Why use the Quintilian Hexameter?

Deviation drafting of the 5Ws and 2 Hs in the Health industry

« 5W+1H », or « Quintilian Hexameter» is an empirical questioning tool. Although widely used by the English press for the prioritization of information, it is an efficient tool for quality engineers to gather all the necessary information. Facing a deviation, the « 5W+2H » tool allows to define the most important elements, by describing:

In order to demonstrate the « 5W+2H » methodology used in the pharmaceutical industry, let’s take for instance the writing of a deviation, after an event occurred.

On April 18^th, 2019 the quality assurance engineer working for A&B received an email from the Chinese affiliate, to alert him about a non-conformity that has been noticed in April 11^th 2019, after an audit managed by the local authorities. It appears that two batches of medicine « X », produced and commercialised since 8 months, contain the API (active pharmaceutical ingredient) « Y ». The issue is that the dossier for the addition of the API « Y » is not submitted.

By applying the « 5W+1H » tool, the deviation has been scientifically written as follow:

Who: quality assurance engineer received an email from the Chinese affiliate
What: non-conformity on 2 batches of medicine « X » containing API « Y » 
Where: China (Chinese affiliate of A&B)
When: date receipt email: 18/04/2019 - date of detection: 11/04/2019
Why: dossier for the addition of the API was not submitted
How: during an inspection by the Chinese authorities
How many: two batches

A step we could add to this tool: « Why do that? »

This last notion, not mentioned previously, is an element that turns out to be important in this case. It means « why should we write this deviation? ». For this non-conformity, which is major/critical (a risk of recalled batches is widely recognized), it is necessary to raise a deviation in order to track the situation and solve it.

What is the advantage? The use of « 5W + 2H» allows to create a frame for the originator to describe a deviation in a structured way. Finally, the company has a clear view on the problematic and all the necessary information, in order to define:

• Immediate actions to put in place,
• If the production can continue or not (preliminary estimation of quality impact),
• The investigation to put in place,
• The root cause,
• Involved and concerned people,
• Corrective actions and preventive actions plan for solving the problem and avoiding reoccurrence,

The use of « 5W+2H » is not mandatory, nor apparent in the daily workload of a quality engineer. However, it could be interesting to know how to appropriate for yourself and use it in that case. Quality is a field which rhymes with rigor. Especially about the study of non-conformities. It is essential to have all the relevant information in order to work on a deviation, its correction and its prevention.