Frequently Made Errors in Documenting a QMS

Documentation, being laborious and time consuming, has been mistakenly taken to be the heart of the
quality management system (QMS).

But in actual sense it is a support activity that:
~ Ensures that there is a record of what the planned activities are and a check point against which to
assess the practice;
~ Provides consistency and continuity in the way work is carried out;
~ Moves the company away from dependence on individuals to dependence on systems;
~ Provides traceability and transparency;
~ Provides a description of the system;
~ Serves to train staff in the workings of any organization.

The documentation in a QMS comprises:

a) the Quality Manual:
which ideally provides a brief description of the QMS ie: the quality policy of
the organization, the objectives which support the quality policy, the various processes (major activities),
their interconnectivity and the organizational structure. The quality manual usually makes reference to
the detailed procedures.
b) the Procedures: which describe all the processes (the major activities) in the organization, how they
are carried out, the people responsible and controls within each process ie: they describe ‘the WHAT is to
be done, HOW is it to be done and WHO is to do it’ of each activity in the organization;
c) the Work Instructions: these complement the procedures by providing more guidance on specific
activities;
d) the Quality Plans: these are usually specific to a product or service and usually lay down the specific
inspection and control activities to be done to ascertain that the product or service meet the desired
specifications;
e) Records: these provide documented evidence that all activities have been carried out according to
the laid out plans;
f) Job Descriptions: These provide a description of the roles and responsibilities of all personnel within
the organization.
In writing the quality manual there is the tendency to repeat what has been written in the ‘International
Standard’ eg:
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a) identify the prcesses needed for the quality management system and their application throughout the
organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring
of these processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
Taken from ISO 9001:2000
Above is clause 4.1 of ISO 9001:2000. In writing the quality manual, compliance with the requirements in
this clause could successfully be done using a flow diagram or process map both of which are effective
ways of showing the processes, their sequence and interaction. What is commonly done is shown below:
4.1 General requirements
ABC Electronics Ltd has established, documented, implemented and is maintaining a quality management
system and shall continually improve its effectiveness in accordance with the requirements of the
International Standard.
ABC Electronics Ltd has
a) identified the processes needed for the quality management system and their application throughout
the organization (see 1.2),
b) determined the sequence and interaction of these processes,
c) determined the criteria and methods needed to ensure that both the operation and control of these
processes are effective,
d) ensured the availability of resources and information necessary to support the operation and
monitoring of these processes,
e) monitored, measured and analysed these processes, and
f) implemented actions necessary to achieve planned results and continual improvement of these
processes.
The problem with the above statement is that it does not answer the question of ‘HOW’ the organization
is complying with the clause.
Another mistake commonly found in documentation is partial documentation ie: what has been
documented is less than what is being done. An example is the sales function whose key role is securing
business for the organization.
Along side this, the department may be responsible for credit control and debt collection. In most cases,
you will find that the sales activity is detailed in the procedures but no mention is made of how the credit
control and debt collection functions are undertaken by the same department.
There is also the tendency to document the ‘desired situation versus what is on the ground’. In cases
such as these the documents usually show what the organization would like to happen, however, what is
on the ground is usually quite different.
Another error usually found in documentation is the tendency to describe in detail what is done without
paying attention to the requirements of the International Standard. See the example below:
ISO 9001:2000 Requirement
The organization shall evaluate and select suppliers based on their ability to supply product in accordance
with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be
established. Records of the results of evaluations and any necessary actions arising from the evaluation
shall be maintained (see 4.2.4)
Extract from a Company Procedure developed in Response to the above Requirement
The selection of suppliers will be the responsibility of the person raising the requisition.
Payment to the supplier will be made on the recommendation of the requisitioner.
ISO 9001 requires that the company maintains a list of approved suppliers who have to be evaluated
against established criteria as may be seen fit by the organization. Examples of criteria include: delivery
time, price, quality, etc.
Therefore the procedure must mention the criteria used for evaluating the suppliers, frequency of
evaluation, records arising from the activity and make reference to the list of approved suppliers. But
instead of this the company may decide to do what is shown in the extract.
Some times companies fail to provide unique identification for the documents. Unique identification can
be in the form of unique titles, numbers with other codes signifying the company name and originating
department of the document. Unique identification ensures that there is ease of traceability.
Good documents must provide for amendments. Anybody who has had a chance to look at the way the
law is written will have seen that in the extreme left or right there is always small writing showing the
paragraphs which have been repealed.
This is one way of showing the amendments that have been made to the law. Likewise in the quality
management system there must be a provision for making amendments to the documentation.
This may be a page at the end of each document with a table in which you can write the date, the
amendments made and the approving authority. Tracking changes to documents can be simplified further
by numbering paragraphs and lines. This way when a change is made then reference is made to the
affected paragraph and line.
Sometimes companies fail to indicate the revision status of documents. Like publications which indicate
the revision status by showing on the cover 1st, 2nd or 3rd edition, the QMS documentation must show
the number of times the documents have formally been revised.
This is what the revision status is all about and it prevents potential users from using the wrong version
of the documents.
If the documentation process is done carefully, then the benefits of the QMS are visible to all. If it is not,
then the phrase commonly used for computers ie: garbage in, garbage out, can be used in the case of
this QMS.

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