DATA  TRENDING

When your company team develops non-conformance / complaint / CAPA trend charts (usually from a spreadsheet), they'll need to ask the following questions and determine how to present and label / categorize the data presented so it can be acted upon (the key reason for collecting / trending in the first place):

• Frequency - generally monthly presentations and also showing yearly for the bigger picture;
• Areas charted, and Categories within each chart - should be based on risk of problem to the end-use / patient as no. 1, with business / financial / GMP compliance issues also important, but secondary;
• Is all the above structured and presented to assist in getting to root causes, and addressing and eliminating the problem in a timely manner;
• Is all the above designed to show resolution / effectiveness (e.g., a decline in the number of occurrences of each area / category) ;
• How will each chart be presented to senior management; how will action be taken on each / triggers (monthly Alert at 1.96 sigma (annual); monthly Action at 3.0 sigma (annual), or ...); how will such action(s) be documented monthly (a Trend Meeting, Agenda, and Minutes?).

These (and possibly other) issues are what the CGMPs, especially CAPA (see 21 CFR 820.100 and note a.1-7) and the Trending requirements are driving.  The FDA (and any QMS, i.e., ISO 13485) want companies to have quality systems in place that recognize system and product / supply chain / manufacturing / testing problems, highlight those problems (trending is part of this), and force / drive change (verified / validated / monitored for effectiveness) to eliminate those problems, then move on to the next inevitable group of problems. A proactive problem-solving system. 

-- jel@jelincoln.com

Note:  In calculating standard deviation for the Alert and Action levels, you should have approx. 100 data points before making that calculation, not use the monthly totals data for that calculation. JEL 06/01/2022