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 Have the sources of variation identified in the system design been addressed? Design review; verify and validate.
 Calibration and control system: Recommended calibration schedule and audit of equipment and documentation. Frequency, internal or external, parameters, in-process verification checks.
 Input requirements: Mechanical, electrical, hydraulic, pneumatic, surge suppressors, dryers, filters, setup and operation issues, isolation, discrimination and sensitivity.
 Output requirements: Analog or digital, documentation and records, file, storage, retrieval, backup.
 Cost: Budget factors for development, purchase, installation, operation and training.
 Preventive maintenance: Type, schedule, cost, personnel, training, documentation.
 Serviceability: Internal and external, location, support level, response time, availability of service parts, standard parts list.
 Ergonomics: Ability to load and operate the machine without injuries over time. Measurement device discussions need to focus on issues of how the measurement system is interdependent with the operator.
 Safety considerations: Personnel, operation, environmental, lock-out.
 Storage and location: Establish the requirements around the storage and location of the measurement equipment. Enclosures, environment, security, availability (proximity) issues.
 Measurement cycle time: How long will it take to measure one part or characteristic? Measurement cycle integrated to process and product control.
 Will there be any disruption to process flow, lot integrity, to capture, measure and return the part?

 Material handling: Are special racks, holding fixtures, transport equipment or other material handling equipment needed to deal with parts to be measured or the measurement system itself?
 Environmental issues: Are there any special environmental requirements, conditions, limitations, either affecting this measurement process or neighboring processes? Is special exhausting required? Is temperature or humidity control necessary? Humidity, vibration, noise, EMI, cleanliness.
 Are there any special reliability requirements or considerations? Will the equipment hold up over time?
Does this need to be verified ahead of production use?
 Spare parts: Common list, adequate supply and ordering system in place, availability, lead-times understood and accounted for. Is adequate and secure storage available? (bearings, hoses, belts, switches, solenoids, valves, etc.)
 User instructions: Clamping sequence, cleaning procedures, data interpretation, graphics, visual aids, comprehensive. Available, appropriately displayed.
 Documentation: Engineering drawings, diagnostic trees, user manuals, language, etc.
 Calibration: Comparison to acceptable standards. Availability and cost of acceptable standards.
Recommended frequency, training requirements. Down-time required?
 Storage: Are there any special requirements or considerations regarding the storage of the measurement device? Enclosures, environment, security from damage/theft, etc.
 Error/Mistake proofing: Can known measurement procedure mistakes be corrected easily (too easily?) by the user? Data entry, misuse of equipment, error proofing, mistake proofing.

source of Measurement System Build Issues : Analysis of measurement systems

Post Author: ghaemi mohammad

This site has been established to provide updated and specialized information in the field of quality management systems and to share my experiences in the field of conformity assessment and promotion and promotion of this science.

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