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A Quality Management System (QMS) is a system of “doing things” so that the organisation maintains quality at all levels and is responsive to customer complaints and product failures.
What this means is that every organisation will have a company manual which describes the organisation and every process in it. Employees within the organisation will always know exactly what must be done for every possible scenario.
The vision of the organisation is broken down into specific operational objectives. These functions are then broken down again into a range of processes. Processes are then further analysed and broken down into procedures. Procedures are simplified into work instructions. Work instructions are the simplest form of instruction in an organisation and tell the individual worker exactly what must be done in his particular job. Work Instructions are underpinned by document templates, charts of measurements, particular tools, gauges, and forms.
A Quality Management System can only function if all the building blocks are in place. It may take several years to refine the building blocks, but they will eventually have to be documented and kept up to date by the Quality Management team.
Quality Management Systems have minimum requirements to be able to be implemented and operated. Certification organisations will also have minimum requirements that organisations must comply with in order to receive the accreditation.
ISO 9001 (2008) for example has a list of minimum procedures that is needed to make the system workable.
Document control refers to a system within the organisation that ensures that all documents are controlled properly. This is often a task left to the Technical Administrator in a small organisation. In larger organisations a Documentation Control Officer will manage the documents.
The Document Control Officer will see to the correct titles, document numbers, revisions and updates and proper issue to the correct recipients. The Document Control Officer does not normally write documents but needs to know the correct process for writing – reviewing – authorisation and release of documents.
Quality System record keeping is important for the Quality System auditing process.
Certification organisations will audit the organisation and determine whether the quality system is up to standard or not. The only way they can really do this is to see the quality records and check the records against the performance of the personnel.
The keeping of records may also be part of the Document Control Officer’s job.
At pre-set intervals, the entire system must be audited. This means that the Quality Manager must check a number of systems to ensure that they are meeting the standards required.
Where products are manufactured, it does happen that some of them are not entirely perfect. The ISO system requires that these imperfect products are detected by means of a process. Once the defective product has been detected, there must be some means of managing the non-conforming product.
This is normally a process which sees the product removed from the production line and sent to some testing environment. Suitable reports are generated and sent to two “next steps” in the process. These are the Corrective Action and the Preventative Action processes.
Corrective action is a process that ensures that the faulty product either doesn’t continue in the production line, or in the event that the product does continue and is passed to the customer, there is a means for the customer to tell the company and return the product.
Preventative action ensures that measures are taken so that the faults in the product are not allowed to happen again. This might include additional steps in the final testing phase but more likely will include minor redesign of processes earlier in the product phase so that the fault does not re-occur.