Process Failure Mode and Effects Analysis

Subject Drilling for capsule

(2) Structure Analysis (3) Function Analysis

Process Process Process Process
Issue Item Step Work Element Item
Drill four holes for Spot face four hole
1 capsule positions Spot facing tool Spot face

Drill four holes Drill, drill bits Drill holes

Shingo, Shigeo. 1986. Zero Quality Control: Source Inspection and the Poka-Yoke System. Productivity Pr
tion Analysis (4) Failure Analysis
Step or Product Work Element or Failure Failure
Characteristic Process Characteristic Effect (What?) S Mode (How?)
Fixture part and
lower drill press Drill press, spot facer

Fixture part and

lower drill press Drill press, drill bits Hole(s) not drilled 5 Drill bit breaks

d the Poka-Yoke System. Productivity Press pp 80-81

 Note: formal FMEA includes additional c
responsibility, target date, and status
(5) Risk Analysis (6) Optimization
Failure Prevention Detection Action
Cause (Why?) Control O Control D Priority Prevention

Worker unlikely to
Radial forces, notice, will not be
excessive torque, detected in current
small bit diameter None 10 process 9 H None
mal FMEA includes additional columns for Note: formal control plan includes additional headers and a couple of column
bility, target date, and status Note also that process name could be redundant with process item, and the
Control Plan (added as a Dynamic Control Plan
Revised Characteristics
Detection S O D AP Process name Equipment Process
Spot facing and Tool speed, feed
drilling Spot facing tool rate

Jidoka/
autonomation stops
the tool, notifies
the worker, and
does not allow the Spot facing and Multiple (4) drill Tool speed, feed
part to leave 3 10 3 M drilling press and drill bits rate
 ers and a couple of columns
with process item, and the control is redundant with the information in the PFMEA

Requirements/ Measurement/ Sample size

Product Specification Evaluation and frequency Control

Four spot facings

Jidoka/
autonomation stops
the tool, notifies
the worker, and
Diameter upper and Small hole gages does not allow the
Four holes lower specifications (go/no go) Every nth part part to leave
 Reaction Plan

Replace broken drill

bit, re-drill the part