ied limit. Relevant authorities need to be informed Significant discharge, resulting in a fine or restriction of operating license Level Score 1 2 Severity Description No Effect Medium 3 High 4 Continuous Equipment used on occasional basis Equipment is required to function independently for up to 50 % of the time. Equipment required to function as part of a continuous process for a proportion of the planned production time Equipment is required to function continuously24:T4d1,Criticality Assessment Health & Safety Quality Engineering Costs 1. No Effect 2. Visit to Health Centre 3. Minor injury 4. Lost time injury 5. Major injury 6. Single fatality 7. Multiple fatalities 1. No effect 2. Some Effect/ deviation 3. Lower grade material 4. Material to be re-worked 5. Reject Material produced 1. < £500 2. < £2000 3. < £10000 4. < £20000 5. > £20000 Environment GMP Waste or Energy Loss 1. No effect 2. Investigation 3. Complaint Breach of regs 4.Major breach of regs 5. Business interruption 1 day 6. Bus. interruption 1 week 7. Bus. Interruption 1 month 1. Not GMP 2. Product contact only 3. Production delay only 4. Detectable failure 5. No obvious failure 1. No waste or energy 2. Minor waste or energy 3. Moderate waste or energy 4. Major waste or energy Output Time to Repair 1. No effect 2. Minor Delay < 1hr 3. Plant down <12 hrs 4. Plant down > 12 hrs 5. Catastrophic > 1 week 1. No effect 2. < 1 hour 3. < 6 hours 4. < 12 hours 5. > 12 hours Utilisation MTBF 1. Equipment used occasionally 2. Work upto 50% of time 3. Considered a bottle neck 4. Req.’d upto 90% of time 5. Req.’d uptp 100% of time 1. > 3 years 2. > 1 year 3. > 6 months 4. > 1 month 5. < 1 month Example25:T682,0 Linea BE: GRANULATORE GLATT 1 Linea ZB: BASSINA GS-150 1 Linea GB: REATTORE Linea BM: COMPATTATORE -GERTEIS KANEBO GRANULI Linea H10 Fig. 1: Diagramma del TEFS e di Pareto (PHARMA) Linea H38: BLISTERATRICE IMA Linea H4 Linea GE: GUEDU' Linea Hm11 C 320.000 80% 280.000 70% 240.000 60% 200.000 50% 160