Mark Proulx, CQA, cSSBB Shrikant Kalegaonkar Having worked with companies on this very issue, I can tell you that want you to do two things: 1) identify potential hazards, 2) determine the probability that these hazards could lead to harm. How you do this is up to you. If you prefer a PHA, be consistent in its use and make sure that you have SOPs that call out how to use them. I've seen some companies expand their dFMEAs and pFMEAs to include this information. We also used what the FDA calls an HHE (Health Hazards Evaluation). There is a copy of this form here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm217880.htm)

I've also performed some rather unique probability tables in HHE's that clearly state what the probability of hazard to harm MAY be (this is important to know that there is no such thing as 100% or 0% in any risk table.) So to answer your question, a PHA is one way you can record hazards, but you will still need an HHE-like doc, too.

Hi Shrikant. PHA can be used to identify hazards (clause 4.3), but not really to identify sequence of events that could result in a hazardous situation (clause 4.4).
For clause 4.3, I also recommend to collect data of similar device in events databases (Maude for US market) when existing.

Regards,
Carine

Shrikant Kalegaonkar PHA is a type of risk management tool. ISO 14971 does not explicitly require a PHA. ISO 14971 is an overarching standard that describes product risk management throughout the entire product lifecycle.

A PHA is a good tool. And you should include more than just a hazards analysis as part of your approach to ISO 14971 risk management.

I conducted a webinar on this topic recently. You can access the replay of this by going here: https://medicaldevicesgroup.net/webinar/iso-13485/.

I also can send you the Definitive Guide to ISO 14971 Risk Management. Just drop me a note.

Shrikant Kalegaonkar Thank you Mark Proulx, BSc, CQA, cSSBB, Carine Grelait , and Jon Speer for your helpful comments.

I thought PHAs include the following four elements: 1] hazards, 2] foreseeable sequence of events (FSEs), 3] hazardous situation and 4] harm. These are exactly the requirements of clause 4.3 and clause 4.4.

However, Carine, you're saying PHAs do not include FSEs. If so, I have not understood PHAs correctly. Do you have any recommendations for a good guide on PHAs?

Still, if PHAs cover items 1], 3], and 4], and ISO 14971 requires them plus item 2], I would be hard-pressed not to use PHAs.

In fact, my org replicates Table E.3 as part of its risk analysis process. I'm unsure whether Table E.3 is a PHA or not?

Mark, Carine, and Jon, don't FTAs & FMEAs just deal with fault/failure conditions? By themselves the wouldn't comply with the ISO 14971 requirement to identify hazards in normal or fault conditions, would they?

Jon, I've been studying your guide on Green Guru. Thank you for that!

Mark Proulx, CQA, cSSBB Shrikant Kalegaonkar Newer FMEAs are now taking into account the hazard and likelihood of harm (and think about it, how hard is it to add a couple more columns to a spreadsheet?) The HHE/HHA I spoke of earlier takes the hazard and walks the reader through the likelihood of harm. If an FMEA does not include the hazard or the possibility of harm, then it needs to have an HHE included (in the USA). PHA is not a formal or standardized thing. For that matter, I've seen many different kinds of FMEA templates, as well, even though the format is fairly well standardized. Just remember that whatever vehicle you choose to use, all elements of ISO 14971 that cover your product hazard leading to possible harm should be established. The format of the vehicle itself is less important than the content within. Best of luck and feel free to contact me if you'd like someone to look over your documentation and offer suggestions/comments.

It was my understanding that "Preliminary Hazard Analysis" is not a technique or procedure, like FTA and FMEA. Instead, it is <user picks an appropriate analysis> that is done before the design is complete in order to influence the early stages of the design. So it is more of a "when to do it" then a "how to do it." Because it occurs before the design is done, some techniques (FMEA) can't really be used. Do I understand it wrong?

PHA is an analysis method as described in 14971, G.2.
This method is actually the typical method for early risk analysis that enables the risk-based approach to the Design Control control process.
Often the probability of occurrence of the Harm is discussed. In reality, few people really know the likelihood of the damage: because who performs the clinical trials, just to get the probability of Harm? Do you have in your Clinical Evaluation reports the data that can be used to extract the likelihood for dying? PHA allows you to focus on the sequence of events to improve your product, independent from the real likelihood of probability of Harm.
Also the reporting system is not based on the real Harm occurrence, you also have to report the near incidents: it is the hazardous situation we want to get under control.
Therefore PHA is the tool to drive your system requirement specifications, before you switch to your techniques to drive your reliability analyses to prove your choosen design solutions to implement the system requirements specifications.