Saturday, February 2, 2008

Review: Quality Assurance (QA)

Quality Assurance (QA)
What does quality assurance ?

1. product need specification : inspection of finish product
2. GMP : being follow
3. inspection of safety
4. consumer complains
5. QA schedule : tests right
6. raw ingredient specification

Basic quality assurance responsibility

1. inspection of supplies and materials
2. inspection (physical, chemical and microbiological evaluation of raw product., raw ingredient
3. schedule in operation
4. measure product problem (efficiency)
5. inspect finished production
6. preparation of specification of produce and written handbook form
7. preparation of statistical procedure and schedule
8. sanitation inspection (equipment)
9. waste disposal control
10. conformance to regulation (legal, state, federal)


Function of quality assurance

1. specification : standard of spec.
2. developed test procedure
3. developing sampling procedure, what when, where, how to take care sample
4. record data & reporting data - give you information eg. report standard of plate count
5. trouble shooting (for develop) - keep people from problem eg. Require new product/consumer's complain
6. special problem
7. training of personal - make sure people know to run the test

Quality assurance department : 4 areas

1. Q. control : means to regulate to some standard. It is usually associated with the production line, specific process and operation. The tool for production worker to help the operation line with the predetermined parameters for any given quality level.

Function
- incoming material
- preparation stage
- measure processing conditions
- processing
- cooling or holding

2. Q. Evaluation : mean to taking a measurement of the product in laboratory, include the evaluation of all incoming materials, products in process, and or finish product.

Function
- Sensory test; Physical evaluation, Chemical evaluation, Microbiological evaluation

3. Q. audit : mean to verify or examine the products or even processes over time.

Function
- test /inspection
- check shelf life
- market review
- consumer complain

4.Q. other (miscellaneous)
- product development
- consumer evaluation
- sanitation /GMP/ inspection
- waste management
- research

Basic fundamentals for a successful QA program

- QA department (organization)
- personnel
- sampling
- standard and specifications
- measurement: lab, equipment, procedure, report
- interpretation

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