Quality Assurance Standards and registration
Whenever anyone mentions Quality Assurance, a picture is created of myriads of white-coated inspectors, running around with sheaves of paper. That they are actually contributing to a company’s efficiency would probably produce a horse laugh. That they are giving a benefit to the customer would create his disbelief.
In November 1979 a report to the UK National Economic Development Council was made by the Heating, Ventilating, Air Conditioning and Refrigeration Equipment Sector Working Party. Whilst this was not for publication, some important comments were made which had a galvanising effect on some of the larger UK fan manufacturers. These implied that there would be growing pressure at home from European manufacturers who, attracted by the abnormal buoyancy in the market at that time, were increasing their share. They would be expected to consolidate this hold when the world moved into recession, and as UK firms could comfortably supply normal home demands, competitive pressures would be fierce. How right they were!
At the same time, conditions in other world markets could not by any means be described as similar. UK manufacturers had been achieving a growing reputation in Europe for reliable deliveries and competitive price, albeit from an earlier period where they could claim neither. However, they were coming up against less obvious, but just as effective, barriers to trade. Many countries had certification schemes and demanded that UK fans be passed through their test houses before they would be allowed into their country. This could take 12 months and lose the order. No prizes are given for guessing who used these sorts of subterfuge in protecting their home industry! More annoyingly, some third world countries specified non-British certification schemes, placing UK products at a considerable disadvantage.
The UK Government had separately been expressing overall concern at the generally perceived low quality of all British goods and was asking how this impression could be corrected. (It later resulted in a National Quality Year and the publication in 1983 of a White Paper — “Standards, Quality and International Competitiveness”.) Industry had in mind that Government would be able to trade off a British scheme with those of the country into which it hoped to export i. e. reciprocal recognition of each other’s registration. This would at best unlock the unseen barriers to trade, or at lease ensure a “tit-for-tat” relationship.
The scene was therefore set, and a demand for registration was voiced on many sides. The first of many meetings took place between the then Department of Trade and Industry (DTI), Department of the Environment (DOE), users and fan manufacturers. Following the accord between the government and BSI, the latter were chosen to develop and administer the resultant scheme. The essential elements of the Certification of Air Movement Equipment (CAME) Scheme were eventually decided and were:
I) A Quality Assessment Schedule ref 3284/37 relating to the design, manufacture and testing of air moving equipment and ancillaries coming within the scope of BS 848 — Fans for General Purposes.
Ii) Registration of the applicant company as a “firm of assessed capability” when measured against the requirements of BS 5750 Part 1 — Quality Systems Specification for design, manufacture and installation.
Iii) All performance data to be published in accordance with BS 848 and the manufacturer to be able to substantiate such data by the necessary tests. BSI inspectors to visit the company periodically to audit its quality procedures.
The scheme offered manufacturers the ability to demonstrate a commitment to quality, thereby building customer confidence and eliminating the need for multiple assessments. Having been formulated by BSI with the assistance of both users and manufacturers it provided, by means of assessment and subsequent surveillance, an independent assurance of a firm’s capability of working to specification. This, before the event, assurance is distinct from redress under contract warranty or the law, which can only operate after the event.
It conformed to the guidelines of the National Quality Campaign launched by the UK Government in 1983 and had received the approval of the Department of Trade and major purchasing organisations. The first four companies to be registered received their certificates at the House of Commons on Wednesday 14 December 1983. By the 11 March 1985, 10 companies had been registered with further additions “in the pipeline”. It was suggested therefore that the Property Services Agency (PSA) commitment to make the scheme mandatory when there was sufficient choice of suppliers had now arrived. As a certain Frenchman said when defending the use of the guillotine, “implementation of this requirement encourages the others".
It must be said, however, that at this stage there was a feeling within the UK industry that whilst it was endeavouring to play a good game of cricket (European companies were quickly registered under CAME), some overseas opposition indulged in rule-less all-in wrestling. The hoped-for reciprocal agreements were not implemented and the delays in achieving other countries’ approvals continued. In consequence the CAME Scheme “died”, leaving a lot of disillusioned fan manufacturers. Only the Quality Assurance element survived and the industry continued its search for a certification scheme (see Section 17.11).
If I went to my local car showroom to buy a Ford and proffered my Ј8000,1 would not expect to receive a Rolls-Royce. Each, however, could be said to be a quality product.
Before we discuss quality assurance, therefore, we must agree on what is meant by quality. Amongst the many definitions which have been proposed, perhaps the best and simplest is “fitness for purpose”. But this really begs the question. What does being fit for a particular purpose actually mean? For how long should it be fit and who is to decide?
Within the building services industry there are many different people who have to be satisfied — consulting engineer, contractor, user company — and right down to its maintenance engineer. Ultimately it is the customer who has to be satisfied. With some temerity it is suggested that his expectations could be unreasonably high (he may only have paid for a “banger” and he may have wanted a quality product). If the customer (whoever he may be) is not to feel disappointed then there must be some agreement right from the initial enquiry as to what those reasonable requirements really are.
They may be obvious from custom and practice in the industry, or they may have to be worked out in detail before any order can be placed. The implications, where technology is rapidly changing, where the time to produce specifications is limited, where new companies (home or overseas) are entering the market place, and where contracts are the subject of intense competition is that:
• there is a need for some independent assessment of quality
• minimum requirements need to be supported by industry standards which must not however inhibit innovation
• like must be compared with like when determining the successful tenderer
• when coming back for “more of the same”, the user must be assured that the product will indeed be repeatable.
With all the above in mind, the following revised definition of quality is therefore suggested:
“The ability to meet a customer’s reasonable needs and expectations, bearing in mind the technical constraints, time constraints and price charged.”
And here our problems begin!
In a company of any size or complexity desirable things don’t just happen of their own accord; they have to be made to happen. Devotees of Northcott Parkinson and Murphy will know, however, that undesirable things will happen with spontaneity, inevitability and rapidity. We must therefore have a quality system which ensures that the customer’s needs are first identified and then implemented.
The 1982 UK Government White Paper on quality standards and international competitiveness explained the needs and laid down the objectives in a form which for succinctness, the author believes, has not been improved upon:
“Quality assurance, in the form of sound technical and administrative procedures for ensuring quality, offers more scope for reducing cost and enhancing competitiveness and profitability than many other management controls. It does this by reducing materials wastage, lost production times, re-work, extra handling and rejections. Improved quality and reliability, by improving customer satisfaction, lead to increased sales competitiveness, reduced warranty claims and premium pricing.”
The elements that a quality system must cover were worked out, codified, and made available in a UK Ministry of Defence Specification 05-21 and out of this grew BS 5750 (which was to be expected as the Chairman of the committee was an Admiral!). Out of this in turn grew ISO 9001, (= EN 29001). There are now other similar Standards in other parts of the world but in general, if a company meets the requirements of the latest edition of ISO 9001, the others can usually be met without difficulty.
All quality systems require procedures to be documented, work to be done against written instructions, the results of inspections and tests to be recorded, and so on. In a sentence — everything must be written down. The system must be regularly reviewed to ensure it remains effective and can successfully pass any audits carried out either in house or by the customer/assessment authority. Instances of error or poor quality should be identified and corrected. Where this does not happen, or where there are delays in correction, then senior management must be advised.
It should be especially noted that Quality Assurance is not the same as Quality Control. Whilst Control comprises inspection and other activities designed to ensure that defective goods do not leave the factory gate, Assurance is aimed at minimising the chance of error before it actually happens. It may well use inspection and other similar techniques to provide a feedback on how the company is performing, but it is much more far-reaching.
The introduction suggested that there would not be lots of paperwork. Why then all this writing down? It must be emphasised that once a quality system is in being, there is then less need for individual written instructions relating to a particular contract. They will all exist and should cover the totality of the firm’s work. The initial effort in producing a Quality Manual will be amply repaid many times over.
Other advantages may be summarised as follows:
• written procedures capture know-how or experience, and the company becomes less vulnerable to the absence or loss of staff
• the training of new staff is made easier
• written instructions reduce the possibility of misunderstandings
• documentation provides the objective evidence against which assurance can be given that the company is working well.
The paperwork is there simply to ensure that the right materials and information arrive at the right time at the place where the work is to be done. It also ensures that those doing the work know what is required of them, and that once the work is done, the results are passed on to the right place in the correct form.
In any organisation the scope of each director or manager has to be defined to ensure harmonious working. So it is with the Quality Assurance Manager, referred to in most Standards as the “management representative”. He and his department are responsible for the implementation, development and maintenance of the documented procedures. Ideally the Quality Manager should report directly to the Managing Director, or failing this, have direct access to him in case of dispute. Only in this way can the quality versus quantity conflict be resolved and the company retain its quality reputation.
By carrying out these tasks, the quality staff will gain expertise. It may therefore be convenient, although not essential, for them to be responsible for other activities inspection, standards or the issue of quality related documents. Even if there is no specialist department, such documents would still have to be produced. It is totally illogical to assume that they are part of some mysterious additional activity invented by the Quality Manager.
The basic responsibilities of the Quality Manager may therefore be summarised as follows:
• to develop and maintain the quality system
• to negotiate with the customer’s quality representatives
• to negotiate with the quality representatives of his own firm’s suppliers
• to ensure that quality problems with the company are resolved
• to carryout audits of internal and suppliers’ quality systems.
Generally speaking, the Quality Assurance Manager does not solve the quality problems, but rather seeks to ensure that the system highlights any difficulties. Those that stem from faulty design have to be tackled by the engineering department, whilst those which result from faulty manufacture are the responsibility of the production department.
If one wishes to measure the quality performance of a company, there are perhaps three important questions to be asked:
I) is there a system for reporting the costs involved in rework, scrap, trouble-shooting, customer complaints and warranty claims?
Ii) is there a complete system for detecting quality problems, finding the real causes, providing solutions and reporting delays in their resolution?
Iii) does the quality system cover all activities in the company, including design, contracts, purchasing, manufacture, installation and service?
Unless affirmative answers can be given to all these questions, senior management is unlikely to know the size of the quality problem, or to have ensured that the quality assurance effort is sufficient. However good the system may appear, it is unlikely to be effective. It must be remembered that all parts of a company must operate efficiently to achieve a quality product.
The major step for any company wishing to be assessed to ISO 9001 is to produce a quality manual. This document provides the basis for the subsequent independent audit. Other essential elements of the manual are detailed below, with some brief comments. When assessing the company, the inspector will ascertain whether instructions are being followed and whether any non-compliance seriously affects the company’s ability to manufacture products which adhere to specification. Remedial action, and a timescale for completion, may be recommended. In serious cases Certification may be withheld.
1) Organisation: The company structure should be identified and the responsibilities of each director or manager defined. A key post and focal point within the system organisation is that of Quality Assurance Manager, referred to as the “Management Representative”.
2) Review of quality system: The Quality Assurance Manager is responsible for reviewing the Quality System, normally by means of an audit. This should be carried out at regular intervals to suit the size of company and type of work.
3) Planning: The progress of a contract through design, development, manufacture, packing and despatch, requires careful co-ordination. The Quality system must have a plan for assessment prior to work commencing. This planning must allow for everyday items, such as installation, operating and maintenance instructions, as well as the “special” where, for example, the material specification might change, or special testing may be required.
4) Work instructions: Clear and completely documented instructions, referring to a method of work or a procedure, are required to ensure a consistent standard and quality of the product. When training is required, the Work Instructions maintain this consistency and can be supplemented with “on the job” training.
5 Records: For a quality system to work records must be maintained. This provides documented evidence for the customer and demonstrates the performance of the quality system.
6) Corrective action: All faults should be reported to the Quality Assurance Manager, who can instigate the necessary actions to correct the fault. Such corrective actions should require a feedback so that he can monitor their effectiveness. Where different interests conflict, he should seek a suitable solution with the persons involved. If a dispute should arise with the Quality Assurance Manager, then he must have access to the Chief Executive of the company for a final decision.
7) Design control: The company has to show that it has control of this function, however performed. A manual setting out all procedures and methods of calculation usually satisfies the requirement. Whenever changes are made, it is essential that all drawings are updated, the issue status changed, and some means of identifying at which particular unit, the change was incorporated. Drawing records are essential, and these should detail the reason for any amendments.
8) Documentation and change: All paperwork relating to quality must be maintained up to date. This requires that records be kept of all holders of documents, that there is an acceptable method of updating and that all those out of date are destroyed.
All equipment used shall be numbered and its details recorded in a central register. The dates when last calibrated and the interval between calibrations shall be known and adhered to. Any in-house calibration shall be by an experienced person and traceable to an independent, approved, external test house.
10) Control of purchased material and services: The systems employed by the company should ensure that all outside materials conform to specification and are uniquely identified.
11) Manufacturing control: All operations must be carried out under controlled conditions and the criteria for workmanship shall be prescribed to the greatest practicable extent. Inspection shall be carried out after each operation that affects quality.
12) Purchaser supplied material: Free issue material should be subject to the same sort of control to ensure that the correct quantities are received and that it is suitable for use.
13) Completed Item inspection and test: These are necessary to confirm that the goods fully comply with the specified requirements.
14) Sampling procedures: These should be to a statistically proven method or as agreed with the customer.
15) Control of non-conforming material: All such items should be segregated and recorded so that the success rate of the system can be measured and updated as necessary.
16) Indication of inspection status: Means shall exist for identifying whether material is acceptable or not at each stage of manufacture.
17) Protection and preservation of product quality: Procedures shall exist for clean and secure storage, stock rotation where appropriate and adequate packing and transport.
18) Training: A company policy is required to ensure that functions are carried out by persons with suitable training.
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