Preventing quality problems
Quality Assurance Standards
The ISO 9000 series of QA Standards
When is QA appropriate
How to implement a QA system
Strategies for maximising effectiveness
in its broadest sense, is any action taken to prevent quality problems
from occurring. In practice, this means devising systems for carrying
out tasks which directly affect product quality.
To implement systems for an organisation, you need to carry out three basic steps: first develop the system; second, document it (this takes the form of policies, procedures, and reference information); and third, inform, instruct, and train staff to use it. This process is illustrated below.
Systems of various kinds are, of course, already an integral part of all organisations. But in most cases they do not thoroughly address quality as a separate and important issue. This changes when an organisation embraces and pursues quality assurance. Quality assurance does not only apply to products. Services, and even "non-production" activities such as administration and sales, benefit from a quality assurance approach.
Quality Assurance Standards are published documents which describe in detail what systems should be used by a company to manage quality.
The table below lists some of the QA standards issued by various bodies.
|Name of QA standard||Issuing body||Applies to:|
|ISO 9001: Quality Systems - Model for quality assurance etc.||International Organisation for standardization||General supplier qualification|
|Code of Good Manufacturing Practice (GMP)||Australian Health Authorities||Pharmaceuticals and sterile products|
|Testing Laboratory Certification standard||National Assoc. of Testing Laboratories (NATA)(Aust)||Qualification of testing laboratories|
|API Q1 Quality Program||American Petroleum Institute||Suppliers to the US petroleum industry|
|Mil-Q-9858||US Dept. of Defense||Suppliers to the US Defense Forces|
Standards exist because many large organisations will not buy from suppliers
who cannot give them assurance that they have systems which support quality.
These large organisations include Government Defense Departments, Health
Departments, car manufacturers such as Ford, Toyota, and General Motors,
and Aerospace companies such as Boeing and Lockheed.
Until the mid 1980's these large organisations published their own standards or codes for suppliers to follow, and their staff would audit supplier companies regularly to make sure they followed the code. It was not unusual for a supplier to be audited separately by a number of larger customers, all with their own quality system codes. In some instances suppliers hosted 30 or 40 quality system audits a year from all their major customers. To reduce the number of audits to which individual suppliers were subjected, the International Organisation for Standards (ISO) published a series of standards in 1987 known as ISO 9000. Most large purchasing organisations accepted this worldwide standard and ceased to issue their own codes. They also ceased carrying out their own audits and accepted the findings of independent audit companies engaged by supplier companies to check their systems against the ISO 9000 standards. This allowed supplier companies to reduce the number of audits to two or three per year.
Some of the independent audit companies operating in Australia are Lloyds Quality Assurance Services, Quality Assurance Services (QAS), Bureau Veritas, Benchmark Certification, SGS QA Services, and National Assocation of Testing Authorities (NATA).
ISO 9000 is the name of a series of QA standards recognised by over 200 countries around the world and adopted as their national standards for QA. In Australia this series has been named the AS 3900 series, but this will change in mid 1995 to the AS/NZ/ISO 9000 series to identify it more closely with the international standard. AS 3900 and ISO 9000 have identical contents.
The most important document in the ISO 9000 series is ISO 9001. This is the code against which audits are actually carried out (two other documents, ISO 9002 and ISO 9003, can also be audited against but these are 'cut down' versions of ISO 9001 for companies which do not need to comply with the entire code). All the other documents in the ISO 9000 series provide guidelines and explanations for how to apply ISO 9001.
The principal features of ISO 9001 are that it,
These requirements are illustrated in the diagram below.
In addition, ISO 9001 requires organisations to include documented systems in their QA system to cover all aspects of:
The basic principle of QA - working out the best course of action beforehand and communicating it reliably to all those concerned - should be applied whenever a planned process is complex, has implications for other processes, or has wide or repetitious application. Beyond this, the decision to follow the specifications in a comprehensive published QA standard rests on your organisation's answers to the following questions:
You can implement quality assurance in a general way by identifying the tasks, processes, or systems critical to the business and writing clear guidelines and instructions for staff. Use these guidelines and instructions for training and day-to-day reference. For the tasks, processes and systems covered, this will reduce:
You can then take this general principle of clearly documenting tasks, processes and systems to the next level by using ISO 9000 (or another appropriate QA system code) as a model for covering all aspects of quality, and for establishing formal disciplines for controlling information accuracy, and reviewing and improving systems. The two levels of implementation are summarised in the table below. The table also lists the additional things you can do to make your quality assurance easier to apply and even more effective.
|Strategies for maximising effectiveness|
|Document guidelines and instructions for critical tasks, processes and systems||more consistent results, savings in time and materials, easier improvement|
|Implement a recognised QA standard||coverage of all key quality related activities, better control of systems, external recognition through Certification|
|Improve the readability of information by writing, structuring, and presenting it to professional technical writing standards||information is more easily understood and more readily accessible, greater savings in time and materials|
|Make information available via computer||quicker and easier access, reduced paperwork, easier to keep up-to-date and accurate, significantly easier to change and improve|
|Integrate with computerised work flow systems||quicker and easier access, further reductions in paperwork, direct connection with activity|
|HCi provides training and course packages for Continuous Improvement tools and techniques.|
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