Introduction to Product Quality Systems Chapter 4

Introduction to Product Quality Systems Chapter 4

Overview • Statistics play a role in Quality assurance • Quality system is the organizational structure, responsibilities, procedures, processes, and resources that ensure quality of a product or service • How do you get ketchup out of the bottle – Bang the bottom – Work from the top

Quality Systems in Different Workplaces • Academic Research Laboratories • “Doing Good Science” – Using consistent, thoughtful, and effective methods – Keeping honest and thorough records – Verifying results – Employment of “good laboratory practices”

In Companies that are regulated • Quality of products may mean life or death • Quality system used is current Good Manufacturing Practices (c. GMP) – Evolved due to relationship between producers of drugs and government – Are followed by companies that package, distribute, market, sell, and use medical products/drugs.

Regulations • GMPs are quality principles formulated into regulations • Regulations are requirements that government imposes on an industry and companies within the industry • Compliance is required by law • Regulations are objective and focus on safety, efficacy, and honesty

Companies that voluntarily comply • Products that are not food, medical, or used by humans are unregulated • Some quality standards may apply • Standard is any concept, method, or way of doing things that is established by some authority, by custom or by agreement • ISO, International Organization of Standards (ISO), is a series of quality standards

ISO 9000 • Established 1987 • Address quality management and promote international trade and cooperation • Is a series of standards with 5 documents – – – ISO 9001 covers production ISO 9002 covers QA in production and installation ISO 9003 QA in final inspection and testing ISO 9000 guidelines for 9001, 9002, 9003 ISO 9004 helps implement 9001, 9002, 9003

ISO 9000 Vs GMP • Voluntary • Monitored by auditors • Generic standards for any group • Requires a company written quality manual • Originated in Europe • Required by law • Enforced by FDA • Standards specific to pharma/drug industry • Quality manual not required • Originated in US

Quality systems and the individual • Based on type of job • Good book keeping and procedures are critical • FDA may verify records of lab technician • Notebook is critical as a book keeping tool – Helps to justify findings to colleagues – Helps in repeating tests and processes

Quality Documents • Language – May be vague, not specific – Published as guidelines and points to consider • Common Elements – Documentation • If it isn’t written down, it wasn’t done • Do what you say and say what you do

Continued • Resources – Skilled personnel with appropriate supervision – Facilities, equipment and instruments – Raw materials – Maintenance of equipment, instruments, and materials

Change Management • In: –R&D – Manufacturing environment – Raw materials – Equipment – Computer methods • Managing or dealing with change is critical for the success of the company