The Quality Manager

Quality Manual A document describing the quality management system of an organisation (ISO 9000 2000). 

One of the prerequisites for running a quality organisation is to have the necessary quality systems in place. These will be usually adopted at the company level and it is the job of the R D Manager to implement, monitor and maintain the system within the laboratory environment. 

All companies, whatever their size, need to appoint a Quality Manager, even if in smaller companies this is combined with other duties. Anyone with management experience may be suitable for the appointment, but in R D the Quality Manger showed be suitably qualified, experienced and competent in the core technologies of the company. 

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Define the quality management requirement for assuring the quality of the work. 

It is not my purpose here to elaborate on inventory management as this is a management function in its own right. From the quality management viewpoint, however, there are some factors that need to be considered. 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

The first step is to understand the Quality Management system within your company. Your company s existing programs may be formal or informal or a mixture of both. Characteristics of these are briefly described below. 

You will need to undertake a series of interviews to understand existing PSM and ESH programs. You may also need to conduct some interviews to confirm aspects of your quality management system. However, if the Quality Management system is not well documented this may indicate a weakness, and you should reconsider the wisdom of moving forward with the proposed integration. It is essential to test how the processes are actually functioning, as this frequently differs from any description, formal or informal. 

Understands the quality management system you will be using... 

Use Fishbone diagrams to identify all the process needs. This will draw heavily on the work to identify the PSM and ESH programs and elements and the Quality Management requirements. It will also identify any special expertise, information or equipment needs. Fishboning is described in several of the quality management references given in Chapter 1, and an example is provided in Exhibit 5-4. 

There is a large array of Quality Management tools available to help build new systems. The most commonly used tools are described in the following paragraphs. The tools you actually use may be determined by the Quality Management process that is in place in your organization it is important... 

The overall management structure must be clearly outlined in organisational charts or other appropriate means. To demonstrate the organisation s commitment to quality, it is normal for the Quality Manager to report directly to the Chief Executive Officer. Regular... 

Short description of the quality management system of the firm responsible for manufacture. 

Briefly, the quality management system is a combination of quality management, quality control and quality assurance. Quality assurance and quality control are components of the laboratory s quality management system. There is often confusion over the meaning of quality control and quality assurance and regrettably they are often used interchangeably. This is possibly because some quality control and quality assurance actions are interrelated. The definition of the terms can be found in the International Organization for Standardization (ISO) Standard, ISO 9000 2005 [2],... 

The content, size and format of the Quality Manual will depend on the nature of the organization. As described in Chapter 9, the quality management standards... 

The initial resource requirement will therefore be the effort required to agree the quality management system structure and content and compile the information as a Quality Manual. This process often takes several months to complete and, according to the size of the laboratory concerned, may involve a number of staff allocating a significant proportion of their time to this work. It must be remembered that the quality management system must be tailored to the work - not the work tailored to the quality management system. 

The top management of the organization produces the quality policy. This sets out the overall objectives of the quality management system. It should include reference to the management s commitment to good professional practice, compliance with the quality standard, and a framework for establishing and reviewing quality objectives. 

All members of staff of a laboratory are responsible for ensuring that they are familiar with the quality management system, as set out in the Quality Manual and any supporting documentation. They are expected to follow the... 

The report form should be completed by the auditor and passed to the Quality Manager immediately after the audit. 

This form should be completed by the auditor and copied to the Quality Manager, Division Head, and laboratory representative. At the expiry of the agreed timescale, the auditor should check whether improvement/corrective action has been completed and a report copied to the Quality Manager. 

And further, that the responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement . Similarly, ISO 9001 (2000) states that, Where an organization chooses to outsource any process that affects product conformity, the organisation shall ensure control over such outsourced processes. Control of such outsourced processes shall be identified within the quality management system. ... 

The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual. 

The laboratory shall establish a policy and procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the quality management system or techiucal operations have been identified. The procedure for corrective action shall start with an investigation determining the root cause(s) of the problem. 

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