一份計量体制調查/稽核
一份計量体制調查/稽核,有興趣的朋友可以試試...(以下是部份內容,總的在附樑中)3)Are gauges and test / inspection equipment, including customer owned gauges and equipment, maintained and adequately stored? (including National standard calibration or traceability)
1 – Deficient
No system for maintainence/storage
2 – Marginal
No tracking with general access; regular maintainence
3 – Acceptable
Documented tracking with general access; regular maintainence
4 – Preferred
Documented tracking with controlled access; regular maintainence
5 - World Class
Automated tracking with controlled access; recurring maintainence
4)Are gauges and test / inspection equipment, including customer owned gauges and equipment, checked by a documented system with a defined GR&R system and are records maintained? Are they identified as to: (a) Item identity / Serial No. (b) Date calibrated
1 – Deficient
No system or > 2 deviations
2 – Marginal
Documented system; < 2 deviations
3 – Acceptable
Documented system; no deviations
4 – Preferred
Documented system; no deviations
5 - World Class
Automated system; no deviations
5)Are calibration settings and adjustments safeguarded to prevent unauthorized adjustments/modifications?
1 – Deficient
No system
2 – Marginal
Documented system; unprotected settings
3 – Acceptable
Documented system; password protected settings
4 – Preferred
Documented system; remote protected settings
5 - World Class
Automated system maintains setting integrity
6)Are controls in place to assure actions are taken in the event of calibration failure?
1 – Deficient
No system
2 – Marginal
Documented system with no sign-off
3 – Acceptable
Documented system with general sign-off
4 – Preferred
Documented system with QA sign-off
5 - World Class
Automated system forces response flow
7)Is the maintenance by a systematic preventative maintenance system?
1 – Deficient
No system or audits
2 – Marginal
Documented system with periodic audits
3 – Acceptable
Documented system with individual group responsibility
4 – Preferred
Documented system with dedicated group responsibility
5 - World Class
Automated system
10) Are all new tools registered in the calibration/maintenance system before release to production?
1 – Deficient
No system or audits
2 – Marginal
Documented system with periodic audits
3 – Acceptable
Documented system with individual group responsibility
4 – Preferred
Documented system with dedicated group responsibility
5 - World Class
Automated system linking production and calibration systems
11)Are quarantine/deviation procedures in place for out of calibration or maintenance equipment?
1 – Deficient
No system
2 – Marginal
Documented system with no machine level lockout; lot level deviation tracking
3 – Acceptable
Documented system with machine level lockout; lot level deviation tracking
4 – Preferred
Documented system with machine level lockout; unit level deviation tracking
5 - World Class
Automated system with production lockout/deviation
12)Is a time based or cycle based system implemented to track calibration/maintenance?
1 – Deficient
No system
2 – Marginal
na
3 – Acceptable
Documented system tracks time or cycle
4 – Preferred
Documented system tracks time and cycle
5 - World Class
Automated system tracks time and cycle
13)Is each piece of equipment characterized to determine its performance baseline?
1 – Deficient
No equipment characterized
2 – Marginal
Some equipment characterized
3 – Acceptable
Critical equipment characterized
4 – Preferred
All equipment characterized
5 - World Class
All equipment characterized and matched
14)Is Mean Time Between Failures (MTBF)/Mean Time To Repair (MTTR) calculated for each piece of equipment at the system, subsystem and major components levels?
1 – Deficient
No system or monitoring
2 – Marginal
Documented system with periodic monitoring
3 – Acceptable
Documented system with individual group tracking
4 – Preferred
Documented system with dedicated group tracking
5 - World Class
Automated system tracking
15)Are statistical methods used to evaluate maintenance frequencies?
1 – Deficient
No system or monitoring
2 – Marginal
Documented system with periodic audits
3 – Acceptable
Documented system with individual groups monitoring maintainence frequencies
4 – Preferred
Documented system with dedicated group monitoring maintainence frequencies
5 - World Class
Automated system adjusts maintainence frequencies
16)Has repair spare parts usage been analyzed, and are spare parts stocked accordingly?
1 – Deficient
No system or monitoring
2 – Marginal
Documented system with recurring restocking
3 – Acceptable
Documented system with individual groups monitoring spares
4 – Preferred
Documented system with dedicated group monitoring spares
5 - World Class
Automated system monitoring with link to purchasing systems
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