Transition Support

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Quality Assurance

The ISO 9000 definition states that quality assurance is part of quality management focused on providing confidence that quality requirements will be fulfilled. Both customers and managers have a need for quality assurance as they cannot oversee operations for themselves. They need to place trust in the organization’s processes and thus avoid constant intervention. 

Customers and managers need:

• Knowledge of what is to be supplied (This may be gained from the sales literature, contract or agreement).
• Knowledge of how the product or service is intended to be supplied (This may be gained from the supplier’s proposal or offer).
• Knowledge that the declared intentions will satisfy customer requirements if met (This may be gained from personal assessment or reliance on independent certifications).
• Knowledge that the declared intentions are actually being followed (This may be gained by personal assessment or reliance on independent audits).
• Knowledge that the products and services meet their requirements (This may be gained by personal assessment or reliance on independent audits).

You can gain an assurance of quality by testing the product/service against prescribed standards to establish its capability to meet them. However, this only gives confidence in the specific product or service purchased and not in its continuity or consistency during subsequent supply. Another way is to assess the organization which supplies the products/services against prescribed standards to establish its capability to produce products of a certain standard. This approach may provide assurance of continuity and consistency of supply

Quality assurance activities do not control quality, they establish the extent to which quality will be, is being or has been controlled. This is born out by the definitions for quality control and quality assurance in ISO 9000 from which we can deduce that quality control concerns the operational means to fulfil quality requirements and quality assurance aims at providing confidence in this fulfilment both within the organization and externally to customers and regulators.

All quality assurance activities are post event activities and off line and serve to build confidence in results, in claims, in predictions etc. If a person tells you they will do a certain job for a certain price in a certain time, can you trust them or will they be late, overspent and under spec?. The only way to find out is to gain confidence in their operations and that is what quality assurance activities are designed to do. Quite often, the means to provide the assurance need to be built into the process such as creating records, documenting plans, specifications, reviews etc. Such documents and activities also serve to control quality as well as assure it. Therefore, ISO 9001 provides a means for obtaining an assurance of quality, if you are the customer, and a means for controlling quality, if you are the supplier.

Quality assurance is often perceived as the means to prevent problems but this is not consistent with the definition in ISO 9000. In one case the misconception arises due to people limiting their perception of quality control to control during the event and not appreciating that you can control an outcome before the event by installing mechanisms to prevent failure such as automation, mistake-proofing, failure mitigation etc. Juran provides a very lucid analysis of control before, during and after the event in Managerial Breakthrough.

In another case, the misconception arises due to the label attached to the ISO 9000 family of standards. They are sometimes known as the Quality Assurance standards when in fact, they are Quality Management System standards and ISO 9001 in particular, is used for assuring customers that suppliers have the capability of meeting their requirements. The requirements within the standards therefore do aim to prevent problems and hence the association with the term Quality Assurance. It is true that by formalising your quality management system, you will gain an assurance of quality, but assurance comes about through knowledge of what will be, is being or has been done, rather than by doing it. Assurance is not an action but a result. It results from obtaining reliable information that testifies the accuracy or validity of some event, product or service. Labelling the prevention activities as Quality Assurance activities may have a negative effect particularly if you have a Quality Assurance Department. It could send out signals that the aim of the Quality Assurance Department is to prevents things from happening! Such a label could unintentionally give the department a law enforcement role.

Quality Assurance Departments are often formed to provide both customer and management with confidence that quality will be, is being and has been achieved. However, another way of looking upon Quality Assurance departments is as Corporate Quality Control. Instead of measuring the quality of processes, products and services they are measuring the quality of the business operations and by doing so are able to assure management and customers of the quality of products and services that the organization provides.

Assurance of quality can be gained by the following steps illustrated diagrammatically in the Figure below

1. Acquire the documents which declare the organization’s plans for achieving quality.
2. Produce a plan which defines how an assurance of quality will be obtained i.e. a quality assurance plan. Organize the resources to implement the plans for quality assurance.
3. Establish whether the organization’s proposed product or service possesses characteristics which will satisfy customer needs.
4. Assess operations, products and services of the organization and determine where and what the quality risks are.
5. Establish whether the organization’s plans make adequate provision for the control, elimination or reduction of the identified risks.
6. Determine the extent to which the organization’s plans are being implemented and risks contained.
7. Establish whether the product or service being supplied has the prescribed characteristics.

In judging the adequacy of provisions you will need to apply the relevant standards, legislation, codes of practices and other agreed measures for the type of operation, application and business. These activities are quality assurance activities and may be subdivided into design assurance, procurement assurance, manufacturing assurance etc. Auditing, planning, analysis, inspection and test are some of techniques which may be used.

More information about techniques used in quality assurance can be found in Chapters 42, 43 & 55 of the ISO 9000 Quality Systems Handbook 7E

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