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Functions That Support Quality Manufacturing
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QC, QA, Documentation, Training, & Validation
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terms list
Functions That Support Quality Manufacturing
QC, QA, Documentation, Training, & Validation
3 Types of Validation
Process, Equipment, & System
SOP
document that contains specifics on a procedure
ISO
promotes consistent standards for quality among countries around the world, making international trade easier
TQM
an approach to quality based on a total commitment to customer satisfaction ... is reflected in every aspect of the business
ISO 9000
a series of international standards that guide the development of effective quality management systems
ISO Certification
Certification tells customers they can count on the company to manufacture a consistent product
Quality Improvement Systems
an approach used to satisfy the expectations of the customer; Voluntary & Mandatory systems
Voluntary Quality Systems
ISO 9000, TQM, & Continuous Improvement
Mandatory Systems
cGMP, and 21 CFR
cGMP
a set of minimum standards for manufacturing set by FDA to insure safety & purity of drug products made in the USA.
21 CFR
outlines all cGMP for drug, medical device, and biological industries; includes rules for every aspect of manufacturing
BPR
document that provides a traceable record of each batch of product
FDA
government agency that sets the standards for the manufacture of food & drugs
price of poor quality
damage to company reputation; lost customers; lawsuits; high production costs; company shutdowns & lost jobs
Rules of Quality
understand customer needs; say what you do (write procedures); do what you say (follow procedures); prove it (keep records); improve it
quality production goal
is to do it right the first time
Quality Control (QC)
sampling & checking the product & raw materials that go into the product
Quality Assurance (QA)
setting up & checking the systems that assure the quality of the product; examines the process that builds quality into the product, instead of relying only on testing the product itself; more broad than QC
documentation
having written specifications & procedures that say what must be done to manufacture a product
Validation
proves that the manufacturing processes, equipment, & systems will consistently produce a product to described specifications
quality on the job basic activities
monitoring; communicating; following procedures; keeping records; sampling & testing; solving problems & suggesting improvements
monitoring the process
understanding; continually observe; notice trends & changes; use all of your senses; respond appropriately; communicate status; keep records
effective communication
knowing what, when, how, & with whom to communicate; connects all work activity & keeps the operation orderly & efficient
SOP (Standard Operating Procedures)
a document that contains only a procedure; one of the most important documents process techs use
SOP include
Effective date, purpose, scope, responsibility, references, materials & equipment, procedures, & approval signatures
batch sheet
says what must be done & proves that it was done
BPR (Batch Production Record)
includes all documents & records needed to prove hove the batch was made (from start to finish); is critical; if it is not complete or correct, it is worthless; provides proof that product was made to standard
Guidelines for keeping records
federal laws enforced by FDA; must be complete, clear, consistent & accurate; use correct format; record data immediately; do not discuss or make unauthorized copies of any company documents
military time
0000hrs=midnight 2300hrs=11:00 PM
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