ANNEX
Letter from the Lead Officer, Legal Metrology, Institute
of Trading Standards Administration to the Clerk
of the Committee
Quality Systems
The existing arrangements for the verification of weighing and
measuring equipment within the UK rely upon the application of
detailed technical requirements by an inspectorate totally independent
of any commercial interests. Both the technical requirements,
and the operation of the inspectorate, are the subjects of statutory
controls. The success of the current arrangements (whose history
can be traced back over many centuries) is reflected in the fact
that today there is an unquestioned expectation on the part of
the general public that such equipment is always "correct".
The proposal seeks to supplement (and would eventually largely
replace) the existing system, with one based upon the application
of "quality assurance" techniques. Whilst the technical
regulations governing the design and performance of the equipment
itself will remain the same, the arrangements governing the actual
testing of the instruments (currently set out in Section 11 of
the Weights and Measures Act 1985) will be replaced with a system
based upon the principles of "quality assurance".
The accepted national and international standards for quality
assurance are currently set out in the BS EN ISO 9000 Series of
Standards. Like all such standards, these are likely to be revised
or re-issued from time to time, and it is for this reason that
we accept the Department's view that it would be inappropriate
to refer to specific documents in the legislation. (To do so might
necessitate amending the statutory requirements as and when the
Standards themselves were amended).
Conversely, we think it would be equally inappropriate to replace
what have for some hundreds of years been statutory provisions,
with a system which could permit significant changes in practice
to be promulgated through "administrative guidance"
which was not itself subject to Parliamentary scrutiny.
Our concerns relate therefore to the balance between the detail
that is presently contained in Part II of the proposed Schedule
3A (and so cannot be changed without Parliamentary approval),
and those matters currently covered in the supplementary "Guidance
Notes" (Annex E).
We note that under the proposals there are no statutory
obligations for the quality system to provide for, inter alia:-
(a) management review of the quality system (eg Clause 4.1.3
of BS EN ISO 9002);
(b) procedures for maintaining and documenting the system
(Clause 4.2.2);
(c) contract review (Clause 4.3);
(d) evaluation of subcontractors (Clause 4.6.2);
(e) verification of purchased products (Clause 4.6.4);
(f) process control (Clause 4.9);
(g) corrective and preventive action (Clause 4.14); and
(h) internal quality audits (Clause 4.17).
The "Guidance Notes" currently contain "requirements"
that:-
(i) self-verification is limited to manufacturers, installers
and repairers (but not importers) (Para 19);
(ii) the quality system is at least equivalent to accepted
international standards (Para 21);
(iii) a suitably qualified Inspector of Weights and Measures
be included in the audit team undertaking certification of the
quality system (Para 24(a)).
Whilst accepting unreservedly that it is the current administration's
intention to apply these criteria, we must point out that there
can be no guarantee that these "requirements" might
not be changed at some future point in time, and without reference
to Parliament. We consider that requirements such as those listed
are critical to the proper operation of a system of self-verification
and for that reason should be statutory requirements in their
own right.
We would particularly note that certification bodies have not
traditionally undertaken enforcement functions. It is possible
that some bodies (or their auditors) will experience a conflict
between their enforcement obligations under the proposed Order
and their traditional relationship with their clients which has
always been one based upon strict confidentiality. For that reason
we consider that the involvement of a suitably qualified enforcement
officer to monitor the legal metrology and enforcement related
elements of the system will be absolutely critical to its successful
operation.
So far as applicants outside Great Britain are concerned, whilst
we accept that the standards themselves will be the same, we have
concerns as to whether the application (enforcement) of the overall
system can be. A manufacturer in the UK can be subject to random
inspection of his production (the proposed Article 2(13) and could
commit offences (the proposed Article 2(12)). There can, of course,
be no similar jurisdiction in the case of manufacturers situated
outside of the UK.
The periodic auditing of the quality system itself will normally
be undertaken by a certification organisation, operating on a
commercial basis. Such auditing should provide for increased audit
frequencies, where non-conformances are noted, but whilst this
may be undertaken relatively easily within the UK, there will
clearly be a financial disincentive to such increased audit frequencies
in the case of foreign sites. Whilst it is accepted that minimum
routine audit frequencies could be laid down in licence conditions,
it is difficult to see how the system can guarantee equivalent
treatment for both domestic and foreign manufacturers.
Implications for Local Government
It is clear that the proposals will have negative financial implications
for local weights and measures authorities. The scale of the verification
function in the majority of authorities is such that it is unlikely
that it will be possible to achieve economies of manpower or equipment
that will balance the loss of income. In only a few authorities
are manpower and equipment totally dedicated to verification functions.
For example, equipment that currently "earns" an element
of income will still have to be maintained for the residual verification,
and the continuing inspection functions. It is similarly likely
that in the majority of authorities (and particularly the smaller
ones), only a proportion of an officer's time will be spent on
fee-earning verification work. When income is lost, the authority
has the choice of either increasing the cost of the service (through
the community charge, or through increasing the residual fee income),
effecting savings elsewhere, or reducing its establishment (manpower).
In the latter cases, the proposals may well impact upon other
aspects of the Trading Standards service - an authority might
balance loss of income by reducing product testing for Food Standards
or Safety purposes, or make an officer redundant thus impacting
upon inspection functions.
Finally, it should be noted that in the absence of any arrangements
to "ring fence" any additional funding allocation, there
can be no guarantee that the funding will be allocated to the
responsible Department within the local authority.
17 June 1998
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