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, also known as the Shewhart cycle.

[edit] Failure testing

A valuable process to perform on a whole consumer product is failure testing, the operation of a product until it fails, often under stresses such as increasing vibration, temperature and humidity. This exposes many unanticipated weaknesses in a product, and the data is used to drive engineering and manufacturing process improvements. Often quite simple changes can dramatically improve product service, such as changing to mould-resistant paint or adding lock-washer placement to the training for new assembly personnel.

[edit] Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma levels of quality, in other words, so that the likelihood of an unexpected failure is confined to six standard deviations on the normal distribution. This probability is less than four one-millionths. Items controlled often include clerical tasks such as order-entry as well as conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by randomly sampling and testing a fraction of the output. Variances of critical tolerances are continuously tracked, and manufacturing processes are corrected before bad parts can be produced.

[edit] Company quality

During the 1980s, the concept of “company quality” with the focus on management and people came to the fore. It was realised that, if all departments approached quality with an open mind, success was possible if the management led the quality improvement process.

The company-wide quality approach places an emphasis on three aspects :-

   1. Elements such as controls, job management, adequate processes, performance and integrity criteria and identification of records
   2. Competence such as knowledge, skills, experience, qualifications
   3. Soft elements, such as personnel integrity, confidence, organisational culture, motivation, team spirit and quality relationships.

The quality of the outputs is at risk if any of these three aspects are deficient in any way.

The approach to quality management given here is therefore not limited to the manufacturing theatre only but can be applied to any business activity:

    * Design work
    * Administrative services
    * Consulting
    * Banking
    * Insurance
    * Computer software
    * Retailing
    * Transportation

It comprises a quality improvement process, which is generic in the sense it can be applied to any of these activities and it establishes a behaviour pattern, which supports the achievement of quality.

This in turn is supported by quality management practices which can include a number of business systems and which are usually specific to the activities of the business unit concerned.

In manufacturing and construction activities, these business practices can be equated to the models for quality assurance defined by the International Standards contained in the ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor inspection which did not control the major quality problems. This led to quality assurance or total quality control, which has come into being recently.

[edit] 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:

   1. Marketing had to carry out their work properly and define the customer’s specifications.
   2. Specifications had to be defined to conform to these requirements.
   3. Conformance to specifications i.e. drawings, standards and other relevant documents, were introduced during manufacturing, planning and control.
   4. 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.
   5. 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.
   6. Any complaints received from the customers were satisfactorily dealt with in a timely manner.
   7. Feedback from the user/customer is used to review designs.
   8. Consistent data recording and assessment and documentation integrity.
   9. 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.