Interesting Article!

Partho Banerjee We are also working on similar lines for streamlining Technical Services in our Organization. Its an effective tool.

Beluh Mabasa Ginting Thank's . interesting article. Technical terms based upon the available data or evidence from FSCA need to be considered as well.

Antonin Cuc I am a State investigator for H+S in Medical Devices in the medical workflow, for example by implanting Orthopadic implants in Human Body. The fatal Mass repeated medical mistakes by users - in Orthopadic Clinic, there are facts, when the Orthopads, Radiologists, Forensic Doctors don´t respect Technician requirements of Laws for Users - because their mixed in medical workflow the Technical and Medical acts, without respects Technician legal conditions - for lack of Techical legal knowledges. In the Orthopady Clinics CZ are ignoring Binary Logics - when a likehod mixed partial activitiíes with evaluation True, False derived resulting FALSE - never the Loss of Mass Patients lives could be justified and validated coded as "Unhappy of Patients in usual habits in limits requirements LEGE ARTIS CZ". Yearly there are needless heavy crippled and preliminary dying about 40 thousands Patients CZ with fatal agreements Justice CZ, Criminal Police CZ, Knowing Court Medical Insitutes CZ!

This is a very common practice in the automotive field. Glad to see it is making its way to the medial.

Thanks for sharing!

I had trouble getting past the first paragraph. I would completely disagree that this is a good problem statement: "Customer X reports 2 shafts with part numbers 54635v4 found in customer’s assembly department with length 14.5 +/-2 mm measuring 14.12 mm and 14.11 mm.” Why: 1) Part numbers (plural)? Only one is specified. 2) Were they FOUND with length of 14.5 +/- 2 mm, or with lengths of 14.12 mm and 14.11 mm? (I assume 14.5 +/- 2mm is the acceptance specification, but it says they were "found...with length 14.5 +/- 2 mm") 3) Both 14.12 mm and 14.11 mm are within the (assumed) specification - so what is the problem??
This is actually a horrible problem statement. Accuracy, clarity, and grammar are important!

Thanks for sharing! Interested in knowing where the failure mode information is coming from in most cases. Are organizations reviewing their internally-received adverse event reports, or reviewing other sources as well?

Very good for RCA basics

Salvatore Domenic Morgera Another example of trying to resuscitate the cat after its been in the bag too, too long. Many medical devices fail (my experience is with medical devices whose focus is neurological dysfunction or neuropathies of different types) is, plain and simple, because the primary phenomena they pretend to address is not sufficiently well known and understood. The methods mentioned here and the many FEMA and ISO 14971 hours spent could be better spent up front in the research cycle. It is even difficult to get medical device manufacturers to understand that there are many POC's, and the most important one is that first, crude design concept that is closely integrated with a carefully thought out research cycle.

Yi Grace Lin Agreed that 'uneven skills' may have contributed to the inapt execution of a rigorous and adequate Root Cause Analysis (RCA) however I would also consider the demand on resource including time and people (with proper skills) could potentially impede its adoption. My experience has been that often only high risk issues would warrant an in-depth RCA.

Christine Zomorodian

Now that we have migrated to the new form space, are there any more questions or insights into the tool selection and basic practice of Root Cause Analysis (RCA)?

Nice article on RCA basics

Deryk Flood

4 steps how to carry out RCA: https://www.qmswrapper.com/blog/4-steps-how-to-carry-out-rca

Christine Zomorodian

Thank you, Deryk. Yet the link provided contains the same fault being discussed in my link: only suggesting one RCA tool for the analysis phase (5 Whys).

Christine Zomorodian

For everyone on this thread:
RCA is a required component of the medical device CAPA process and has been so for a long time. It is also recommended for investigating any systemic nonconformance, manufacturing excursion/out-of-bounds condition, or workplace accident.
The issue under discussion is the level of rigor applied to that investigation and what tools to apply in support of a thorough (therefore justifiable) analysis phase of investigation.
The reason is that Root Cause Determination is the basis of any Corrective Action(s) and the Preventive Action. Notified Bodies and (especially) FDA place a lot of emphasis on CAPA effectiveness. When they see a) repeated similar CAPAs, or b) CAPAs that can't close because the solutions are ineffective, they dig into your RCA process. This is one of the most typical inspection/audit findings and therefore, a popular audit focus.