This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.
The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and testing within the statistical framework.
Presented examples will include an emphasis on the manufacturing processes and quality assurance needs of personnel in the medical device and pharmaceutical industries.
Process and quality control are constantly evolving. Therefore, historical concepts, current trends and regulatory requirements will be discussed. The presentation of statistical charts and analyses, graphical techniques for planning, trouble-shooting and problem solving will also be presented.
Instructions and Complementary Handouts:
- Minitab statistical software will be used to demonstrate data collection and input, and how to build and interpret various process control charts for both attributes and variables data.
- The seminar will also include the use of Minitab to develop attributes and variables sampling plans for quality assurance and acceptance.
- A handout and dataset will be provided to attendees, so they may work hands-on with the information presented in the seminar.
- Understanding of the need and reasons for statistical process control
- Knowledge of regulations and requirements of sound process control and acceptance sampling plans
- Understanding and application of statistical concepts in the development and use of process control and sampling plans
- Step-by-step instructions on how to design and interpret control charts and sampling plans using Minitab software
- FDA QSR, ISO 13485:2016, ISO 9001:2015 regulations and harmonization
- Overview of statistical theory and nomenclature for processes and quality control
- Variability and risk assessment in practice
- Control before testing!
- Which chart for which process?
- Presentation of control charts for discrete and continuous data
- Setting statistical specifications, control limits, and signals
- Attribute and Variables sampling plans
- C = 0/Zero acceptance sampling plans
Who will Benefit:
- Quality assurance (QA) engineers
- Quality control (QC) engineers
- R&D engineers
- Process control personnel
- Manufacturing/Industrial personnel
- Manufacturing/Industrial personnel
- Production supervisors
- Management personnel of processing facilities
In pharma and medical device companies, all processes exhibit intrinsic variation. However, sometimes the variation is excessive and this hinders the ability to achieve reliable measurements and desired results. Statistical process control (SPC) and statistical quality control (SQC) allow us to control the functions of our processes (input) and the quality of our product (output) by providing tangible tools for monitoring and testing.
Process and quality control is important for a company’s reputation. A good system of processing and quality checks reduce costs associated with production waste and re-work due to defects, and allows a company to deliver products that are high in quality. Many industries are also required to have a good quality management system in place to achieve compliance with regulatory authorities.