Regulations and standards leave a lot open to interpretation regarding performance verification of measuring equipment. Below, we’ve outlined the key aspects of a weighing performance verification plan that includes traceability, process documentation, and testing frequency and procedures.
#1: Performance Verification Regulatory Requirements
There are comprehensive regulations that include performance verification of measuring equipment for pharmaceuticals manufacturers. GMP regulations and ISO specifications agree on the requirements for calibration and the consistent testing of measuring equipment. There are four key elements to consider:
- Equipment should be calibrated and checked at routine, specific intervals.
- There should be a written procedure for calibration.
- Calibrations should be performed with traceable, certified standards.
- Calibration records should be maintained.
#2: A Risk-Based Approach
Regulations and standards are beginning to include risk-based thinking more and more in their approach on quality management. For example, the new version of ISO9001:2015 weaves the concept of risk into the entire management system. Additionally, the FDA, EMA, and ICH have published instructions for a risk-based approach to quality management.
This type of approach ensures that risk is considered throughout the process, which makes preventative action a constant factor in strategic and operational planning.
The intervals for routine testing and calibration are determined based on the assessed weighing tolerance and risk.
- Calibration – The weighing device is tested in order to confirm a relationship between a standard and a measured value. If the measured value is not within the defined tolerance, the weighing device can be adjusted.
- Routine Test – To verify performance of weighing equipment more frequently, routine tests are used in conjunction with regular calibrations.
#3: Setting Up a Plan
In order to plan the performance verification of your weighing device, there are three things you should consider:
- Testing Frequency – Assess the risk of the weighing process in order to determine the risk of each of your weighing devices. Then, define the calibration schedule to ensure accurate measurements over time (anywhere from 1-12 times per year). Next, define the routine testing schedule in order to verify measurement performance between calibrations.
- Testing Methods – There are multiple methods of testing to consider, including sensitivity / error of indication, repeatability, and eccentricity or corner load. For all of them, warning and control limits must be defined according to the weighing risk assessment.
- Test Weights – Be sure to select the right weights according to OIML or NIST standards. Then, choose the right accuracy class, keeping in mind that the tolerance of the weights should be much less than the desired weighing tolerance to ensure correct results. Always use calibrated test weights, and handle them appropriately, including proper cleaning and storage. You may want to consider integrated test weights, which can conveniently test and adjust the weighing device’s sensitivity.
#4: Set Up a Performance Verification Plan
A qualified person must perform periodic calibration and adjustment of weighing devices. Typically, this is an accredited service company that specializes in the calibration of scales and balances.
It’s important to train people who will be conducting routine tests on your weighing device, develop standard operating procedures, and implement those procedures with an integrated test manager.
Additionally, be sure your performance verification is documented with consistent measurements and detailed, audit-proof documentation. It may be wise to consider automatic documentation as part of your weighing device.
Acme Scales Can Help with Performance Verification!
Acme Scales boasts a service department of 11 factory-trained technicians who can calibrate, maintain, and repair most types of scales. Contact us for more information on our “Calibration Service Quality Assurance Program,” and find out how we can assist you!