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Clause 4.1;Management Responsibility
1. Establish a quality policy
2. Ensure that the policy is understood, implemented and maintained
at all levels
3. Define responsibility, authority and how assignments are
interrelated.
4. Identify and provide adequate resources
5. Appoint a management representative
6. Provide for the management review of the quality system
to ensure its
effectiveness
Clause 4.2;
Quality System
1. Outline the structure of the documentation in the quality
manual
2. Formulate procedures, work instructions and formats for
records
3. Prepare a quality plan for each product and service
4. Effectively implement all the above
Clause 4.3;Contract Review
This clause provides for the following:
1. A review of each order, contract or tender to ensure that
the requirements are defined and documented,
and that there is a capability to meet these requirements
2. The establishment of review and amendment procedures
3. That records of contract reviews are kept
Clause 4.4;Design Control
This clause covers;
1. Design and development planning
2. Identification and allocation of resources
3. Organisational and technical interfaces
4. Definition and control of design inputs, outputs and interfaces
5. Design verification
6. Design validation
7. Review, approval, recording and control of design changes
This clause may be excluded if ISO-9002
certification is sought because customers or collaborators
give designs.
Clause 4.5;Document Control
Includes
1. Review and approval of documents by authorized persons
2. Making available the updated versions of necessary documents
at appropriate locations
3. Removal of obsolete documents
4. Authorisation and recording of changes to documents
Clause 4.6; Purchasing
This clause requires:
1. The assessment of subcontractors and monitoring their performance
and capability
2. Keeping records of acceptable subcontractors
3. Formal written definition in the purchase order of requirements
and specifications
4. Verification of the purchased product by the customer,
if required in the contract
Clause 4.7;
Control of customer-supplied product
If the customer supplies something that will become part of
the final product or service, there must be a procedure to
ensure that it is acceptable and remains fit for the purpose
for which it is intended. e.g., clothes in a laundry, the
car in a repair shop and such.
Clause 4.8;
Product identification and trace ability
Where the customer or the firm needs product or component
parts to be identified or traced, the methods to be used and
records to be kept should be identified. The reasons for requiring
identification and trace ability may be varied. Some applications
are described below:
In the clothing industry, material from the same dye lot
is usually processed as a batch to avoid colour mismatch.
In the pharmaceutical industry, the batch number of each
lot of drugs manufactured must be traceable to the date of
manufacture, the source and quality of raw materials used
etc.,
Clause 4.9; Process control
In brief, process control requires a firm to:
1. Identify and plan its processes
2. Use suitable equipment and set up an adequate processing
environment
3. Prepare work instructions, where their absence would adversely
affect quality
4. Comply with reference standards and quality plans
5. Monitor key characteristics and features during production
6. Approve processes and equipment as required
7. Establish criteria for workmanship (by way of samples,
illustrations etc.)
8. Establish suitable equipment-maintenance procedures
9. Maintain records on qualified processes and personnel
Clause 4.10;
Inspection and testing
Firm to identify requirements for verification of incoming
goods, in-process semi finished goods and for finished goods
and install procedures for such verification At all stages
to ensure that the end-product/service is capable of meeting
customer's requirements. Records of inspection must be maintained.
Clause 4.11;
Control of inspection, measuring and test equipment
If inspection, test and measuring equipments are used, they
will have to be controlled, stored and used properly, and
their accuracy maintained at the level needed.
To make sure that such equipment operates effectively and
gives reliable results the firm needs to:
Ensure that it is looked after, and is regularly calibrated
and adjusted as needed
Describe how this is to be done and how it is to be recorded.
Calibration should be traceable to national standards. The
records should at least show when the equipment was last calibrated;
who did the calibration; what were the acceptance criteria;
what the result was; its acceptability and how this affects
the suitability of the equipment; calibration status and when
the next calibration is due. The length of the periods between
calibrations depends on the type of equipment, its usage and
how critical the measurements are to the process.
Ensure that it is possible to identify which equipment has
been calibrated and that it is suitable for use (e.g., label
the equipment).
If the equipment is found to be faulty, the validity of
earlier checks using that equipment must be reviewed, and
appropriate action taken
Clause 4.12:
Inspection and test status
This clause requires that it should be possible to identify
quickly:
Whether the required inspections/ tests have been satisfactorily
completed; and
If the product is ready to pass to the next stage or to
be despatched.
One could use markings, labels, tags or physical location
etc.
Clause 4.13:
Control of nonconforming product
It is required to establish ways of identifying nonconformity,
deciding what to do about it and, where possible, keeping
the nonconforming product separate from acceptable products.
It is also required to keep records as to the manner of dealing
with nonconformity to show what happened along the way and
any decisions made. Everyone affected by the problem needs
to be kept informed of what happened.
Clause 4.14:
Corrective and preventive action
This is a vital clause in the standard, which, if followed
scrupulously, leads to continuous improvement of the system
with its attendant benefits.
It is important to understand the difference between the following
concepts:
Disposition of nonconformity (or fixing a nonconformity)
This is about removing the problem (or improving the product)
by repair, rework or other ways described in clause 4.13.
Corrective action. This is concerned with finding out why
the nonconformity occurred and making sure that the problem
does not recur.
Preventive Action. This is about predicting the likely occurrence
of a problem (nonconformity) and taking action to prevent
it.
Thus both corrective and preventive actions lead to quality
improvement. This clause requires procedures for corrective
and preventive actions to identify the persons responsible
for authorizing and for carrying out those actions. Corrective
action may spring from:
Customer complaints;
Nonconformity;
Rework or repair; and
Audit reports.
Triggers for preventive action include:
Market surveys;
Sales figures;
Suggestions from employees;
Audit reports; and
Quality records.
Taking preventive action may bring out the need to change
the quality manual, procedures, work instructions, etc. and
to take up preventive action reports in management review
meetings.
Clause 4.15:Handling,
storage, packaging, preservation and delivery
Procedures are to be drawn up for the above throughout the
process as well as until customer receives the product or
service in good condition fit for use.
Clause 4.16:
Control of quality records
The firm needs to keep records to show that the required controls
have been applied and that customer requirements have been
met. The following should be provided for in the procedure
for record keeping:
Retention time for records;
Storage conditions, retrievability, legibility and identification
Method of disposition when no longer required.
Clause 4.17:
Internal quality audit
Qualified internal quality system auditors perform scheduled
periodic audits (independent of their work area) to verify
conformance to the manual, procedures and work instructions
and report findings in writing to auditees and the management
representative so that outstanding nonconformities to the
system are taken up during management reviews and suitable
corrective and preventive actions are initiated.
This activity is a major source of system improvements.
Clause 4.18:
Training
It is necessary to ensure that the training needs of staff
are identified, the necessary training planned and imparted,
and records maintained. The management review, corrective
action and internal quality audits are major sources of information
on training needs.
Clause 4.19:
Servicing
Where after sales service is contractual or implied, there
must be procedures to make sure that the necessary activities
are performed correctly and that reports or records are available
to confirm this.
Clause 4.20:
Statistical techniques
Statistical techniques may have to be employed to assess and
ensure process capability and product characteristics. Applicability
is to be determined and procedures installed for use of such
techniques. This may require specialist advice.
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uality
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