August 2014

Quick Guide to Fishbone Diagram

1. Construct Fishbone diagram (for example, use flip chart paper, MS
Excel, MS Visio)

Manpower Method 2. The Head of the fishbone is the problem being addressed (e.g. plate
Aseptic
contamination)
Coat / gown Water in tubing
Spines
Water in tubing connections
sets procedures sets
Hoods back Storage of Movement of
Staff movements
Cleaning
cleaning
materials under
kettles / preps 3. Brainstorm possible cause of the problem
Handling procedures sink in prep Materials on top
for plates Materials on top of onlines
Coat / gown
4. Record ideas on the appropriate Spine of the fishbone diagram (the
of onlines
Stacking plates outside procedures Slicone spray
HEPA
Staff movements Cleaning
Hoods back Handling procedures Movement of cages same idea can go on more than one Spine):
for plates inside clean room
Stacking plates outside Cleaning regime
HEPA
Staff movements
- Pouring to prep
Hoods back
Deep clean – lack of
Head Method
Validation
- Packing to
pouring
Movement of waste -Autoclaves
-Media preps
Standard Work, SOPs, policies, regulations
Manpower
Infrequent
Gaps in hoods -Onlines
handwashing
Cleaning regime -Cleaning

Environment
Plate People involved in the process
contamination
Air quality Online crashes
Holding times resulting No. cages
Machine
Online HEPA cleaning
Cracked hoods
Preventive maintenance
- media prep
from delays
Paper / cages / clutter
Cleaning regime Computers, tools, equipment employed
Cracked hoods
Paper / cages / clutter
- Online
-HEPA Gaps in hoods Movement of waste Petri dishes Material
Air quality -Cleaning Hoods back Water in tubing

Movement of
sets Raw materials, parts, pens, paper, etc. used
AES preps
Environment
Spines Validation
-Autoclaves The conditions, such as location, time, temperature, and culture in
-Media preps
-Onlines
-Cleaning
which the process operates
Machinery Material
5. Look for concentrations in one area

6. If there is more than one concentration use a Quick Vote to

General Points determine which are the most important.
•Fishbone is used to collate brainstorm ideas – you still
need data to verify 7. Deliverable = a list of Potential causes which require verification with
•Use cross functional teams where possible Data.
•Mandatory PPI tool used in Step 4.
•Also called Cause and Effect Diagram