SBS - The best value in QMS software

Reference Card for Dimensions at QC on the Shop Floor

Q

qasclk

#11
I understand, But a requirement for checking to make sure you're using the current version is a form of document control. In such a case, regardless of how the reminder thing is marked, it's under control.
Some queries, By control, do we have to keep track of how many copies of referemce material are on the line? Must we explicitly note that there is a reference card out there with the information? That sounds like a lot of non value added work. I think if the referenced dimension or parameter is CTQ or a SC, then yes, all must be controlled. If not, I do feel that it is not a requirement

I think of the auditor wants to verify if the reference cards are up to date, the acid test will be to see if all the reference cards are of the same content, and are the same as the referenced WI. Correct? Technically, there is no violations of the requirements
 
Elsmar Forum Sponsor

Mikishots

Trusted Information Resource
#12
I understand, But a requirement for checking to make sure you're using the current version is a form of document control. In such a case, regardless of how the reminder thing is marked, it's under control.
What I'm getting at is the definition of an uncontrollled document. It can be a degree of interpretation, but from my view it's very simple - a controlled document is a document whose revision, location and status is known to the organization (such as Document Control). If an individual makes a copy or takes excerpts from of that controlled document and keeps it for their own use, the organization cannot know that this copy exists; it is termed uncontrolled. When a revision is made, the owner of the uncontrolled document may not know it may no longer be valid.

The organization can understand that it is not always convenient or feasible to reference the controlled copy only (as they are often provided at the points of use electronically). Therefore, copies are often allowed with a strict rule: if you make a copy, it's OK for immediate use, but any subsequent use must be preceded by a check against the controlled copy. I know you understand this, but it's a point I'm trying to make clear.

Checking to make sure you're using the current copy isn't a form of document control, IMO. It's a simple rule that allows you to use an uncontrolled copy.
 

Jim Wynne

Staff member
Admin
#13
<snip>Checking to make sure you're using the current copy isn't a form of document control, IMO. It's a simple rule that allows you to use an uncontrolled copy.
Let see what ISO 9001:2008 (and by extenstion, TS16949) 4.2.3 says on the matter:

A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
(My emphasis)

In the scenario in question, (c), (d) and the first part of (g) have been satisfied, assuming that the OP's organization has addressed these things in their document control procedure. Requiring the operator to verify the revision status the reminder thing against the original document is a method of prevention of unintended use of obsolete documents.

In such a situation, it would be the responsibility of an auditor and not the organization, to demonstrate that the method is not effective.
 

Mikishots

Trusted Information Resource
#14
Alright, I'll concede on this one. The only point I was trying to make is that those cards are a potential source of bigger problems; if they're allowed, there have to be rules regarding verification before use. That procedure that satisfies (g) would need to say "if you print it, you're responsible for checking the currency of it".

"Nobody told me there was a change" is not an acceptable excuse.
 

Jim Wynne

Staff member
Admin
#15
Alright, I'll concede on this one. The only point I was trying to make is that those cards are a potential source of bigger problems; if they're allowed, there have to be rules regarding verification before use. That procedure that satisfies (g) would need to say "if you print it, you're responsible for checking the currency of it".

"Nobody told me there was a change" is not an acceptable excuse.
I agree with you in principle. I have to wonder why if it's a simple thing to check the revision status, it's necessary to have that reminder thing in the first place.
 

Mikishots

Trusted Information Resource
#16
I agree with you in principle. I have to wonder why if it's a simple thing to check the revision status, it's necessary to have that reminder thing in the first place.
I am continually shocked that it's necessary (but I shouldn't be by now). Convenience is a nasty bedfellow.
 
Thread starter Similar threads Forum Replies Date
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 3
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 2
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
A Reference Source for Polarity Symbol Other ISO and International Standards and European Regulations 1
Q Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix Quality Manager and Management Related Issues 3
E Reference Only on Gage or Visual Aid Calibration Frequency (Interval) 4
F Quality Objective Reference Chart Customer Complaints 4
V Good Documentation Practices - FDA Reference US Food and Drug Administration (FDA) 9
M Good reference sites or material to help me brush up quickly on Gage R&R Reliability Analysis - Predictions, Testing and Standards 7
J How does Layout Inspection determine Reference Value? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W Do "Reference Only" documents have to be physically marked/labeled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S ISO 9001 Clauses which reference the 8 Principles of Quality Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Where could I get reference to an OQA Sampling Plan of 1 per 1000 ? Quality Manager and Management Related Issues 4
H Can I get some information... CRM (Certified Reference Materials) General Measurement Device and Calibration Topics 3
B Gage R&R Criteria on page 78 MSA Reference Manual Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
N Client Request for Reference Equipment Calibration Certificate General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom