Key Topics

Principle 3

Staff making analytical measurements should be both qualified and competent to undertake the task.

Why Is It Important?

• Analysts with adequate understanding of the principles underlying a method are more likely to achieve reliable results. Within any method there will be aspects which could be interpreted slightly differently by different analysts. This could mean that the method is being applied outside the scope of validation. There may be a temptation to cut corners to save time without understanding the consequences. Analysts with the right knowledge and understanding will appreciate the risks involved and act appropriately.
• The benefits of using a well chosen method for the task in hand can be entirely undone by analysts who do not have the necessary competences. Analysis is a practical activity and competence in practical work is essential. It is a mistake to assume that the use of well documented methods or automated equipment reduces the need for practical competence.
• Staff who are qualified and competent through good training will feel confident and be committed to quality in their work. In an environment which encourages learning and competence, staff are more likely to be self motivated and accept personal responsibility for the delivery of reliable results

What To Do

• Ensure that appropriate training programmes are devised and implemented for all analysts. Staff should not be allowed to produce results without close supervision until they have been trained and have demonstrated that they can produce reliable results on previously characterised samples. Good training will address both competence and underpinning knowledge. Training requirements should be reviewed regularly and the outcomes of training recorded.
• Use training courses which include an assessment of the knowledge and skills gained on the course. Some courses offer certificates of attendance which give no measure of what has been accomplished. Assessment should be graded according to: competent to work unsupervised, competent to work supervised, or in need of re-training. Levels of competence should be assessed against agreed criteria, preferably national standards of competence recognised by the National Council for Vocational Qualifications.
• Ensure that personal achievement in training programmes is noted and recorded. The recognition by managers of achievement is a strong motivator for staff. Staff who are motivated by their own achievements in training and in professional development are likely to perform better and to seek continual improvement. Training records should be reviewed regularly and within a system of annual performance appraisal. Training records also give customers confidence.
• Make sure that for every sample dealt with in your laboratory, there is a designated 'responsible analyst' answerable for the reliability of the results. This responsible analyst should have been involved in the process of agreeing the analytical specification with the customer (see VAM principle 1). The responsible analyst should fully understand the entire analytical procedure to be applied to the samples.

Additional Information

When dealing with samples unexpected results can happen. The analyst needs to be able to spot these and ideally work out what might be happening. Slavish adherence to written procedures, without being alert to what is actually happening with a sample/analysis, will always run the risk of producing unreliable results. Staff therefore need to have an understanding of the science which underlies the analysis.

Motivation plays a large part in determining the quality of output. Motivation is best achieved by employing a variety of management approaches, such as:

• Make sure staff understand their work and the desired outcomes
• Provide regular feedback and recognition of achievements
• Provide training and support continuing professional development
• Involve staff in decisions relevant to their work
• Try to make the work as interesting and varied as possible

Through this kind of approach, all staff can be encouraged to think carefully about their contribution to the work of the laboratory, and to particular projects. With this comes greater commitment to quality, and an acceptance of responsibility for delivering quality.

Formal qualifications need to be supported and enhanced by continuing education and training. Analytical chemistry is a practical career, and competence in practical work is essential. The best place to acquire competence is the workplace, and staff must be given on-the-job training which equips them to carry out their professional duties. The value of senior experienced staff as role models and mentors cannot be over-estimated. The work of staff should be closely supervised until they have demonstrated that they can produce reliable results on, for example, check samples or other well characterised materials which closely resemble real samples.

Examples

Importance of knowledge and understanding of underlying science.

If a margarine has a label containing information on the fat content of the product then the requirements of the EC Nutrition Labelling Directive (90/496/EEC) have to be met. This directive states that the amount of saturated, mono-unsaturated and poly-unsaturated fatty acid present has to be expressed as g of 'fatty acids per 100 g of sample.' To obtain this information analysts are required not only to separate fatty adds according to chain length and degree of unsaturation but also to separate cis- and trans- geometric isomers. This was shown to cause problems for participants in a proficiency testing scheme. Staff of the laboratory need an in-depth knowledge of lipid analysis as well as gas chromatography (GC) in order to perform satisfactorily. The selection of a GC column with the appropriate polarity is critical if the required separation of geometric isomers is to be achieved.

Training improves reliability and efficiency.

The need for training was highlighted in an article on 'Cost Control in the Laboratory' published in The Referee (The Referee, AOAC International, March 1996 Volume 20, Number 3, page 9-11). It reports that an analyst with 3 years' tenure was found always to have a higher variation between duplicate assays, prepared from the same homogenisation of waxy-matrix-based tablets, than two other analysts had from their independent preparations from the same tablet subsample. When this problem was investigated, it was found that the first analyst had never received any formal training in sample preparation. In fact, when all the laboratory's 50+ analysts were observed homogenising such tablets using a glass mortar and pestle, fewer than 50% knew the proper technique. After all the staff received one hour's corrective and/or reinforcement training, the average variability for all duplicate assays in the laboratory decreased to about 0.7% from a value of 1.3% before the training. The overall investigations of unexpected assay results dropped from about 3 per week to about 2 per month. This represents about 2.5 analyst days per month becoming available as a result of the short training period.

Supporting resources

• Practical Laboratory Skills Training Guides
• Practical Laboratory Skills CD-ROM
• Laboratory Skills Training Handbook
• Assessing competence in key laboratory skills.