Study Set Content:
detects if there is a non compliance from these procedures and takes steps to inform the upper management to take corrective measures.
Audit functions
is a measure of excellence or a state of
being free from defects, deficiencies and
significant variations.
Quality
is describe as any systematic process or
procedure of determining whether a
product or service meets specified
requirements
maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production
Quality assurance (QA)
Quality Assurance descriptions
Defining quality, Improving quality, Measuring quality
is a procedure or set of procedures this is designed to ensure that a manufactured product or performed service complies with a defined set of quality standards or meets the requirements of the end user or customer
Quality Control (QC)
quality control guarantees that
a. Are safe and free of impurities and contaminations. b. Produces a physically and chemically stable product. c. Contains the exact amount of the active ingredients and even inert materials as stated in the label which conforms to the standards. d. Ensures that the active ingredient will be optimally released upon administration producing a good bioavailability.
Minimizes and eliminates the risk of marketing and selling of unsafe products • Guarantees conformance to the standards and regulatory requirements • Ensures product efficiency. • Reduces production cost • Reduces inspection cost • Reduces operating losses • Guarantees a most effective utilization of resources• increases goodwill • Satisfaction of customers are guaranteed
The following are the benefits derived from Quality Control system:
Encourages quality consciousness• Produces higher employer-employee morale• Improves employer-employee relations• Facilitates price fixation • Produces effective advertisements• Improves techniques and methods of production• Motivates the pharmaceutical/medical professions to sell, endorsed, or prescribed the products being sold.
The following are the benefits derived from Quality Control system:
describes a management approach to long-term success through customer satisfaction
Total Quality Management (TQM)
Elements of TQM
– Customer-focused –Total employee involvement –Process-centered – Integrated system
process which deliberates on providing assurance that quality request will be achieved
Quality Assurance
a process which deliberates on fulfilling the quality request
Quality Control
identify and improve the defects
Quality Control
method to verify quality
QUALITY CONTROL
prevent the defect
QUALITY ASSURANCE
technique of managing quality
Quality Assurance
does not involve executing the program
QUALITY ASSURANCE
always involves executing the program
Quality Control
All team members
Quality Assurance
Verification
Quality Assurance
