What are the requirements, including frequency, of Gage R&R

E

Eduardo - 2003

#1
Need you inputs, we had an internal audit to the 4.11 element on QS9000, the internal auditor found that the Gage R & R are not conducted for some equipment since year 2000. We were looking at the QS9000 standard and could not find anything related to the frequency of the gages analysis. So the thechnician did not accepted as a NO conformance because the QS did not mantioned claerly. Can be a NC or Not? he said that he can accepted as observation...........
 
Elsmar Forum Sponsor
A

Atul Khandekar

#2
Eduardo,

I see your question in two parts: R&R and Audit.

You don't do R&R for the auditor. Its the question of how confident you can be about the measurement system - whether is is capable of detecting part variation, special cause of variation etc. This has been discussed several times in the forums. To that extent you should be able to demonstrate that the measurement system has not changed over the last 3 years. (same apparisers, trained appraisers, periodic calibration, no change in methods, no problems with the products checked with this system etc etc). The measurement system usage is another factor. If its used many times every day (eg. calipers, micrometers..) then a period of 3 years between R&R studies does appear to be long.

Audit is conducted against your procedures. What is the R&R frequency as per your procedure? If you have failed to conduct R&R study, then it is an NC. If you don't mention R&R frequency in the procedure, it may be an NC. If the (internal) auditor 'knows' something more than what you are showing him, he can probably make an observation. I am not an expert in auditing, but I'm sure others will chip in with their comments.

Please do a forums search for more inputs on this. Here are a few threads to get you started:
http://Elsmar.com/Forums/showthread.php?t=927
http://Elsmar.com/Forums/showthread.php?t=1073
http://Elsmar.com/Forums/showthread.php?t=3690

-Atul.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
J Requirements for Layered Process Audits including Maintenance, Shipping, Receiving IATF 16949 - Automotive Quality Systems Standard 4
R Labeling, translation requirements including software interface: EU & other markets EU Medical Device Regulations 2
V PPAP Requirements including GMW 3179 Zinc Plating Specification Requirements APQP and PPAP 3
P Can an outside consultant audit all the AS9100 requirements including Internal Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J 7.4.2g ?flow down to the supply chain the applicable requirements including customer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Does anyone have the Ford Supplier Requirements Manual (including Q1)? Customer and Company Specific Requirements 2
M DCX Annual Layout Requirements including Subcomponents Customer and Company Specific Requirements 1
W Statutory and Regulatory requirements - Including Shipping ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Help needed for PPAP submission requirements including contents APQP and PPAP 3
R Flammability requirements for applied parts as per 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 4
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R PPAP Requirements for Tool Repair or Refurbishment APQP and PPAP 5
I France clinical trial requirements EU Medical Device Regulations 1
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
M GP-12 procedure form and requirements Customer and Company Specific Requirements 1
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D Customer Specific Requirements / Customer Requirements for Indirect Customers IATF 16949 - Automotive Quality Systems Standard 10
J Print Requirements Manufacturing and Related Processes 9
S Requirements for Certificate of Destruction for Surgical Instruments Medical Device and FDA Regulations and Standards News 2
R FAI & P.O. Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
B Requirements for LiPo Batteries in the EU ? CE Marking (Conformité Européene) / CB Scheme 7
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Gauge Management - with ambiguous requirements & no support ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4

Similar threads

Top Bottom