[81] QA, QC

Quality assurance

Quality assurance covers all activities from design, development, production, installation, servicing and documentation. This introduced the rules: "fit for purpose" and "do it right the first time". It includes the regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production, and inspection processes.
One of the most widely used paradigms for QA management is the PDCA (Plan-Do-Check-Act) approach.

Total quality control

Total Quality Control is the most necessary inspection control of all in cases where, despite statistical quality control techniques or quality improvements implemented, sales decrease.

The major problem which leads to a decrease in sales was that the specifications did not include the most important factor, “What the customer required”.

The major characteristics, ignored during the search to improve manufacture and overall business performance were:

Reliability
Maintainability
Safety
As the most important factor had been ignored, a few refinements had to be introduced:

Marketing had to carry out their work properly and define the customer’s specifications.
Specifications had to be defined to conform to these requirements.
Conformance to specifications i.e. drawings, standards and other relevant documents, were introduced during manufacturing, planning and control.
Management had to confirm all operators are equal to the work imposed on them and holidays, celebrations and disputes did not affect any of the quality levels.
Inspections and tests were carried out, and all components and materials, bought in or otherwise, conformed to the specifications, and the measuring equipment was accurate, this is the responsibility of the QA/QC department.
Any complaints received from the customers were satisfactorily dealt with in a timely manner.
Feedback from the user/customer is used to review designs.
Consistent data recording and assessment and documentation integrity.
Product and/or process change management and notification.
If the original specification does not reflect the correct quality requirements, quality cannot be inspected or manufactured into the product.

For instance, all parameters for a pressure vessel should include not only the material and dimensions but operating, environmental, safety, reliability and maintainability requirements.

To conclude, the above forms the basis from which the philosophy of Quality Assurance has evolved, and the achievement of quality or the “fitness-for-purpose” is “Quality Awareness” throughout the company.