quality assurance

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QUALITY ASSURANCE

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QUALITY ASSURANCE. Objectives. To ensure that the units produce product that meets specified requirement through understanding the product in the customers perspective and effective control of raw materials, all stages of process and product. Vision. - PowerPoint PPT Presentation

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Page 1: QUALITY ASSURANCE

QUALITY ASSURANCE

Page 2: QUALITY ASSURANCE

Objectives

To ensure that the units produce product that meets specified requirement through understanding the product in the customers perspective and effective control of raw materials, all stages of process and product.

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Vision

To have best in class systems and processes in place and continuously improve it through effective knowledge sharing process resulting in products consistently meeting customer requirements.

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The responsibility of Quality Assurance starts from receipt of material till usage of product by consumer, which involves

Control of Incoming material – raw material and packing material.

Control of Process Control of Product – at factory and trade. There is only one way to make products that

meet specification and performance consistently is by having checks and balances at different stages in the way it was designed.

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Control of RM / PM

All raw materials and packing materials have a specification and its performance as an ingredient in the final product.

The raw materials received are tested as applicable. Some of the materials are checked at the vendor’s location

itself. Critical material supply vendors are audited to ensure that

they will be able to supply materials of good quality consistently.

After the material is cleared for its suitability for use, it is stored till its actual use.

The storage condition will depend on the type of material. It will be stored under special condition (controlled condition), if required.

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Control of Process Before beginning of manufacture, all equipments are checked to ensure it is cleaned and fit for the intended purpose. Every product has a recipe and a process. It is ensured that the right quantities of raw materials are added and all process parameters are followed as it was designed.

For this purpose there are in process checks that happen at regular intervals during a process. The process parameters may include quantity of raw materials, temperature, pressure, time, humidity, product performance, etc as specified in the process manual. If at any point of time a deviation is identified, appropriate corrective measures are implemented.

All equipments used for testing and measuring are calibrated on a regular basis as specified in the manual.

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Control of ProductOnce the final product is ready it is tested against specifications – quantity and quality. Products meeting specification are cleared for dispatch and stored in Finished Goods storage area. Products that do not meet the standards are rejected or subjected to rework, if applicable. All the raw material testing, process parameter checks and finished product check data are documented. Though the product is checked during the manufacturing process, while in the factory warehouse, finished goods are randomly selected and tested as per statistical sampling plan. This is to ensure that all products produced are meeting its intended purpose and specifications.

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Technology Transfer

When any new product is made, QA becomes the facilitator to transfer product know-how to the manufacturing unit and then to ensure regular process control on an ongoing basis.

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System Audit Many of our units are ISO/HACCP certified - recertified in Nov 2007 and to be renewed every 3 years thereafter.

Once in a month the manufacturing facility is audited as per the GMP (Good manufacturing Practices) guideline and any deviation identified will be rectified with appropriate action plans.

Each TPU will have QA representatives from CKPL to ensure that the product is manufactured as per our requirement.

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Cont… The CKPL QA representative will ensure that all processes – starting with clearance of raw materials, control of process parameters and clearance of finished product – are adhered to as per the product design. Any complaints that are received on a product would be traced back to the process and corrections will be taken accordingly. Auditing of CFA points / RS points are done on a regular basis to understand condition of product and packaging at different points in time.

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Quality of product cannot be achieved by QA department alone.

It is possible only when all functions – R&D / Operations / Packaging / Purchase / Logistics work as a team. Interaction with all functions happen at varying frequencies depending upon the requirement.

Interaction with other functions

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