Quality Control

Control Objectives for Quality Control

(a) To ensure that the required quality standards are defined, monitored and
complied with;
(b) To ensure that the production methods required to achieve the prevailing
quality standards are adequately defined and communicated;
(c) To ensure that both materials received and goods produced are to the
required standard;
(d) To avoid the additional costs, wasted resources, and erosion of the
organisation's reputation associated with the production of poor quality goods;
(e) To ensure that any relevant statutory and industry quality regulations are
satisfactorily addressed;
(f) To ensure that effective testing and inspection methods are defined and
implemented;
(g) To ensure that production output is appropriately inspected and tested to
ensure the maintenance of quality standards;
(h) To ensure that any quality problems are promptly identified, reported,
evaluated, and resolved: and
(i) To ensure that management are kept informed of defect rates and the
implications of quality problems.

Risk and Control Issues for Quality Control

1 Key Issues

1.1 Have quality specifications been established for materials,

components and finished items, and what form do they take?
1.2 How can management be assured that the defined quality standards
are being cost effectively achieved?
1.3 What measures are in place to identify quality problems or
shortcomings and how can management be certain that all such problems
are promptly and effectively resolved?
1.4 What measures prevent sub-standard and poor quality items from
reaching end customers?
1.5 What mechanisms are in place to ensure compliance with any
prevailing statutory or industry-level quality standards?
1.6 How can management be sure that the established quality assurance,
inspection and testing arrangements are justified and effective?

2 Detailed Issues

2.1 Are quality considerations built into the product design and development
processes in order to ensure that they can be adequately addressed in subsequent
production runs?
2.2 Are measures in place to confirm the quality specification of materials
received from outside suppliers at the time of delivery?
2.3 Is prompt action taken to reject sub-standard supplies and arrange
replacement stocks?
2.4 What measures are in place to effectively assess potential suppliers for
their competence and commitment to quality?
2.5 Have quality specifications been defined, authorised and formally
documented, and how can management be sure that the current and valid
specifications are in use?
2.6 Where achievement of the defined quality standards is dependent upon the
correct application of a specific production process or method, have such
methods been adequately recorded, tested and communicated to all affected
parties?
2.7 What mechanisms are in place in order to achieve an up-to-date
awareness of all relevant regulatory quality standards?
2.8 What measures prevent the production, circulation and marketing of sub-
standard items?
2.9 Are the required testing and inspection programmes defined (i.e. in
respect of sample sizes, the nature of tests, tolerance limits, etc.)?
2.10 How can management be certain that the defined testing and inspection
programmes are being correctly applied?
2.11 Where appropriate, are the organisation's testing processes operated to all
the required regulatory standards (and how is this evidenced)?
2.12 How can management be certain that the testing and inspection staff are
adequately skilled and experienced to perform their duties?
2.13 Where necessary, are the organisation's quality testing facilities certified by
the relevant regulatory/industry bodies?
2.14 Are management kept regularly informed of detected defect rates and the
action taken to correct shortcomings, etc.?
2.15 How is the accuracy of data input from other systems (i.e. product
development) confirmed?
2.16 How is the accuracy of data output to other systems (i.e. Industry
Regulation & Compliance) confirmed?