|
Server : Apache/2.4.62 System : FreeBSD fbsdweb2.web.rcn.net 14.1-RELEASE FreeBSD 14.1-RELEASE releng/14.1-n267679-10e31f0946d8 GENERIC amd64 User : www ( 80) PHP Version : 8.3.8 Disable Function : NONE Directory : /domains/srakitin/OLD/training/fda/ |
Upload File : |
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN">
<HTML>
<HEAD>
<TITLE>Root Cause Analysis for Medical Device Manufacturers</TITLE>
</HEAD>
<BODY>
<body bgcolor="#FFFFFF">
<!--- Logo and Page Title ---->
<p align="center">
<img src="../../gif/logo2008.gif" width=348 height=64 border=0 alt="logo2008">
</p>
<p align="center">
<font color=black size=5 face=Verdana>
<b>Training</b> </font>
</p>
<p align="center">
<img src="../../gif/topline.gif" width=915 height=6 border=0>
<br>
<p>
<center>
<table width=640>
<tr>
<td>
<font color="purple" size="3" face="Verdana">
<b><p align="center">Root Cause Analysis for Software-based Medical Devices </b></font>
</center><br></p>
</td>
</tr>
<tr>
<td>
<font size="2" face="Verdana">
<p> Of all the kinds of problems that medical device manufacturers face, complaints are clearly the
most important. This is because complaints can represent potential gaps in your knowledge of how
your customers use your devices. For software-based medical devices, complaints may be indicative
of deficiencies in your software development, validation, manufacturing, or setup processes.
Complaints can often result in disruptive, expensive, and unplanned software releases.
<p>
When complaints in software-based medical devices are not fully understood, they can result in poor
solutions that often create more problems than they solve. Nothing frustrates customers more than a
supplier who is unable to resolve problems quickly and correctly.
</td>
</tr>
</table>
</center>
<p>
<center>
<TABLE WIDTH=640>
<TR>
<TD colspan=2>
<font size="2" face="Verdana">
Root Cause Analysis has been routinely used to investigate the cause of major disasters including:
<p>
</TR>
<TR>
<TD width=70%>
<font size="2" face="Verdana">
<ul type=bullet>
<li>Airline crashes</li>
<li>Space Shuttle accidents </li>
<li>Chemical and nuclear plant disasters</li>
</ul>
An effective Root Cause Analysis process helps:
<ul type=bullet>
<li>understand causes of customer complaints</li>
<li>understand the what, the why, and the how� </li>
<li>reduce rework by preventing recurrence </li>
<li>identify process weaknesses </li>
<li>improve customer satisfaction </li>
</ul>
<p><p>
For software-based medical devices, the traditional Root Cause Analysis Process has been adapted to
accomodate development processes typically used to develop medical-device software.
</font>
</TD>
<TD width=30% ALIGN=LEFT>
<br>
<img src="../../gif/manufacturing.jpg" width=149 height=103 border=0>
<p>
</TD>
</TR>
</TABLE>
</center>
<p>
<center>
<TABLE WIDTH=640>
<TR>
<td>
<font size="2" face="Verdana">
<b>Root Cause Analysis Process Overview </b>
<p>
<font size="2" face="Verdana">
The Root Cause Analysis Process consists of investigating, understanding, and categorizing underlying
root causes of observed events. It is best performed by a small cross-functional team and is
easily incorporated into your Complaint Handling Process.
<p>
<font size="2" face="Verdana">
The Root Cause Analysis Process includes a detailed analysis based on gathering factual information
obtained from:
<ul type=bullet>
<li>Available documents and records </li>
<li>Interviews with staff and customers </li>
<li>Brainstorming sessions with staff </li>
</ul>
<p>
<font size="2" face="Verdana">
The Root Cause Analysis Process uses simple tools including:
<ul type=bullet>
<li>Why Trees </li>
<li>Pareto Analysis </li>
</ul>
<p>
<font size="2" face="Verdana">
An effective Root Cause Analysis Process helps determine appropriate and effective corrective actions
by identifying both an Immediate Corrective Action (what should be done today to resolve the complaint)
and Long Term Corrective Action (what should be done to prevent recurrence).
<p>
<font size="2" face="Verdana">
In applying this Root Cause Analysis Process, the Team starts with a specific complaint and asks:
<ul type=bullet>
<li>What is it about the way we operate that allowed this to occur?</li>
<li>What is it about the way this customer used our device that caused this to occur?</li>
</ul>
Most root causes are found in the way we operate. That includes:
<ul type=bullet>
<li>Who does what? </li>
<li>How things get done? </li>
<li>Why we behave way we do? </li>
</ul>
<p>
<font size="2" face="Verdana">
The Team asks questions about "Who does what", "How things get done", and "Why we behave the
way we do", in order to identify factual information that can be helpful in identifying real root
causes.
<p>
<font size="2" face="Verdana">
In asking these questions, the Team uses a tool called the Why Tree. Why Trees are similar to
Fault Trees in that the complaint is placed at the top. We then ask "Why did this happen?" and start
drilling down into "Who does what", "How things get done", and "Why we behave the way we do". At each
level, the Team continues to ask "Why" - usually at least five times (though for simpler problems, less
than five Whys may suffice).
<p>
<font size="2" face="Verdana">
The following illustrates a partially completed <b>Why Tree</b> for a simple problem:
<br><br>
</td>
</tr>
</table>
<center>
<img src="../../gif/WhyTree.jpg" width=640 height=445 border=0 alt="Why Tree">
</center>
<TABLE WIDTH=640>
<TR>
<td>
<p>
<font size="2" face="Verdana">
Answers to Why questions may need to be determined from documents (like Functional Specifications,
Test Plans, User Manuals, etc.), from records (like test results, manufacturing records, etc.), from
interviews with staff and customers, and from brainstorming sessions.
<p>
<font size="2" face="Verdana">
The information shown in green circles on the Why Tree example represents probable root causes. The
Team reaches consensus on the most probable root cause(s). Often, there will be more than one
root cause.
<p>
<font size="2" face="Verdana">
Using the Why Tree, the Team develops an Immediate Corrective Action (which could be a
workaround, hot fix, patch, new CDs, new doc, etc.). The team also identifies effectiveness checks
that can determine if the Immediate Corrective Action, once implemented, has effectively resolved the
complaint.
<p>
<font size="2" face="Verdana">
Once the Immediate Corrective Action is implemented and the effectiveness checks are satisfactory, the
Team decides if a Long Term Corrective Action is needed. A Long Term CA would be appropriate if
the root cause points to systemic problems. If so, they begin to develop a Long Term Corrective
Action. The Team does this by:
<p>
<font size="2" face="Verdana">
<ul type=bullet>
<li>Reviewing existing processes and procedures </li>
<li>Identifying process weaknesses directly related to root cause </li>
<li>Identifying potential process and procedure changes </li>
<li>Identifying long term effectiveness checks </li>
</ul>
<p>
<font size="2" face="Verdana">
Once the team has competed work on the Long Term Corrective Action, it can be presented to Management
and implemented. The team then collects data to determine if long term effectiveness checks are
satisfactory.
<p>
</td>
</tr>
</table>
<br>
<center>
<table width=600>
<tr>
<td>
<p><p>
<font size=3 face=Verdana Color=Red>
<b>Intended Audience</b></font>
<p>
<font size=2 face="Verdana" color=Black>
The intended audience for this workshop includes QA Staff, Complaint Handling Team, Software
Development, and Technical Support. Project Teams should attend this training together as a team,
if possible. Once a team has been trained, I frequently facilitate the first few meetings where the
Root Cause Analysis Process is applied.
</td>
</tr>
</table>
<br>
<table width=600>
<tr>
<td>
<font size=3 face="Verdana" color=Red>
<b>Tailoring</b>
<p>
</td>
</tr>
<tr>
<td width=20%>
<img src="../../gif/tailor.JPG" width=101 height=97 hspace=0 vspace=0 border=0
align="center" alt="tailor">
</td>
<td width=80%>
<font size=2 face=Verdana font color=black>
This workshop can be tailored to meet your specific needs and development process.
<p>Call for details...
</TD>
</tr>
</TABLE>
</center>
<!--- bottom line -->
<br>
<p align="center">
<img src="../../gif/bottomline.gif" width=915 height=6 border=0>
<br>
<!--- Contact Message -->
<center>
<br>
<p align="center">
<font size="3" color=Black face="Arial">
<b>For further information,
<p>call Steve Rakitin at <font size="3" color=Red face="Arial">508.529.4282</font>
<p><font size="3" color=Black face="Arial">or e-mail him at
<a href="mailto:[email protected]"><b>[email protected]</a></b><p><br>
<!--- Bottom Row of Links -->
<center>
<TABLE BORDER=0 WIDTH=375>
<TR>
<TD VALIGN="TOP" >
<FONT FACE="Verdana" color=black SIZE=1>
<a href="../index.html"><b>Home</b></FONT></a></p>
</TD>
<TD VALIGN="TOP" >
<FONT FACE="Verdana" color=black SIZE=1>
<A HREF="/company/summary.html">
<P ALIGN="CENTER"><b>Company Info</b></FONT></a>
</TD>
<TD VALIGN="TOP" >
<FONT FACE="Verdana" color=black SIZE=1>
<A HREF="/company/contact.html">
<P ALIGN="CENTER"><b>Contact Info</b></FONT></a>
</TD>
</TR>
</TABLE>
</center>
<br>
<!-- Copyright -->
<p align="center"><font size="1" color=black face="Arial">
Food for Thought and Predictable Software Development are trademarks of Software Quality Consulting, Inc.<br>
Copyright �2008 Software Quality Consulting, Inc. All rights reserved.<br>
<p>
Updated September 2008</font></p>
</body>
</html>