Control of processes
Production and service should be planned and implemented under controlled conditions this means:
- product requirements
- works instructions
- suitable / maintained equipment
- monitoring and measuring devices and techniques with suitable training
- final inspections / checks tests, delivery and other post delivery support / returned goods
- actions to minimise human error (see risk assessment)
Validation of processes – what??
Your must validate any processes where what you make cannot be verified. This might be where deficiencies only come to light during the use of the product. Validation should demonstrate these processes are capable of producing the desired results. Where this is the case (and there are very few, most people should exclude this item) you should define:
- review and approval of processes
- suitable resources (people / equipment / environment)
- methodology (trained people)
- records to be retained
Identification and Traceability
You must be able to trace a product through production to delivery at every relevant stage / process including it’s status and any testing it has undergone. Where appropriate this should include record of which measuring equipment tested in case of faults in the equipment discovered after the fact. This may well include the use of product ID, batch numbers or serial numbers to the required level of detail
Customer / external providers property
Your company must exercise care of a customers property (be it drawings, data, personnel, environment (property or IT), intellectual. This includes identifying, verifying, protecting and safeguarding it. Records shall be maintained and the customer reported to if it is lost, damaged, stolen or unsuitable.
Preservation of Product
Your company shall suitable (be sensible) preserve product during processes and delivery including handling, packaging, storage and protection. This will obviously marked vary according to which type of property it is.
Post delivery activities
This can often be a service in itself, think service contract, SLAs, warranties, guarantees – ensure these are controlled, measured, monitored, reviewed and actions taken to ensure both conformity and improvement
Control of Monitoring and Measuring Devices
If you use calibrated equipment (or in the case of software testing for example test harnesses / rigs) it must be:
- calibrated / verified at specified intervals or prior to use against any relevant standards.
- adjusted as necessary
- identified to establish when it will require recalibration to prevent
inadvertent use of inaccurate equipment
- stored and used in such a way as to prevent mis-alignment of the equipment
As in the design and product realisation processes, if equipment is found to be faulty, your company must keep enough
records to recheck previously checked goods. Or be able to re-assess previous results and take actions both corrective and preventive.
Records of results of calibration should be maintained.
Where using computer software, its ability must be confirmed prior to initial use and
reconfirmed as necessary.
This may well include anti-virus software