Examples of investigation or root-cause categories - Mother Nature (Environment)

v9991

Quite Involved in Discussions
#1
in 5M categories of Man-Machine-Method-Material, 5th M is Mother Nature,
what are the examples, relevant to manufacturing area. (typical examples for pharma and drug manufacturing is appreciated)
 
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Ajit Basrur

Staff member
Admin
#2
in 5M categories of Man-Machine-Method-Material, 5th M is Mother Nature,
what are the examples, relevant to manufacturing area. (typical examples for pharma and drug manufacturing is appreciated)
In the manufacturing world, "Mother Nature" happens to be the sixth M with the 5 "M" as -

Machine
Method
Material
Men or Man Power
Measurement

I got a very good explanation of the "Mother Nature" from http://ptgmedia.pearsoncmg.com/images/9780132300216/excerpts/0132300214_Excerpt.pdf where it is explained that -

Mother Nature (or a more encompassing term is environment), which includes external as well as workplace factors such as:

• Natural environment [weather (and acts of God), temperature, humidity]
• Physical surroundings (facilities, buildings, plant, workspace, office)
• Management surroundings (organizational, social, political)
• Marketplace

An example would be the recent incident at New England Compounding Center, the pharmacy that was in the news a few months back - http://www.nytimes.com/2012/10/22/health/meningitis-risk-haunts-14000-people.html

As part of the root cause investigation, a greenish-yellow residue was noticed on the sterilization equipment and the surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits. Addionally, the HVAC was switched off between 8 p.m. and 5:30 a.m. in the room where sterile drugs were manufactured and thereby proper temperature and humidity was not maintained and allowed the growth of microbes.

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v9991

Quite Involved in Discussions
#3
Mother Nature (or a more encompassing term is environment), which includes external as well as workplace factors such as:
? Natural environment [weather (and acts of God), temperature, humidity]
? Physical surroundings (facilities, buildings, plant, workspace, office)
? Management surroundings (organizational, social, political)
? Marketplace
.
i suppose that the T&RH supposed to be part of AHU-qualification? i.e., capacity.... (HVAC/AHU === machine?)
arn't physical surroundings to be covered part of plant design (facility qualification===method(process, systems)?)

arn't the 'management' is also covered under certain quality systems viz., management controls - policy etc.,

what are examples-significance of social-political-marketplace on quality systems/parma operations!!!.
 

Ajit Basrur

Staff member
Admin
#4
i suppose that the T&RH supposed to be part of AHU-qualification? i.e., capacity.... (HVAC/AHU === machine?)
arn't physical surroundings to be covered part of plant design (facility qualification===method(process, systems)?)

arn't the 'management' is also covered under certain quality systems viz., management controls - policy etc.,

what are examples-significance of social-political-marketplace on quality systems/parma operations!!!.
T&RH supposed to be part of AHU-qualification? i.e., capacity.... (HVAC/AHU === machine?)
Yes, you could cover under Machine and I have seen many RCA doing that way when they follow the typical 5M approach but to your question on a seperate "Mother Nature (or Environment), the HVAC related analysis like Particulates, Temp, Humidity etc comes under this section. The main point is to ensure its covered as part of your root cause analysis.

Additional examples would include the transporation of samples (not stored correctly). Again here, if follow 5M methodology, this would come under "Method" but when you have "Environment" as a Cause, all the related subcauses belong in this category.

arn't physical surroundings to be covered part of plant design
Same as earlier point ... either way you categorize is fine but comes under Environment when you have a seperate tab.

arn't the 'management' is also covered under certain quality systems viz., management controls - policy etc.,
In this section on Management surroundings, look beyond the quality systems. There could be some factors - for example, I know of an incident which happened way back when the union strikes were common in Pharma companies in India. In one organization during the union deliberations, there was a sabotage in which an employee introduced a foreign material in the tablets.

what are examples-significance of social-political-marketplace on quality systems/parma operations!!!.
In addition to some examples provided earlier, there could be - "Shipment delays" and this could be due to some excipients imported from Japan. During Tsunami, there were many suppliers whose factories were affected and hence the supply chain was disrupted.

Sometimes the supplier's factories could be gutted by fire or there could be some issues at suppliers that are external to your organization and beyond your control.
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