Machinery qualifications runoff requirements

D

dwayne

#1
#1
we are registered to QS9000TE. Does anyone have any input regarding 4.2.4.2 concerning the 20 hour dry run. Do these run-offs have to be a continouous 20 hour run? There has been a recent debate internally, that machines could be shut down during the shift change and started the next morning. Has anyone ran into similar difficulties surrounding the run-off requirements established in 4.2. Any suggestions would be appreciated.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
D

Dan De Yarman

#2
#2
Dwayne,

We have, with acceptance by the Customer, run two 10 hour shifts documenting the all failures and submitted our findings to our Customer. Make sure your procedure states that you runoff the machine "per the contract" or "per the agreement" or something. Then all you have to do is whatever you've agreed to. You MUST have a waiver or another agreement from the Customer in order for this to fulfill the requirements. It is a gray area, but if you document what you're doing when you deviate from the standard and why you are doing it, it will usually satisfy the auditors. Also, it just makes good business sense to do so.

We have three choices for Dry Run at our company. We have "as agreed to" in the contract, quote or whatever. We have a standard 2 hr. Dry Run. And finally we have QS-9000 TE Supplement 20 hr. Dry Run. If you can get the Customer to agree to something less inhibiting than the continuous 20 hr. Dry Run, DO IT! You will save yourself a lot of headaches and your company a lot of money.

Please understand we choose to use this format at our company because we build custom automated industrial equipment. Ususally we build only one or two machines (if we're fortunate) at any given time that are remotely similar to each other.

Does this help?

Dan
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T PFMEA vs MFMEA or DFMEA on equipment/machinery FMEA and Control Plans 19
J Machinery Directive : Emergency stop clause : definition of 'portable' or 'hand-guided' machinery Other ISO and International Standards and European Regulations 0
B Cl. 9.2 - Moving parts - Applicable only to machinery? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
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
Al Rosen 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 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 Machinery Qualification Runoff test QS-9000 - American Automotive Manufacturers Standard 3
M How is TPM related to Software Engineering vs. People and Machinery? Preventive Action and Continuous Improvement 5
A PRRC Qualifications EU Medical Device Regulations 0
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
T MDR Adverse Events Assessments - What qualifications are required? Other Medical Device Regulations World-Wide 3
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M API 6D-2014 24th Ed. Pto 6.10 - Heat Treatment Equipment Qualifications Oil and Gas Industry Standards and Regulations 4
Casana 2nd Party and Internal Auditor Qualifications & Training IATF 16949 - Automotive Quality Systems Standard 13
M CO2 Incubators - Equipment Qualifications in addition to Calibration Qualification and Validation (including 21 CFR Part 11) 5
K SSBB Qualifications and Experience Requirements Professional Certifications and Degrees 2
X Internal Audit Trainer Qualifications Requirements (TS 16949) IATF 16949 - Automotive Quality Systems Standard 7
P What qualifications are required to become an auditor for a CB (BSI, for example)? Career and Occupation Discussions 4
N Improving my Quality Qualifications - What certifications, seminars, classes, etc. Career and Occupation Discussions 2
C Software Planning Tool for Equipment Qualifications, Process Validations Software Quality Assurance 3
F Internal Audit quiz - Auditor Qualifications and Requirements Internal Auditing 34
B Internal Auditor Qualifications - TS 16949 Clause 8.2.2.5 IATF 16949 - Automotive Quality Systems Standard 20
J Where do you define Internal Auditor qualifications? Internal Auditing 9
D Minimum requirements/experience/qualifications to be head of quality Career and Occupation Discussions 6
K Qualifications I need to adhere to for Thread Gage Calibration Calibration Frequency (Interval) 1
D ESD Auditor - Qualifications Various Other Specifications, Standards, and related Requirements 2
K CQE/SSGB Qualifications and Requirements Professional Certifications and Degrees 5
D Retrospective (Retroactive) Supplier Qualifications Supplier Quality Assurance and other Supplier Issues 5

Similar threads

Top Bottom