Preventing Packaging Failures Using FMEA

In Part 1, I introduced the FMEA methodology as a tool to prevent failures or defects in packages and reduce the risk of losing a customer or negatively impacting patients. It can be especially useful when “evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process” (source: Institute for Healthcare improvement University of Chicago).

Paolo Scalisi

The FMEA method is based on a document that has to be regularly reviewed with experience and production data history in mind. The goal is to define precisely the boundaries of the analysis by focusing on the operating conditions of the medical packaging production process under examination.

This step works best if accomplished by multicultural team, which has to follow exactly the FMEA procedure. Each member of the FMEA team has to bring into the team his creativity and experience, moreover any expert from suppliers and customers, who can help to fill correctly the FMEA documentation.

There is a preliminary work that the team has to do before to elaborate a FMEA document, that is essentially to gather and analyze some documents, such as the:

  • Bill of material (BOM)
  • Package construction analysis
  • Specific applicable medical standards
  • Legal and regulatory requirements
  • Quality agreements
  • Validation plans

After this first step, the steps to be followed are (source Quality-One):

  • Path 1 Development (Failure Modes)
  • Path 2 Development (Causes & Occurrences)
  • Path 3 Development (Testing & DV Development)
  • Action Priority & Assignment
  • Actions Taken / Design Review
  • Re-ranking RPN & Closure

The Path 1, 2, 3 are parts of the functional analysis that is a method to characterize the functions of the production process of the medical packages to satisfy the customer requirements (see fig.1).

Figure 1


To individuate the potential failure modes it’s necessary to isolate some potential failure modes, and a related list of the potential consequences of each failure mode on people (patients) or infrastructures in danger, on quality decrease of the manufactured medical packages and on the final customer. The main question is: Why is there this failure? For this reason the potential causes should be described as events which can be corrected and controlled.

This can be done by mean of the cause-effect (Fishbone) diagram that is a scheme of identified causes of a potential failure mode that could affect the medical packages production system (see fig. 2).

Figure 2


Once the causes have been individuated the corrective actions (Action Priority & Assignment, Actions Taken / Design Review, Re-ranking RPN & Closure) will be determined as well.

The corrective actions priority to realize a good quality medical packaging production process is given by the Criticality Matrix (see fig.3).

Figure 3


Resolving or preventing a quality issue of the production process of medical packages production. Do you know alternative methods to find the potential root causes of a low quality medical packages production process? Did you ever participate to a FMEA team?

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Paolo Scalisi, STMicroelectronics Italy

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