Quality Risk Management — How Much Evidence Is Enough on Temple Quality in Pharma Course

FMEA in Detail — Scoring, Scaling, and Where It Breaks

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

RPN is a prioritization tool, not a measurement. It tells you which failure mode to look at first — it does not tell you how much worse one failure mode is than another, and treating it like it does is the single most common way an FMEA goes wrong.

Fault Tree Analysis — Working Backward From a Failure

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

FMEA asks, before anything has gone wrong, “what could fail in this process?” FTA asks, after something already has, “what chain of causes could have produced exactly this failure?” They run in opposite directions through the same failure space, and a mature quality system uses both.

Mechanics

A fault tree starts with a single, precisely defined top event — the failure that occurred — and branches downward through logic gates to the conditions that could produce it:

HACCP — Critical Control Points, Borrowed From Food Safety

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

Instead of scoring every failure mode in a process, HACCP asks a narrower, sharper question: where in this process is a critical control point — a step where losing control means the hazard reaches the patient, with nothing downstream left to catch it?

Mechanics

HACCP originated in food safety (developed for NASA’s manned space program, to guarantee astronaut food had zero tolerance for contamination) and maps cleanly onto sterile and biologic manufacturing, which share that same “no downstream catch” property. The full method has seven principles; the ones that matter for a control-strategy discussion are:

HAZOP — Deviations From Design Intent

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

HAZOP doesn’t start from a list of known failure modes the way FMEA does — it starts from the process’s own design intent and systematically asks what happens if reality deviates from it, one guide word at a time, parameter by parameter.

Mechanics

For each parameter at each step of a process (flow rate, temperature, pressure, pH, concentration, time), a HAZOP team applies a fixed set of guide words and asks what a deviation of that kind would actually cause:

Risk Ranking and Filtering — Comparing Risks That Don't Share a Scale

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

FMEA scores risks within one process on one shared scale. Risk ranking and filtering compares risks across processes, products, or sites that have no natural shared scale at all, by explicitly defining and weighting the criteria that make one risk matter more than another.

Mechanics

Define criteria that matter across every risk being compared — typically patient impact, regulatory exposure, likelihood, and detectability, though a portfolio-level exercise might add business impact or timeline pressure.
Weight the criteria to reflect what actually matters most in this decision (patient impact usually carries the most weight; timeline pressure usually carries the least, if it’s included at all).
Score each risk against every criterion, using whatever scale is practical (often 1–5, sometimes qualitative bands converted to numbers).
Compute a weighted score and rank — then filter: set a threshold or a headcount/budget cutoff and act on what clears it, explicitly documenting why anything below the line is being deferred.

The “filtering” half is as important as the ranking half — the exercise exists to produce a short, defensible action list, not just a long sorted table nobody acts on.

Ishikawa / Fishbone / PHA — Structuring the First Pass

Sat, 12 Sep 2026 00:00:00 +0000

The one idea

An FMEA is only as complete as its failure-mode list, and that list has to come from somewhere. Ishikawa (fishbone) diagrams and Preliminary Hazard Analysis are how you brainstorm it systematically, category by category, instead of relying on whoever’s in the room to remember everything from experience.

Mechanics

An Ishikawa diagram starts from a defined effect (an observed or feared problem) and branches into standard categories of contributing cause. Adapted for an analytical lab, the categories are usually: