3. Quality is the totality of features and characteristics of product or services that bear on its ability to satisfy the stated needs.  In simple words “ one can say that a product has GOOD Quality when it complies with the requirements specified by the client.”

4.  Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of the product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the QUALITY required for their intended use.

5.  Quality Assurance is a process based approach. Quality monitoring and its assurance ensures that the process and systems are developed and adhered in such a way that the deliverables are of GOOD quality. This process is meant to produce defect free goods or services which means being right the first time with no or minimum rework.  Quality Control is product based approach. It verifies the product manufactured, satisfies the quality requirements as per the specifications.

6.  Quality Assurance is that assurance of quality which is designed before start manufacturing the product whereas Quality control begins once the product has been manufactured.  Based on the requirement of cGMP, the process & systems are established and documented.  Based on different parameters, standard specifications are developed during the validation of processes.  Quality Control personnel verifies the product manufactured meets all those requirements as stated in the specification or not.  So Assurance of quality is a proactive or preventive process to avoid defects where as Quality Control is a corrective process to identify the defects in order to correct them.

7.  Quality Control Department is actively involved in sampling, analyzing & decision making for releasing or rejecting the every sample, by assessing the quality of the representative sample carefully and accurately by using calibrated instruments & validated method of analysis. i.e. Quality Control is an operational technique.  Quality Control is primarily aimed at the prevention of errors.

8.  In every organisation Quality Assurance Dept. is the most important part, which assures that every product rolling out of the factory is of right “QUALITY”.  Remember Quality cannot be judged into the final product but it need to be judged at the every step of the process by means of validation.  The most of activities of Quality Assurance include documentation of process validation, establishing standards, developing checklists, conducting internal as well as external audits, failure mode effect analysis and TRAINING.

9.  To achieve the confidence level of assuring the Quality of Product, Quality Assurance department conducts TRAINING programme, which are need based.  Thorough training to all the employees is the most important aspect.  It is the TRAINING that gives the thorough knowledge of do’s and don’ts w.r.t. to work on the shop floor. This gives in-depth knowledge & confidence to complete the given task.

10.  TRAINING is given to all the employees in different areas w.r.t.  1) behaviour at work place.  2) about Attitude towards handling of each activity on the shop floor.  3) hygiene and sanitation of the areas  4) precautions to be taken while carrying out activities viz. Validation, Calibration etc.

11.  QA conducts vendor audit before procurement of materials which includes:  verification of premises, facilities, cleanliness at the site, maintenance of records & other important areas.  Q.A. is involved in verification & ensuring that all instruments/ equipments used in different areas are Calibrated / validated/qualified and are in working condition and ensures that machine operators are thoroughly trained to operate the respective machinery.

12.  With the help of QC department, QA conducts the validation of the different methods used in analysis of different products.  QA is involved in preparing the protocols for validation of the manufacturing processes.  QC is actively involved in sampling and carrying out the analysis of all the samples accurately and delivering the results in time.  QA is involved in compilation of data and giving the decision or recommendations wherever required.

13.  QA is involved in regular audits of different areas viz Quality Control, production, packaging, stores department including warehouse.  Besides regular training, QA also involved in retraining of all employees for updating their knowledge and motivation at work.  QUALITY is the collective responsibility of every individual working in the organisation by following the laid down instructions.

14.  Excellence in products, processes and systems can be achieved through TEAM efforts of trained personnel of the organisation.  IPQA is the rowing eye of QA department & controls the different activities online and ensures that responsibilities / accountabilities are followed every time.

15.  Both, Quality Assurance & Quality Control are largely interdependent:  The Quality Assurance department relies on the feedback provided by the Quality Control department.  For example,  If there is a problems in quality of the product, then the Quality control department provides feedback to Q.A. Dept. Then QA dept. investigate the root cause of the problem & brings necessary change to the process or system to ensure that there are no quality issues in future. Similarly, QC department follows the guidelines & standards established by QA Department to verify the products meets predetermined specifications.

16.  Thus both QA & QC departments are the most important constituent of the organisation and are responsible for delivering the Good Quality products consistently.  Quality “Remember Quality is never an Accident but it is the outcome of intelligent efforts”.

17.  Globally Hard work has less importance, but intelligent work has greater importance & that makes the difference.  Remember every individual born on this globe are unique, but only few individuals are the excellent performers and exhibits their difference because these individual knows to explore his /her ideas in intelligent manner.

18. To conclude : To achieve SUCCESS in our life we need to : 1) Have defined Goals and Targets, 2) Have right Attitude, Skill and Knowledge, 3) Have right focus & consistency in our work.

19. Mr. Satyavan A. Pai Vaidya