Quality Management includes all the activities that organisations use to direct, control and coordinate quality. These activities include formulating a Quality Policy, setting quality objectives and establishing quality processes. They also include quality planning, Quality Control, Quality Assurance and quality improvement.
Who Controls Quality in a company?
Previously the overall responsibility for an organisation’s Quality Management System was the sole responsibility of the Quality Manager, who was (i.e. in ISO 9001:2008) often referred to as the ‘Management Representative’. In the new ISO 9001:2015, the title Quality Manager has been dropped and ownership of the QMS does not centre on a single individual; in future, these duties may be assigned to any role or be split across several roles. There have been numerous thoughts and discussions about ISO’s new ‘ruling’ within professional bodies and on social media, and the general feeling appears to be that as this is not conceived to be a mandatory requirement, an organization may, if they so wish, continue to use the term Quality Manager, but with the proviso that Top Management will now have to play a far more important role in overseeing management within their organisation than before – and: Everyone within an Organisation Has a Part to Play in Quality! So what responsibilities do each of these groups of people have?
Management Responsibilities in ISO 9001 :
The main requirements of an organisation’s management are that they:
Fully endorse and are committed to the development and implementation of their organisation’s quality system.
Develop and establish a Quality Policy that can be supported by measurable quality objectives.
Plan, develop, implement, improve and modify their Quality Management System.
Define and communicate organisational responsibilities and authorities.
Ensure that everyone within the organisation plays a role in being part of the effective implementation of the Quality Management System.
Establish (and use) internal communication processes.
Review the Quality Management System at planned intervals.
Having established their overall position, the management will then have to:
Ensure that the organisation’s QMS always meets the requirements of the national, European or international standard to which the particular organisation has chosen to work and, where this fails to happen, to see that corrective actions are carried out;
Define objectives such as fitness for use;
Ensure that the performance, safety and reliability of their products and services are correct and that costs associated with these objectives are kept to a reasonable level.
The Quality Management Team :
It is quite normal (especially for large organisations) that a completely separate and independent division, headed up by someone from Top Management (usually the Quality Manager) who deals solely with quality matters. The organisation of this section ‘could’ look something like that shown in following figure :
For organisations that cannot justify the cost of employing full-time inspectors, other options are available, such as:
Selecting personnel from existing Staff who are not directly involved with a production process. They are then able to act as independent unbiased assessors;
Employing third party quality consultants, on a temporary basis, to carry out fully independent Quality Controls.
The Quality Team members (i.e. ‘QA Inspectors’) working under the Quality Manager are part of an organisation adjudged competent to carry out QA duties.
What are the responsibilities of Staff in an Organisation?
Your Staff are at the sharp end of delivering quality. They are responsible for implementing the QC processes that will ensure the desired level of quality is consistently applied to the product. Of course they are not responsible for setting the level of quality but, so long as they have been clearly briefed on what is required and have received the appropriate training to do the job, they will be capable of delivering that level of quality.
It is vital that a workforce is as committed to quality as the management. A committed workforce will look after your organisation. A workforce who is empowered to implement quality (and are allowed to have an input in defining and improving it) will be highly motivated. Morale will improve as Staff will feel that they are doing a good job that they can be proud of.
In summary, an organisation workforce has the responsibility for:
Working in accordance with the predefined QPs and WIs;
Refusing to accept anything that is substandard;
Having an active role in quality improvement;
Having an input into defining levels of quality (after all, they know better than
Anybody what can be achieved);
Delivering the level of quality specified in the QMS.
In short, your Staff is your greatest asset.
How quality helps during the life cycle of products and services ?
As described earlier, a process is ‘a system of activities, which uses resources to transform inputs into outputs’.
For organisations to function effectively they will not only have to identify and manage a number of interlinked processes, they will also have to incorporate QA into their management system and the life cycle of their products or services.
This ‘life cycle’ basically consists of five separate stages, namely:
The design stage;
The manufacture of a product or the implementation of a service;
The acceptance stage;
The in-service stage;
The end-of-life stage.
Design stage of Product Life Cycle :
‘Quality must be designed into a product before manufacture or assembly’ (ISO 9000). Throughout the design stage of a product or service, the quality of that design must be regularly checked. Quality Procedures (QPs) have to be planned, written and implemented so as to predict and evaluate the fundamental and intrinsic reliability of the proposed design. It is at this time that the proposed design is verified against the customer’s requirements to ensure it will actually deliver the intended functionality.
Throughout the design stage the quality of that design must be regularly checked. QPs have to be planned, written and implemented so as to predict and evaluate the fundamental and intrinsic reliability of the proposed design. It is at this time that the proposed design is verified against the customer requirements to ensure it will actually deliver the intended functionality.
Manufacturing stage of Product Life Cycle :
According to ISO 9001 ‘Manufacturing operations must be carried out under controlled conditions’ During all manufacturing or production processes (and throughout early inservice life), products and services must be subjected to a variety of Quality Control procedures and checks in order to evaluate the degree of quality. These controls will ensure the products and services comply with your predetermined documented requirements.
Acceptance stage of Product Life Cycle :
ISO 9001 says ‘‘The Quality of a product must be proved before being accepted’
During the acceptance stage, the product and/or service is subjected to a series of tests designed to confirm that the workmanship fully meets the levels of quality required (or stipulated) by the user and that the product or service performs the required function correctly. Tests will range from environmental tests of individual components to field testing of complete products. This acceptance stage is generally termed the ‘validation’ phase, where finished products and services are checked to ensure that they comply with the original requirements.
In-service stage stage of Product Life Cycle :
As per ISO 9001 ‘Evaluation of product performance during typical operating conditions and feedback of information gained through field use – improves product capability’. During the in-service stage the equipment or service user is, of course, principally concerned with reliability.
End-of-life stage stage of Product Life Cycle :
Designing, manufacturing, accepting and using products and services is not the full story. Eventually they will come to the end of their useful life either through age, fault or, more than likely (because it has been designed and/or built to such a high degree of quality!), it has been overtaken by technology. Before throwing the redundant piece of equipment onto the rubbish heap, however, it is essential that a fully documented historical record, of its design, use, problems, advantages and disadvantages, etc. is assembled. So, if you can incorporate quality into all five stages within the life of products and services, then you can have total control over your own successor failure!