Name
Bio-Rad iCode Introduction.mp4
Assuring Product Quality and Safety
Our goal is to make a difference in the world with safe, effective, high-quality products for use in research and healthcare.
Our products are innovative, and while we always seek to make improvements, exceed expectations, and try new ideas, we never do so at the risk of quality and safety. We comply with the regulations and standards that govern the design, development, production, labeling, promotion, and distribution of our product
All of us involved in the full product lifecycle are responsible for knowing and following the product quality and safety requirements related to our role. This means that not only do we follow specifications and quality control procedures, but we also ensure that all required inspection and testing operations are complete.
We must follow good manufacturing practices (GMPs) and related regulations and standards to ensure that processes are clearly defined and well-documented, and that employees are formally trained to develop methods to improve product quality and customer satisfaction.
Expectations
- We are committed to following the product quality and safety standards that apply to our role at Bio-Rad.
- We comply with standards related to the development, manufacturing, labeling, sales and marketing, and approval of products.
Key Terms
The testing of product samples against the acceptable standard.
Good practice quality guidelines and regulations govern our work practices (e.g. GMP, or good manufacturing practice, or GCP, good clinical practice). The purpose of good practice guidelines is to ensure that a product, process or practice is safe and meets the intended use.
Standards that govern our manufacturing processes to ensure that products are made to applicable quality expectations.
The sequence of stages that a product progresses through from introduction to maturity. It includes stages such as identifying need, research and development, manufacturing, sales, and product retirement.
FAQs
A: You should raise the issue with your supervisor. You should not proceed with using the machine until the issue has been reviewed with QA and documented, and a decision has been made regarding control of the affected product pending the recalibration.
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A: No. GMPs and other regulations must be adhered to completely. If you have a suggestion for a change, inform your manager, but we cannot simply ignore GMPs that apply to our work.
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