Testing contains many activities other than execution. When we consider the testing life cycle the following are the phases:
1. Test Planning and control
2. Test analysis and design
3. Implementation and execution.
4. Reporting and closure activities
QA-Quality assurance: contains the activities that are performed to measure the quality for example:test execution,reporting etc.
QC: Quality control: It consists of necessary measures that are taken to maintain the quality when deviated.
Quality Assurance: Activities and Responsibilities:
1. Release of qualification and validation protocols
2. Release of documents: e.g. specifications; Master Batch Records, SOPs
3. Batch review and release, archiving
4. Release of batch records
5. Change control, deviation control, investigations
6. Approval of validation protocols
8. Internal audits, compliance
9. Supplier qualification and supplier audits
10. Claims, recalls, etc.
Quality Control: Activities and Responsibilities:
1. Development and approval of specifications
2. Sampling, analytical check and release of raw materials, intermediates and cleaning samples
3. Sampling, analytical check and approval of APIs and finished products
4. Release of APIs and final products
5. Qualification and maintenance of equipment
6. Method transfer and validation
7. Approval of documents: e.g. analytical procedures, SOPs
8. Stability tests
9. Stress test
You have delivered a good difference of activities and responsibilities of QA and QC
department and persons..
For in depth conceptual difference between QA and QC members may refer to Ritu's reply on discussion on QA and QC.
I am equally thankful to both Kamalnath and Ritu.
Keep to your onwards journey.
_________ JAY ________
_______ JAY _______
1. A planned and systematic set of activities necessary to provide adequate confidence that
requirements are properly established and products or services conform to specified
2. An activity that establishes and evaluates the processes to produce the products.
3. Helps establish processes.
4. Sets up measurements programs to evaluate processes.
5. Identifies weaknesses in processes and improves them.
6. QA is the responsibility of the entire team.
7. Prevents the introduction of issues or defects
8. QA evaluates whether or not quality control is working for the primary purpose of determining
whether or not there is a weakness in the process.
9. QA improves the process that is applied to multiple products that will ever be produced by a
10. QA personnel should not perform quality control unless doing it to validate quality control is
1. The process by which product quality is compared with applicable standards; and the action
taken when nonconformance is detected.
2. An activity which verifies if the product meets pre-defined standards.
3. Implements the process.
4. Verifies if specific attribute(s) are in a specific product or service
5. Identifies defects for the primary purpose of correcting defects.
6. QC is the responsibility of the tester.
7. Detects, reports and corrects defects
8. QC evaluates if the application is working for the primary purpose of determining if there is a flaw
/ defect in the functionalities.
9. QC improves the development of a specific product or service.
10. QC personnel may perform quality assurance tasks if and when required.