Qms Implementation: Establishing A Quality Management System (4.1)
Qms Implementation: Establishing A Quality Management System (4.1)
The cycle commences with the Organization’s purpose from which are developed objectives.
In planning to meet these objectives the processes are identified and their sequence and
interaction determined. Once the relationship between processes is known, the
criteria and methods for effective operation and control can be developed and documented.
Before implementation the processes need to be resourced and the information necessary to
operate and control them deployed and brought under document control. Once operational the
processes need to be Monitored to ensure they are functioning as planned. Measurements
taken to verify that the processes are delivering the required output and actions taken to
achieve the planned results. The data obtained from monitoring and measurement that is
captured on controlled records needs to be analysed and opportunities for continual
improvement identified and the agreed actions implemented.
All organizations have a management system – a way of working, but in some it is not
formalized – in others it is partially formalized but not effective and in a few organizations the
management system really enables its objectives to be achieved year after year.
Improvements in conformity during operation of the system arise through enforcing policy
and practices – doing what you say you do
_ Improvements in conformity during system construction arise through enforcing policy and
design rules on the system – reworking the system to comply with the established policies and
objectives
_ Improvements in efficiency during system construction arise through finding better ways of
implementing the system design – shorter, less wasteful routines, less complexity, lower skill
levels, fewer resources
_ Improvements in effectiveness arise as a result of identifying different policies and
objectives – higher targets, new objectives, new requirements, regulations, and new
technologies
Process installation
Process installation is concerned with bringing information, human resources and physical
resources together in the right relationship so that all the components are put in place in
readiness to commence operation.
Therefore a precursor to process installation is the preparation of sound foundations. Everyone
concerned needs to understand the purpose and objectives of what is about to happen – they
all need to perceive the benefits and be committed to change and understand the concepts and
principles involved.
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QMS IMPLEMENTATION
A common failing with the implementation of documented practices is that they are not sold
to the workforce before they become mandatory.
The process of installing a new process or one that requires a change in practice is one that is
concerned with the management of change. It has to be planned and resourced and account
taken of attitudes, culture, barriers and any other resistance there may be (Juran, J. M., 1995)
Process commissioning
Process commissioning is concerned with getting all the new processes working following
installation. The people will have been through reorientation and will have received all the
necessary process information. Any new resources will have been acquired and deployed and
the old processes decommissioned. Installation and commissioning of new processes take
place sequentially usually without a break so that current operations are not
adversely affected.
Process integration
Process integration is concerned with changing behaviour so that people do the right things
right without having to be told. The steps within a process become routine, habits are formed
and beliefs strengthened. The way people act and react to certain stimuli becomes predictable
and produces results that are required. Improvement does not come about by implementing
requirements – it comes about by integrating principles into our behaviour.
System integration
System integration is concerned with making the interconnections between the processes,
ensuring that all the linkages are in place and that the outputs from a process feed the
interfacing processes at the right time in the right quality. The system will not be effective if
the process linkages do not function properly.
The standard requires the organization to identify the processes needed for the quality
management system and their application throughout the organization.
Processes produce results of added value. Processes are not procedures (see Chapter 2 on
Basic Concepts). The results needed are those that serve the
organization’s objectives.
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QMS IMPLEMENTATION
From the organization’s mission statement determine the factors upon which
accomplishment of the mission depend – these are the critical success factors
(CSF). The CSFs indicate the capabilities needed and consequently identify the
processes required to delivery these capabilities . Now, analyse each core process and identify
the key stages from input to output in order to identify the key sub-processes. Decomposing
the layers further, by analysing each sub-process will identify the work processes and
eventually the tasks performed by specific individuals. This is as deep in the hierarchy that
you should need to go.
A process that delivers the required quantity of outputs that do not possess the required
characteristics, are delivered late, waste resources and breach policy and safety,
environmental or other regulations is not effective.