Quality Procedures

Most companies have set in place procedures to meet the requirements of the international quality standard e.g. ISO 9001 or national equivalents, as discussed in Section B, 3.2.23. The requirement of these standards are that procedures are in place for all activities carried out in the workplace, that these procedures are recorded and that the activities are carried out, by staff, as described in the procedures. The operation of these procedures is subject to an external audit, to confirm that there is compliance in the day-to-day activities of a work group. It should be noted that having procedures written down does not necessarily mean that an organisation has the best procedures in place. They will need to be constantly monitored and modified in the light of experience. 

Typically the procedures for which an R D Manager will be directly responsible, include  

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Figure 5.9 illustrates some of the possible error reduction strategies available. Apart from the specific strategies set out in Figure 5.9, the PIF analysis also indicates which PIFs should be modified to reduce the likelihood of error. In the case of the chlorine loading example, the major scope for improvements are the reduction of time stress and distractions and the development of better quality procedures. 

In addition to proper training and quality procedures, good performance requires a supportive culture and working environment. The procedures provide the "how to," the training reinforces this with the backgrovmd, the understanding, and the practice to develop the necessary skills the environment must support their quality execution. 

The various elements of the error management program such as the development of high quality procedures and training and effective feedback and communications systems need to be supported by policies and standards to implement these policies. The development of these policies is an important strategic aspect of the implementation process. 

Finally, the laboratory s freedom to subcontract tests or make use of outside services is strictly defined, to ensure that work placed with an accredited laboratory is not farmed-out to a laboratory with inadequate quality procedures. 

A system for auditing and reviewing quality procedures is a specific requirement of ISO/IEC 17025, ISO 9001 and GLP. This is a critically important aspect of any quality management system so we will consider these activities in some detail. The first, and most important, thing to realize about Quality Audit and Management Review is that they are two completely different activities. This section deals with auditing while Section 9.5 deals with management review. 

Quality Manual and Quality Procedures (QPs) Note which QPs from the Quality Manual are applicable ... 

Test and calibration Quality procedures Software development life cycle Documentation requirements Training O M manuals... 

Validation Policy Plans Training Plans GMP Risk Assessments) Validation Rationale Organisation Chart Validation Procedures Quality Procedures... 

All revised documentation must be checked and approved by designated personnel and placed in the validation file. All superseded documentation must be marked as such and dealt with in accordance with site quality procedures. 

T.A. Ratliff, The Laboratory Quality Assurance System A Manual of Quality Procedures and Forms, Van Nostrand Reinhold, New York, 1993. 

Another important feature for the inventor is to keep detailed records of all experimental work. This requirement should have been built into the R D group s quality procedures as outlined in Section B, 3.4.1. 

Communications have an important part to play in the successful implementation of a project. External communications have already been discussed as part of the formal launch of the project. It is a good idea to have similar communications at important milestones during the project s lifetime. Internal to the project team it is necessary to have progress reports for team members and the human resource responding to them. To be effective the reports must be concise, accurate, and produced at regular intervals, with just sufficient detail for them to be speedily read. Progress reports, as well as notes on meetings, will also be required for inclusion in Project Folders as a part of the quality procedures within the company. 

Further, the operator will evaluate individually each chemical detected by AMDIS to control if the QA parameters for this compound are fulfilled. The acceptance criteria are defined in OPCW quality procedures (see Annex 3). 

If a periodic review identifies the need to reestablish or test the confidence in the validated status, the computer system should be revalidated. Equally, if significant changes have been made or if regulatory requirements have altered, it may be deemed prudent to revalidate a computer system. In practice, the attention of operational staff to quality procedures and records often wanes unless they are carefully coached or monitored (see also Inspection Readiness in Chapter 15). As the period between successive revalidations increases, so too does the likely amount of revalidation work required (see Figure 12.4). Intervals of between 3 to 5 years between revalidations are typically appropriate. 

Level 2 Evaluate the quality procedures used by companies to control their operations. 

Confirms that quality procedures matches practice (audit report)... 

The current professional ventilation standard (ASHRAE 62-89) suggests two approaches to ventilation a ventilation rate procedure and an air quality procedure. The former provides a tabular approach to ventilation requirements office buildings require 20 ft of outside air per occupant per minute to maintain occupant complaint rates of environmental discomfort at below 20%. This assumes relatively weak pollution sources. When stronger sources are present, the same rate will provide less satisfaction. For example, when smoking is permitted at usual rates (according to data from the early 1980s), 30% of occupants will complain of environmental discomfort. The second approach requires the selection of a target concentration in air (e.g., particulates, VOCs, and formaldehyde), information on emission rates (pollutant per time per mass or surface), and... 

Knobeloch D, Ehnert S, Schyschka L, Buchler P, Schoenberg M, Kleeff J, Thasler WE, Nussler NC, Godoy P, Hengstler J, Nussler AK (2012) Human hepatocytes isolation, culture, and quality procedures. Methods Mol Biol 806 99-120... 

Botanical identification involves both macroscopical and microscopical inspection of the raw material. According to WHO, the macroscopical identity of plant materials is based on the shape, size, colour, surface characteristics, texture, fracture and appearance of the cut surface of leaves, herbs, seeds, fruits, barks, stolons, rhizomes and roots. Literature reports of poisonings and deaths resulting from the consumption of Digitalis collected by mistake for Comfrey (Symphytum) and of Oleander instead of Eucalyptus leaf tea highlights the importance of this simple and basic part of the quality procedure. 

The quality control procedure can be viewed as the framework built around the component specification which will translate the development laboratory target (ideal) into the mass production consumables (practical). The quality procedure is devised to achieve consistency of component deliveries by realistically ... 

It is for this exceptional crisis that the quality procedure must include a route for concessions, whereby material normally considered unacceptable can (after full inter-or intra-department agreement, possibly involving machine and distribution trials, product functional tests, etc.) possibly be given a qualified release. The decision to release must not be the sole responsibility of QC, but a group decision in which QC is one member (the one with the initial data on the problem). 

With the exception of a concession , the quality procedure needs to be as precisely defined as the component specification. It will, of necessity, follow a similar format (Table 4.1). 

Care must be taken with a new innovative company which may initially lack in-depth quality systems, and it may be necessary to help introduce quality procedures compatible with the quality demands. This would be far easier than trying to teach innovative design concepts. 

It is for these reasons that all companies should possess a quality manual which contains the formal policy on company quality. This should be produced by the quality department but have chief executive authorisation. Specific quality procedures should be included in a quality plan, which can be presented as either one complete plan containing a sub-chapter for individual components/component ranges, or a separate plan for each and every individual component/component range. 

Quality procedures must detail the type and route of sampling, inspecting and testing, which will include ... 

To be competitive in terms of specification and quality, a modem supplier must have a thorough understanding of its own process capability, its quality ability and its market position. The evaluation must therefore work to the strength of the supplier, by relating that ability to the customer s quality requirements. To that extent, the customer must ensure that its component specifications are complete, that its quality procedures are comprehensive and realistic, and then classify all the details to the supplier s satisfaction. At that point it may be necessary for the customer to use its quality expertise to aid the supplier in improving its quality systems (see above). 

On completion of the successful examination, the supplier must agree the final component quality procedure since this is an integral part of the commercial contract. 

The quality assurance unit is generally independent from the laboratory and answers to the manager of the organization with which the laboratory is affiliated. The QAU is responsible for implementing quality procedures and assessing them on a continuing basis this will include audits of the laboratory from time to time. 

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