Machinery Qualification Runoff test

M

mibusha

#1
The new company I work for produces special automated machines, slides, and mold patterns. There is no "20 hour test" done on the patterns. Currently there is no 20 hour test done on the slides. The machinery, of course, gets the test. Has anyone had such a variety of product? How did you differentiate the products in terms of performing the test or not in the procedures and other documents? Or did you simply state in the proceures that patterns do not get a 20 hour test?

Michael
 
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
When you develop your procedures, write them to indicate how you handle the various products. Ours indicate that we perform run-off when required by the customer and contract. It also states that if the customer does not provide specifications for the run-off, we will follow the process in the TE Supplement; otherwise, we do it his way, which is the norm.
 
S

Sean D Bannister

#3
We have briefly discussed this topic before. In fact if you take a look at the thread I posted titled TE-QS9000, I explained how our company tackled this point. i.e. Agreed your product qualification criteria with your customer up front. I think you will find that a majority of your customers may not actually be aware of the TE run-off requirements.
Sean.
 
Thread starter Similar threads Forum Replies Date
P Design FMEA for Industrial Machinery FMEA and Control Plans 3
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
Q Bespoke Machinery Process Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Machinery Directive vs. MDD Comparison Matrix wanted EU Medical Device Regulations 6
N Minimum Design factor for CE Marking for machinery CE Marking (Conformité Européene) / CB Scheme 2
M Sample Technical Construction File for Machinery Directive CE Marking (Conformité Européene) / CB Scheme 6
V Equipment/Machinery Validation in ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 3
B Production Control and Traceability - Manufacturing Fishing Vessel Deck Machinery Manufacturing and Related Processes 6
B Should I include documentation for Machinery that isn't in use? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D CE Marking Modified Machinery CE Marking (Conformité Européene) / CB Scheme 3
R Analysing Scrap from Machinery Statistical Analysis Tools, Techniques and SPC 8
M Is there an expectation to meet harmonised standards of the Machinery Directive? EU Medical Device Regulations 7
T Packaging Validation - New Machinery - Terminally Sterilized Medical Devices Qualification and Validation (including 21 CFR Part 11) 7
N Machinery FMEA (MFMEA) Information FMEA and Control Plans 8
J CE Mark - Technical File Help - Machinery Directive 98/37/ec CE Marking (Conformité Européene) / CB Scheme 1
B Machinery FMEA Handbook in electronic format FMEA and Control Plans 5
R Work Instructions - Processes - Does all machinery need to have work instructions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Recast Machinery Directive (May 2006) Other ISO and International Standards and European Regulations 2
samer Machinery Acceptence Criteria Determination? Chemical Blending (Pharmaceutical Plant) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
Z Audit Check List for Safety Machinery - Conformity with OSHA 1910 General Auditing Discussions 7
apestate What Is A Machinery FMEA (MFMEA)? SAE J1739, Section 5. FMEA and Control Plans 5
D Machinery qualifications runoff requirements QS-9000 - American Automotive Manufacturers Standard 1
D Machinery FMEA (MFMEA) Training for a QS-9000 TE Supplement company Training - Internal, External, Online and Distance Learning 5
C How to develop an Equipment / Machinery FMEA - Remember the key word: Predictive FMEA and Control Plans 7
M How is TPM related to Software Engineering vs. People and Machinery? Preventive Action and Continuous Improvement 5
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
Z Qualification of AzureDevOps in Gxp Qualification and Validation (including 21 CFR Part 11) 12
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 3
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
Similar threads


















































Top Bottom