Good Weighing Practice

Transcription

1 Good Weighing Practice GWP Good Weighing Practice Guaranteed Quality Minimized Risk Reduced Costs Secure Audits Minimize Weighing Risk by Adopting Good Weighing Practice

2 Weighing Competence Regulatory compliance & increased productivity & the principles of Good Weighing Practice Whatever the industry, regulatory compliance is an essential part of modern manufacturing. Regulations cover almost every aspect of the manufacturing process and a failure to meet these regulations can be expensive both financially and in reputation. The weighing experts of METTLER TOLEDO help you understand which factors affect the reading and the performance of a weighing device and the quality of your products. how the selection of the right scale is critical for meeting your manufacturing requirements and assuring the quality of your products. the regulations that govern weighing so that your weighing processes are in full compliance all the time. The GWP process Good Weighing Practice is a guideline that allows you to improve your whole measuring process. It is based on a defined set of activities and culminates in the production of documentation that can be used to justify the steps taken to an external or internal auditor. Routine operation Evaluation An optimal level of activity leads you to compliance. Not more, not less! Don t compromise between: Managing your risks Managing your quality Managing your productivity Calibration Installation Selection We can help you find the right balance. The five step GWP process Example: GMP 21 CFR part 211 Subpart D-Equipment GWP : at the heart of regulatory compliance Automatic, mechanical, and electronic equipment. Automatic, mechanical or electronic equipment [ ] shall be routinely calibrated, inspected or checked according to a written program designed to assure proper performance. Written records of those inspections shall be maintained. How do we (I) put this into practice? 2 METTLER TOLEDO Hazardous Area

3 Evaluation Understanding your process Using metrology and operating procedures to mitigate risks STEP 1: Evaluation Evaluating your needs means understanding the regulations governing your industry but also asking the right questions about your process. Manufacturing and regulatory compliance: Each manufacturing process operates to different parameters to ensure optimal product quality: Process tolerances Weighing range and Minimum Weight Operational risks Applicable standards (GMP, ISO, IFS, BRC, HACCP, etc.) Courtesy Takasago Metrology and operating procedures impact your quality. In the past, the interpretation of the regulations and the selection of a weighing device have not always been considered together. Experience proves that it is not only the weighing instrument, but also its environment and the way it is used that impacts directly on quality. GWP addresses the needs of all current Quality Management Systems such as ISO, IFS, BRC, GMP and HACCP, it relates them to your weighing process and puts them into meaningful practice for your specific application. GWP helps you ask the right questions to meet all quality relevant standards. METTLER TOLEDO Good Weighing Practice 3

4 Selection STEP 2: Selection Fact based selection of the weighing system Ensures compliance and productivity It is often the smallest component in a recipe that has the greatest impact on the final product. This is why the Measurement Uncertainty and the Minimum Weight play a critical role in correct scale selection. User Question: So how do I select the correct scale to meet my manufacturing tolerance of ±1%? Answer: Select the scale with the appropriate Minimum Weight. Minimum Weight The Minimum Weight is the weight at which the relative measurement uncertainty becomes higher than the tolerance required by the process (e.g. ±1%). Any measurement above this limit would not comply with the required manufacturing tolerance. The MinWeigh function Once determined during calibration, the Minimum Weight of the scale is stored on the terminal. Then an icon will appear on the display if the operator tries to weigh below the Minimum Weight. GWP and scale selection During the Evaluation Step you determine the smallest net weight of your process. During the Selection Step only the scales that meet both your manufacturing requirements and have an appropriate Minimum Weight will be recommended. Load on Scale (g) Absolute measurement uncertainty (g) Relative measurement uncertainty (%) 1 ± ± ± ± ± ± Data taken from an actual 60kg scale with a readability of 1g For more information on Minimum Weight, download our dedicated brochure and learn all you need to know about the parameters that really influence your weighing process and their impact on quality. 4 METTLER TOLEDO Good Weighing Practice

5 Installation STEP 3: Installation Professional installation Ensures scale performance. Right from the start! GWP recommendation report Once the Evaluation and Selection Steps have been completed the Mettler toledo weighing experts will generate a unique report describing the weighing system that best meets your specified requirements (see opposite). In addition to the appropriate weighing instrument, the GWP recommendation describes also the most suitable installation type and scale verification procedures based on the regulations applicable to your process. IPac An IPac provides the framework for installation and configuration of the weighing system. Furthermore it is the base for the first calibration and the training required by the operators. Comply in no time with GMP qualification requirements (IQ, OQ,) or with the requirements of ISO, IFS or BRC. For more information on IPac s log onto METTLER TOLEDO Good Weighing Practice 5

6 Calibration STEP 4: Calibration Proven performance Bullet-proof traceability Calibration All current quality management systems (GMP, ISO, IFS, etc.) request the user to document the performance of their instruments and to make them traceable to national/international standards. Calibration verifies the effective performance of the instrument within its actual operating environment Minimum Weight Certificate Add a Minimum Weight Certificate to your usual Calibration Certificate and make your quality documentation bullet proof. That way you are in compliance with your process requirements all the time (see opposite). with all external influences present. The resulting calibration certificate documents this procedure by stating the Measurement Uncertainty of the weighing system (see page 4). Calibration, IPac and the Minimum Weight Certificate The recipe to successful audits! Find more about calibration and the Minimum Weight Certificate. Go to: 6 METTLER TOLEDO Good Weighing Practice

7 ) Values within the warning limit: No action is necessary. Values between the warning and control limit are within the tolerance but must be kept under surveillance. Corrective action may be appropriate, depending on the direction in which the values are changing. 2) Values within the control limit, see 1) Values beyond the control limit show that weighing process is no longer under control and immediate action is therefore required. Routine operation STEP 5: Routine operation Monitoring performance Routing testing to assure compliance Routine operation The day to day operation of your scale will impact its performance. This is why you will need to recalibrate it at regular intervals (e.g. once per year). Specially trained The GWP recommendation (see an example opposite) provides clear guidance as to: The type of test required The weights to be used The class of weight to be used The frequency of the testing The warning and control limits for the routine testing technicians will verify and adjust your scale to its optimal performance. But what happens between the calibrations? Will your scale deliver tomorrow the performance required to ensure quality? GWP gives you a clear recommendation about simple verification tests you can perform at regular intervals. The routine testing procedure will depend on the risks and the tolerance of your process. example The GWP recommendation includes clear advice on testing procedures individually based on your risk and process tolerance. Detailed Standard Operating Procedures (SOPs) are also available for each of the recommended routine tests. Routine Testing of Scales SOP for periodic eccentricity tests (routine tests) Title: SOP for periodic eccentricity tests Document No.: Author: METTLER TOLEDO Industrial Number of pages: 4 Controls Replacement document: N/A Reason for revision: N/A Release date: June 20, 2008 Release for routine operation Reviewed by: Date: Signature: Approved by: Date: Signature: Routine Testing of Scales General Basic rules for using scales Before using a scale, make sure the scale power was switched on for a sufficient period of time (mentioned in the scale operating instructions). Make sure the scale is leveled. Minimize environmental influences, e.g. open windows, vibrations, temperature changes or strong drafts. Place objects gently on the scale platform. Basic rules for handling weights Test weights Only commercial test weights with up to date calibration certificates can be used for certifying the "traceability" of scale equipment. Test weights should always be placed gently on a clean scale platform and returned immediately in their storage place after use. Test weights (since they are also part of measuring equipment) need to be re-calibrated at specified intervals (ISO 9001). Any incident, which might have affected the value of the test weight, should trigger an immediate re-calibration. METTLER TOLEDO calibration services can offer a recommendation. Test weights should pe protected from shocks, scratches, dirt and any other external influence that might degrade their integrity. How to store test weights Test weights should be stored in their original box. Test weights should be stored in a clean and dry room. How to move weights Small test weights should only be handled with appropriate tools such as forks or handles (see METTLER TOLEDO s accessories for weights). Always use care when handling test weights, to avoid possible contamination or damage. Eccentricity test Preparation Before the test is performed, the test weight must be acclimatized to the ambient temperature of the scale. Prepare a sheet to note the readings of the eccentricity test. Test procedure Place the test weight in the center (1) of the scale platform and tare (if required) Place the test weight on position 2 at Left front Note: Move the weights by lifting them; do not slide weights over the scale platform Read the stable value from the display and note it Repeat the measurements on positions 3, 4 and 5. Evaluation The largest reading (positive or negative) at any of the 4 corners (2 to 5) is the eccentric load deviation. Evaluate whether the eccentric load deviation exceeds the defined Warning limit 1). Evaluate whether the eccentric load deviation exceeds the defined Control limit 2). Deviation Warning limit 1) (where defined) If the warning limit is exceeded, level the scale and repeat the test. If the warning limit is exceeded again, report that the warning limit was not met to the appropriate supervisor or the person responsible of the scale. Optionally, contact METTLER TOLEDO service organization for advice. Control limit 2) If the control limit is exceeded, report the problem to the appropriate supervisor or the person responsible of the scale. Mark the scale as out of control limits. Contact METTLER TOLEDO service organization for advice. SOP for eccentricity tests Page 2 SOP for eccentricity tests Page 3 METTLER TOLEDO Good Weighing Practice 7

8 Good Decisions For Safe Weighing For more information Mettler-Toledo AG CH-8606 Greifensee Tel Fax Subject to technical changes 04/2009 Mettler-Toledo AG Printed in Switzerland MTSI xxxxxxxx With Good Weighing Practice METTLER TOLEDO has developed a global guideline for the selection, operation and testing of weighing systems. GWP is a risk-based management system that puts all the current regulations like GMP, ISO, IFS, BRC, HACCP into a straightforward weighing practice. Follow a simple program to assure compliance at any time. Evaluate risks, ensure measurement security and save costs. With GWP you receive a tailored and easy to implement recommendation that will enable you to achieve the best weighing results at reasonable costs.