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RCA Fishbone

The document lists risks of non-compliance related to people, equipment, environment, materials, products, and methods/procedures. It includes factors like mistakes, inadequate training, faulty equipment, improper storage, and deviations from specifications.

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vaibhav gosavi
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113 views1 page

RCA Fishbone

The document lists risks of non-compliance related to people, equipment, environment, materials, products, and methods/procedures. It includes factors like mistakes, inadequate training, faulty equipment, improper storage, and deviations from specifications.

Uploaded by

vaibhav gosavi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ROOT CAUSE ANALYSIS

List of the risks of non-compliance

MANPOWER MEANS MEDIUM


PEOPLE EQUIPMENT ENVIRONMENT
1 2 3

3.1---- physical working conditions (noise, temperature, lighting, tidying …)


3.2---- relational working conditions (working atmosphere, urgency ,
2.1 ---- manufacturing, packaging and/or hierarchical relationship , coworkers relationship, counter order….)
1.1---- mistake, omission analysis equipment & their
confusion, carelessness, 3.3--- manufacturing, packaging, sampling workshops, warehouse, laboratory
instruments of control: calibration, environment : temperature , humidity , light , Tidying…
negligence. qualification, maintenance
1.2---- numbers (adapted 2.2 ---- other associated control equipment
to the job) NON-COMPLIANCE :
like: weighing machine, pH meter, …
1.3---- medical aptitude 2.3 ---- utilities equipment for compress air, A. Confusion
1.4 ---- training, know-how, steam, water , electricity : adequate
ability, certification capacity, calibration, qualification, B. Wrong or missing printing
1.5---- technical, GxP rules , safety, C. Wrong quantities
maintenance …
knowledge
D. Wrong component
E. Deviation in the manufacturing
operation
F. Non-compliance to the
specifications of the Marketing
5.8---- Utilities: water , steam , Authorisation: activity, aspect,
electricity, compressed air ,… purity, stability
5.7---- sample for control
5.6---- finished products after release G. Other deviation
5.5---- finished product before release 4.8---- SOP’s describing processes
5.4---- Semi-finished products before the 4.7---- organization SOP’s
secondary packaging 4.6---- storage instructions
5.3---- Bulks before the primary packaging 4.5---- process, cleaning, analytical validations
5.2---- On-going products at the preparation 4.4---- analytical instructions
6.3---- analytical trend analysis 4.3---- SOP’s/instructions of use of equipment
5.1---- Raw materials, process water ,
6.2---- calculation 4.2---- instructions of packaging, manufacturing, cleaning
packaging materials.
6.1---- quality of data . 4.1---- instructions of reception, sampling

MEASURES MATERIALS METHODS


TESTS PRODUCTS PROCEDURE
6 5 4

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