Troubleshooting vs Test Failure

GOOD VALIDATION PRACTICE (cGVP) PURIFIED WATER VALIDATION
1

Hi!
What´s the different between Troubleshooting and Test Failure? :confused:
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)?

WHO
Technical Report Series 929
thirty-ninth report
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
daily.
• Develop appropriate operating ranges.
• Develop and finalize operating, cleaning, sanitizing and maintenance
procedures.
• 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.

2

According to that guideline I think you should get acquitted with the system and its possible failures before you do the test. then whatever failure accurs during that time you should use it in you “troubleshooting” SOP, also evaluate other possible failures in the system and the proper action to correct it. Once you have this down you can run your 2-4 weeks run test, and during this there should not be any system failure. Finally, document it so. You may keep refining you SOPs until you have cover all possible paths. I hope this helped.