Equipment URS, pFMEA and dFMEA

#1
Hi everybody,
I work as manufacturing engineer and i have a project to build an automated equipment for assemble one of the products. I’m not sure about the stages that i should follow related to risk management (we use pFMEA for risk analysis).
We have dFMEA for every product.
What should go first: writing the pFMEA and then i should write the equipment user requirements? or maybe the opposite way?
How i make the link between the dFMEA and pFMEA?
 
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Tidge

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#2
I am assuming a top-level Hazard Analysis with subordinate documents which include FMEA.

1) You need to establish (a) if there are any elements of the design which require specific manufacturing processes to either control risks (such as sterilization) or (b) to guarantee that the device's requirements are satisfied (such as calibration). These should be identified in the design FMEA, or at least the risks will be obvious in the Hazard Analysis. Such necessary manufacturing process steps will be invite remarks like "The device won't be safe/won't work unless this is done in manufacturing."

2) You should look at the manufacturing processes to understand if (a) what the impact to the risk profile of the device could be if the process results in "out of specification" (sub)components and finished goods, and (b) what (if any) manufacturing process steps could damage a (sub)component or finished good. The vernacular around these types of manufacturing process steps will be something like "please just make the device as designed, and don't break it during manufacturing."

The elements of (2a) are essentially understood via process validation and monitored via control charts. The elements of (2b) require slightly more critical thinking and analysis. For example, many manufacturers implement a "burn-in" process for certain devices to reveal "bathtub curves"... but the curve itself should be understood for the device to understand that such a test isn't unreasonably shortening the expected life of the product.

For all of the above, you will have lines of analysis in a PFMEA, but they will likely trace directly to the HA, although some cross-referencing for the DFMEA for the points in (1) can be expected.
 

Tidge

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#4
I will provide some (possibly, seemingly random) thoughts on this question:
Does machine URS should be written before or after process risk analysis?
Manufacturing process requirements should be derived from device design requirements. The risk analysis process for medical devices begins earlier than the establishment of manufacturing methods. Risk analysis will occur parallel with other Design History File activities, but typically elements of an established design will dictate the necessary production activities.

A key element of risk analysis is the iterative nature of risk analysis; this is how particular choices in manufacturing can appropriately find themselves referenced in a risk analysis (as potential contributors to risk) even if those choices were not established as risk controls as design elements for the device.

Minor digression follows:

A 14971-compliant risk analysis is only concerned with patient/user risk (modulo some vague extra wording about "environment" and "other stakeholders") but risk controls for other risks (e.g. business risk due to scrap, the safety of manufacturing equipment operators). Fussy disciples of 14971 may insist that you leave references to such controls out of a process FMEA. My opinion is that such controls ought to be included in PFMEA, since:
  • a majority of medical device manufacturers won't have any other document preserving information about the origin/purpose of such controls, and
  • when a manufacturing process change is proposed (for any reason, including "non-DMR" reasons) the pFMEA for the process is likely to be one of the few documents that is examined
It is typically not appropriate to claim any reduction of risk (in the 14971 context) for such risk controls. However, there has been a significant increase in the expectation by third parties to find"line-by-line" (or "individual") analyses for each risk control anyway, so it makes complete sense to me that a manufacturer could included (in a pFMEA supporting a 14971-inspired analysis) and simply make it clear that these controls are not implemented to reduce risks to patients/user.
 
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