Quality by Design (QbD) is a concept first outlined by quality expert Joseph M. Juran. Its underlying philosophy is that quality should be built into each process step - not only tested at the end – to ensure consistent final product quality. While initially widely adopted in the automotive and electronics manufacturing, QbD has recently received strong attention in process industries, especially the chemical and pharmaceutical segments. As discussed in this white paper, there are key steps every operation can take to ensure quality is built in to the weighing process.
Weighing is a critical step in many chemical production processes and significantly contributes to final product quality. Building quality into a weighing process helps to ensure accurate measurements over time and prevent operating mistakes that can lead to out-of-specification materials.
Our White Paper details 5 steps to ensuring Quality by Design, including:
- How to ensure weighing process accuracy
- How to prevent operator error
- How to maintain measurement quality
- How to monitor and control the weighing process
- How to ensure you select the right equipment
What is Quality by Design?
Keep Quality in Mind
The Quality by Design concept is a universal, comprehensive approach that consists of three processes:
- Quality Planning Developing products and processes required to meet customer needs
- Quality Control Evaluating actual performance and correcting deviations from quality goals
- Quality Improvement Raising quality performance to unprecedented levels
Learn the details of each step by downloading the white paper!
Quality by Design (QbD) is a concept that quality should be built into each process step - not only tested at the end – to ensure consistent final product quality. While initially widely adopted in the automotive and electronics manufacturing, QbD has recently received strong attention in process industries, especially the chemical and pharmaceutical segments.
Quality and accuracy in weighing can be assured by using solutions that consider the main factors that contribute to consistent weighing practices that are outline in the Quality-by-Design white paper.
Measurement uncertainty can be assessed by testing eccentricity, error of indication, and repeatability.
Weighing tolerances for your process can be defined by following the guidelines set forth by GWP (Good Weighing PracticeTM).
When deciding what scale to use for your weighing process, measurement uncertainty, possible environmental influences and the weighing tolerances must be considered. By using the Scale Selector Guide, a suitable scale for your process will be chosen.
Typical operator errors in formulation are mixing up raw materials, typing or writing mistakes, overfilling, using an unsuitable scale, not collecting all necessary meta data, or forgetting routine
You should calibrate your scale based on the recommendations from an accredited service provider that has been on site to define the specific measurement uncertainty of the given scale. ISO Quality System 9001 specifies “Where necessary to ensure valid results, measuring equipment ... shall be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.… Records of the results of calibration and verification shall be maintained.”
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