Best Practices in Statistical Process Monitoring ... - IBC Life Sciences

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4. How to Define “Out of Trend” ● Variation not explained by a single distribution of process output 1 ● Violation of the Western Electric or Nelson trending rules 2 ● Result from a process not associated with random variation ● Visual review .. .outside 3 …discretion of lab management ● Can vary by site or group within site (i.e. QC vs. manufacturing) …Consensus on +/- 3 limits… but from what data set 1. MJ Kiemele et al. Basic Statistics: Tools for Continuous Improvement.4 th Edition 2. NIST/SEMATECH e-Handbook of Statistical Methods, http://www.itl.nist.gov/div898/handbook / 04MAY2011
5. How and When to Define Control Limits ● Choose right reference data set… – After ~15-30 batches from stable process (Shewhart recommends 25+) – Use interim provisional limits from process validation criteria – Use largest dataset representative of current process & testing ● Exclude Outliers… – Remove known root (special) causes – Use objective outlier exclusion methods – Use judgement -> tighter limits (conservative, defendable, appropriate) – Show outliers even if excluded from calculations ● Revisit/adapt when needed… – When known process or analytical change impacts mean or variability – As APR recommendation or in change control – Can shift mean but retain long term variance
Page 1 and 2: IBC Process2Product Oct 4 th , 2011
Page 3 and 4: Origins: BPOG Data Analysis Working
Page 5 and 6: SPC Driver - FDA Validation Guidanc
Page 7 and 8: Goals of Effective SPC Program ●
Page 9 and 10: 1. How to Choose which Variables to
Page 11 and 12: 2. How to Respond to OOT Signals: P
Page 13: 3. How to Manage OOT Response Team
Page 17 and 18: 7. When & How to use Western Electr
Page 19: Summary: Key Success Factors in SPC

Best Practices in Statistical Process Monitoring ... - IBC Life Sciences

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