.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Control of stock Non-conforming tags

In your procedure for control of nonconforming material, specify that the material must be positively identified as nonconforming and that the identification medium should convey information that you think should be given. No need to control the tags so long as they include the required information.
 
V

Vthouta

#3
Few years back, we had an audit observation for the tags that were not controlled. The auditor claimed that these can be used by any one, revised by any one as and asked us to revisit the process. Later, we have customized and created a template for non-conforming information that has controlled number assigned to the template.

It should be controlled as per control of 4.2.3 Control of documents and state in your procedure.

Vik
 
A

Alpine

#4
We use a similar item, our purchasing team order it from the printers. Ours have a document and revision on it and in over 10 years we have never had to update. If we ever do, it will be easy to identify superceded tags from the current revision. Given it will not cause you any major headaches, I say have the document control and consistency across your system:2cents:
 

insect warfare

QA=Question Authority
Trusted Information Resource
#5
Good Afternoon Everyone,

Thank you for taking the time to read this post.

I have a quick questions regarding control of forms/records. We purchase, in bulk, stock non-conforming tags from an online big box store. The forms are used whenever there is a deviation from process or damage to a part. The tag requires basic information to be filled out including issue, shop #, date, and initials of operator. These forms currently are not controlled with a form number and do not reside in our document control system.

My question is this: does this tag need to controlled? My thought is yes as it is required in our Non-conforming procedure which is part of our quality system.

I'm just looking for some feedback or advice before I do something with the 2000 NCM tags I purchased.

Thank you.
Since you are buying pre-made tags online, they should be controlled as an external document per 4.2.3 (f) since those tags were not created internally. As far as putting a control number on the tags themselves, that should not be necessary if you follow 4.2.3 (f) by identifying what the tag is (listing it by name) and controlling its distribution (specifying the method used to distribute the identified tag).

Brian :rolleyes:
 

Jim Wynne

Staff member
Admin
#6
We use a similar item, our purchasing team order it from the printers. Ours have a document and revision on it and in over 10 years we have never had to update. If we ever do, it will be easy to identify superceded tags from the current revision. Given it will not cause you any major headaches, I say have the document control and consistency across your system:2cents:
Since you are buying pre-made tags online, they should be controlled as an external document per 4.2.3 (f) since those tags were not created internally. As far as putting a control number on the tags themselves, that should not be necessary if you follow 4.2.3 (f) by identifying what the tag is (listing it by name) and controlling its distribution (specifying the method used to distribute the identified tag).
This sort of thing will work, but why go to the trouble if it's not necessary? What people try to do is protect themselves against incompetent auditors rather than doing the rational thing and defending it when/if the need arises. There is altogether too much controlling of forms and tags when all that needs to be done is to control the information that must be recorded.
 
Thread starter Similar threads Forum Replies Date
O Inventory control ideas - I have an open stock room with a "sign out" book Manufacturing and Related Processes 9
P Do we need equipment stock control for security company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Storage Managment (Stock Control and Storage) procedure for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 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 5
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
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 8
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom