What´s the different between Troubleshooting and Test Failure?
Do we use both terms for the same thing? or
Is troubleshooting applicate for water systems and test failure is for quality of the product (water)?
Technical Report Series 929
Annex 3. WHO Good Manufacturing Practices: water for pharmaceutical use
Phase 1. A test period of 2–4 weeks should be spent monitoring the
system intensively. During this period the system should operate
continuously without failure or performance deviation. The following
should be included in the testing approach.
• Undertake chemical and microbiological testing in accordance with
a defined plan.
• Sample the incoming feed-water daily to verify its quality.
• Sample after each step in the purification process daily.
• Sample at each point of use and at other defined sample points
• Develop appropriate operating ranges.
• Develop and finalize operating, cleaning, sanitizing and maintenance
• Demonstrate production and delivery of product water of the
required quality and quantity.
• Use and refine the standard operating procedures (SOPs) for
operation, maintenance, sanitization and troubleshooting.
• Verify provisional alert and action levels.
• Develop and refine [COLOR="#FF0000"][COLOR="#FF0000"]test-failure [/color][/color]procedure.