In case the water does not meet the specification/Action limit repeat other corrective action plan as applicable and proceed till test results compliance with specification. Also take up the following:
- Consult the water system plant manufacturer
- Analysis and assess the source water quality
- Review of the total water system performance and test results of previous month Investigation
When initiate for detailed investigation as per the check points described below:
- Check the water system plant operational parameters
- Check for defects in water system components
- Check the preventive maintenance records
- Check the on line conductivity
- Check the pressure drop of on line pressure filters
- Check the flow rate of water
- Check the UV lamp efficiency from records
- Check the last sanitation records
- Check the chemical analysis data of that day
- Check the last microbial check results for that sampling location
- Check the microbial test results of other sampling locations (same day / previous week)
- Check the sampling method, sampling container
- Check the analytical method
Discontinue further use of water for product requirement. Investigation by Quality Department (Both by QA & QC) carried out and compile the investigation report and assess for the most probable reason.
- Plan and execute the corrective action plan based on the investigation
- Re sampling and re testing
- Replacement of defected water system component
- Sanitation of the line
- Regeneration of the water plant Monitor the implementation of proposed corrective action plan.
- Re sample from the same sample location after corrective action, retest and assess the test results.
If the results meet with specifications / proposed action limit continue the collection of water as per the requirement. Amend the monthly routine monitoring plan for water system (If required) through change control system.
Review of Product(s)/Batch(s) for any possible risk on quality before making the final release. Review and amend the preventive maintenance program of water system (If required) through change control system.
Action path followed for test results exceeding the action limit is depicted in flow diagram. Follow the similar procedure for action plan in case of test results exceeding alert limit except with exclusion that further use of collected water may be continued for the product requirement.