Meet Process Requirements and Comply with Quality Standards
Quality regulations are for your consumers’ protection. Ensuring that your equipment, processes and procedures meet not just the regulations in your area, but global quality regulations is essential to ensure the strength of your brand.
Quality is a warranty of customer safety
The objective of quality regulations is to ensure customer safety. As with Good Manufacturing Practices, ISO22716 sets the framework for good practices that will ensure that customers’ safety is preserved.
Compliance and risk
It is the user’s responsibility to ensure, (1) that measuring instruments are appropriate for their usage and (2) that they are verified and calibrated regularly according to applicable standards. If the regulations set the framework for meaningful requirements, it is the user’s responsibility to decide on the implementation details. One important step to compliance is to complete a risk analysis. Probability and impact of a wrong measurement must be evaluated to quantify the risk, and appropriate measures must be implemented to mitigate these risks. For a weighing system, the risk analysis helps determine the type and frequency of the routine tests that need to be performed regularly on the instrument.
Process requirements are sometimes misunderstood. They consist of the following: Process Tolerance, Measuring Range and Safety Factor. As the conditions of utilization will vary over time (different operators, changes in temperature or pressure, vibration and wear and tear) it is important that an instrument is not used up to the limit of its capability. Therefore, a safety factor is applied on the lowest value of the measuring range (minimum weight) to prevent out-of-tolerance measurements that result in out-of-specification results.
If a scale cannot achieve the required process tolerance, quality is in jeopardy and out-of-specification results will be too high. An auditor will verify that the documentation is complete and the scale is calibrated. He or she also provides the right tolerance in the given measuring range. This is documented by a Minimum Weight Certificate.
Frequent non-compliant scales
Research indicates that more than 20 percent of the scales used for production do not comply with the declared process requirements for which they are used.
The analysis of GWP® Verification, developed by METTLER TOLEDO, could demonstrate that in many cases, the declared and documented measuring range didn’t reflect the demanded process tolerances used in production. After making the appropriate corrections to the documentation and the operating procedures, many of the suspect scales became compliant. Mismatches that would lead to audit issues can only be spotted if the appropriate methodology and tools are used.
METTLER TOLEDO’s analysis also indicated that a frequent source of audit issues is an inappropriate calibration and verification schedule. While many customers spend too much time verifying their instruments, and wasting a lot of productive time, others implement insufficient verification and calibration activities. GWP® Verification provides precise recommendations on calibration and verification requirements.
GWP® Verification is a service offering that verifies the customer’s weighing process and ensures that the scales used meet the demanded process tolerances. While taking the applicable regulatory requirements into account, GWP puts effective calibration and routine testing schemes in place. METTLER TOLEDO identifies the gaps and provides recommendations and bullet proof solutions to close them. With GWP® Verification, it is possible to quickly and inexpensively evaluate the different weighing processes in place and to take the necessary measures to achieve true compliance with the applicable regulations. Request more information or an in-house seminar about GWP® Verification: