Responsibilities for quality control

As a general principle it is important that the maximum responsibility for quality be exercised as close as possible to 

Alternative 1 gives a powerful independent quality function which certainly has advantages. However, with this arrangement quality can develop into an independent empire in parallel with construction supervision. The resulting relationship can be conflictual. 

there is only one fundamental lesson to be learnt upon which everything else depends and that is that if a quality management system is to become an integral part of a company s culture, top management must consider it essential and will in consequence provide the necessary resources and ongoing dynamic support. 

Construction contractors are the organizations which physically carry out the work on site. In fact, it is no exaggeration to say that the success of the construction phase of a project is very much bound up with the selection of competent contractors, engaging them under sound contractual conditions and creating an environment on site to enable them to fulfil their role to the satisfaction of all parties. With this in mind it is vital to define from the outset what is expected of a construction contractor concerning quality management. 

Construction contracts can be placed on the basis of covering a single discipline, or by grouping within the one contract two or more closely associated disciplines indicated with asterisks as follows  

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Much valuable research has been devoted to developing the basic principles for the production of frozen fruits and vegetables of high and uniform quality. If this knowledge could be applied to its fullest extent, there would be little need for concern over the quality of such foods. Before this can be done, those responsible for quality control must be provided with suitable standards of quality and condition, and objective methods of analysis which will clearly indicate conformance or nonconformance to the standards. Responsibility for this resides with the research food technologist or chemist. It constitutes a rich field for profitable and practical research. 

Damaged containers should not be issued unless it is certain that the quality of the material inside is unaffected. Where possible, damaged containers should be brought to the attention of the person responsible for quality control. Any action taken should be documented. 

This is the batch-to-batch variation of ampholytes. To subtype Tf ( ) pH 5-7 ampholytes (LKB) are used. Hhile lots 48 and 50 produced the desired patterns demonstrated in the literature, it was impossible to resolve the C1C3 phenotype when lot 49 was used (unpublished data). These problems have been observed for Servalyte and Pharmalyte as well. To avoid these problems in the future ampholyte manufacturers will have to take responsibility for quality control. 

Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for Quality Control should normally be involved in the study of such problems. 

Any departures from defined procedures must be recorded and agreed upon with the Production manager and the person responsible for Quality Control before final release of the product. 

The person responsible for quality control should have at his disposal the services of control laboratories. 

Person responsible for quality control. He must be free to exercise his responsibilities under conditions which guarantee him independence of judgement. 

He assembles all of the constituent parts of the batch manufacturing and packaging record and transmits them to the person responsible for quality control. 

Decision of acceptance or rejection by the person responsible for quality control. 

In order to participate effectively in the system of quality assurance, the person responsible for quality control requires access to the services of appropriate control laboratories. These laboratories verify the conformity of the raw materials, packaging materials and of the various products to the specifications of the dossier of the medicine and carry out tests to ensure the smooth running of the production operations. 

The results of the controls carried out by the control laboratories must be transmitted to the person responsible for quality control so that he can, after examination of the batch records, independently evaluate the quality of the batch and make a decision of acceptance or rejection. 

The laboratories should issue control reports signed by the persons responsible for the laboratories, summarizing the results of analyze and tests. These reports must be sent to the person responsible for quality control, who must attach them to the batch record before taking the decision of acceptance or rejection. 

The personnel assigned to the operations of taking samples must be under the authority of the person responsible for quality control. The operations of withdrawing samples make special demands on the recruitment, selection, knowledge, motivation and training of the staff who must be trained and made aware of the importance of their role. They must be motivated and aware that sampling is a precision technique in the same way as analysis and that steps must thus be taken to do it meticulously. 

Sampling plans must be recorded in writing and approved by the person responsible for quality control. 7.22 It is appropriate to note that the measures indicated above and in the following paragraph are addressed essentially to chemical raw materials. A modification and special,well-chosen conditions need to be observed for products of plant or animal origin received as such and these are laid down by the person responsible for quality control. 

According to the written instructions given by the person responsible for quality control, the person taking the samples must proceed as follows ... 

Persons in responsible positions should have sufficient authority to discharge their responsibilities. In particular, the person responsible for Quality Control should be able, impartially to carry out his defined functions. Save in exceptional circumstances persons engaged part-time or in a consultative capacity should not be appointed to key positions. Persons should be designated to take up the duties of key personnel during their absence. 

Each delivery should be visually checked on receipt for general condition, integrity of containers), spillage and possible deterioration, and be sampled by personnel and tested by methods approved by the person responsible for quality controls. The samples should be tested for compliance with the starting material specification in.certain circumstances, partial or entire compliance with specification may be demonstrated by the possession of a certificate of analysis, combined with first- hand assurance of identity. 

Labels indicating status should only be attached to starting materials by persons approved by the person responsible for quality control. Such labels should be of a nature or form which prevents confusion with any similar labels previously used by the material suppliers (e.g. they should bear the company name or logo). As the status of... 

Finished products returned from the market and which have left the control of the manufacturer should be considered for re-sale, re-labelling, or incorporation with a subsequent batch only after they have been critically assessed by the person responsible for Quality Control. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should ail be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered suitable for re-issue or re-use, although basic chemical re-processing to recover active ingredients may be permissible. 

The organization must appoint an officer responsible for production and an officer responsible for quality control and must preclude any intervention in their activity. These officers are ... 

The Production Manager, in addition to his responsibilities for production areas, equipment, operations and records for the management of production personnel and for the manufacture of products in accordance with the appropriate Master Formulation and Manufacturing instructions, will have other responsibilities bearing on quality which he should share, or exerdse jointly, with foe person responsible for Quality Control. 

The person responsible for Quality Control should have foe authority to establish, verify and implement all quality control procedures. He should have foe authority, independent of Production, to approve materials and products, and to reject, as he sees fit, starting materials, packaging materials and... 

In some companies there is appointed a Quality Assurance Manager who oversees all the quality assurance arrangements and reports to senior management The person responsible for Quality Control may report to the Quality Assurance Manager and share some of the responsibilities with him. 

There should be packaging material specifications, approved by the person responsible for Quality Control. 

Although analysis and testing may be undertaken by a Contract Analyst, the responsibility for Quality Control cannot be delegated to him. 

The authorities and responsibilities of the manufacturing expert and the quality control expert are defined in writing by the responsible director. The responsibility for quality control and manufacturing cannot be placed at the person of one expert. The responsible director and the personnel responsible for quality control and manufacturing cannot resume other job engagements except those endowed by elections at professional societies. 

The key personnel are the person responsible for Production and the person responsible for Quality Control, who should be different persons, neither of whom should be responsible to the other, but who both have a responsibility for achieving the requisite quality. 

NOTE—The duties of the person responsible for Quality Control are wider than those which may be suggested by such terms as Chief Analyst , Laboratory Head etc.]... 

Persons in responsible positions should have sufficient authority to discharge their responsibilities. In particular, the person responsible for Quality Control should be able to carry out his defined functions impartially. 

The person responsible for Quality Control should have the authority to establish, verify and implement all quality control procedures. He should have the authority, independent of Production, to approve materials and products, and to reject as he sees fit starting materials, packaging materials and intermediate, bulk and finished products which do not comply with the relevant specification, or which were not manufactured in accordance with the approved methods and under the prescribed conditions. (His authority in relation to packaging materials may be limited to those which may influence product quality, identity, and safety in use). 

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