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	<title>The Arena Blog &#187; Document Control</title>
	<atom:link href="http://blog.arenasolutions.com/category/document-control/feed/" rel="self" type="application/rss+xml" />
	<link>http://blog.arenasolutions.com</link>
	<description>On product design, development &#38; manufacturing</description>
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		<title>Are engineering change requests a necessary part of your process?</title>
		<link>http://blog.arenasolutions.com/engineering-change-requests-process/</link>
		<comments>http://blog.arenasolutions.com/engineering-change-requests-process/#comments</comments>
		<pubDate>Mon, 16 Jan 2012 14:04:25 +0000</pubDate>
		<dc:creator>Alex Gammelgard</dc:creator>
				<category><![CDATA[Arena]]></category>
		<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Engineering Change Management]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=5809</guid>
		<description><![CDATA[Although a solid change management process is absolutely necessary, it’s easy to fall into an overly complicated, unnecessary or misunderstood engineering change request (ECR) process—especially if your process lacks purpose. In some cases, by the time you craft the ECR, add in the appropriate documentation, talk it over with the product engineer and send the [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://blog.arenasolutions.com/engineering-change-requests-process/whats-the-point/" rel="attachment wp-att-5810"><img class="alignright size-medium wp-image-5810" title="What's the point" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2012/01/Whats-the-point-207x300.gif&amp;aoe=1&amp;q=100&amp;w=207&amp;h=300&amp;hash=6910b459ee7ebe8447bfb47e177dcd78" alt="" /></a>Although a solid <a href="http://www.arenasolutions.com/product/features/engineering-change-management.html">change management process</a> is absolutely necessary, it’s easy to fall into an overly complicated, unnecessary or misunderstood engineering change request (ECR) process—especially if your process lacks purpose.</p>
<p>In some cases, by the time you craft the ECR, add in the appropriate documentation, talk it over with the product engineer and send the ECR around for approval, the engineering change order (ECO) is completely redundant.</p>
<p>So if your ECRs are just being used as mini ECOs, do you really need them? If the same people go through the same process twice for every change, and there are no real differences between ECRs and ECOs, what’s the point of having both?</p>
<h2><strong>Give your engineering change requests a purpose</strong></h2>
<p>While there are some exceptions, ECRs are actually an important part of the change process for most companies. However, it’s important that you know why you are writing ECRs in the first place, and that you enable the right people to participate in the ECR process.</p>
<p>In many companies, an engineer will write an ECR, send it to key players for approval and then write an ECO to put through the same process with some additional people included, like the VP of engineering.  In this example, the ECR is a fairly unimportant part of the overall change process—especially if most people ignore the ECR on the first round, knowing there is an ECO coming.</p>
<p>In many ways, having engineers come up with ECRs is somewhat contrived. When an engineer submits an ECR, it’s not usually to request a change; it’s to propose a solution. To make the most of the ECR process, and separate it from the ECO process, consider incorporating customer, supplier and manufacturing feedback into your ECR process.</p>
<h2><strong>How can you make the most of ECRs?</strong></h2>
<p>Some companies use ECRs as a way to document proposed, accepted and rejected engineering changes, particularly in highly regulated environments. If you’re using Arena, ECRs are a great way to informally discuss an issue—and capture the discussion—before you create a formal change.</p>
<p><strong></strong>In smart organizations, engineering change requests are a formalized way people outside engineering can make recommendations for change. Within our customer base, we see this in a variety of ways.</p>
<p>Some organizations use ECRs as a way to capture customer complaints. One really innovative way to do this is to link your customer case system to the request system in your PLM tool.</p>
<p>Other companies use ECRs to increase/improve communication with suppliers. You may not want to loop your supplier into your ECO process, but when you think about it, your supplier is in a perfect position to catch problems with the parts you’re purchasing, or notice places you can optimize across product lines. Encouraging suppliers to submit ECRs gets them involved, but is less of a commitment than an ECO.</p>
<p>In general, ECRs are a great way to capture suggestions without incorporating everyone into your ECO process. ECRs can capture defects at all levels—supplier defects, shop floor defects, customer concerns, feedback from sales. A natural flow might look like this: a product issue comes in from customer support, an incident report is created in your customer care system and the ECR to ECO process begins.</p>
<p>If you are leveraging change requests properly, you will stop thinking of them as busy work, and start thinking of them as a way to incorporate more relevant feedback into your process.</p>
<h2><strong>For more information: </strong></h2>
<p><a href="http://www.arenasolutions.com/engineering-change-request.html">What’s an engineering change request form?</a></p>
<p><a href="http://blog.arenasolutions.com/change-process-2012/">Is your change process in check for 2012?</a></p>
<p><a href="http://blog.arenasolutions.com/common-change-management-problems/   ">Three common change management problems and how to solve them</a></p>
<p><a href="http://www.arenasolutions.com/resources/whitepapers/dl/effective-change-management.html">Three essential tips for effective change management</a></p>
<p><a href="http://www.arenasolutions.com/product/features/engineering-change-management.html">Engineering change management in Arena</a></p>
]]></content:encoded>
			<wfw:commentRss>http://blog.arenasolutions.com/engineering-change-requests-process/feed/</wfw:commentRss>
		<slash:comments>4</slash:comments>
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		<item>
		<title>Three considerations when choosing the part numbering scheme that’s right for you</title>
		<link>http://blog.arenasolutions.com/three-considerations-part-numbering-scheme-that%e2%80%99s-right-for-you/</link>
		<comments>http://blog.arenasolutions.com/three-considerations-part-numbering-scheme-that%e2%80%99s-right-for-you/#comments</comments>
		<pubDate>Wed, 11 Jan 2012 14:05:44 +0000</pubDate>
		<dc:creator>Alyssa Sittig</dc:creator>
				<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Engineering]]></category>
		<category><![CDATA[Operations]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=5868</guid>
		<description><![CDATA[Choosing a part numbering scheme is one of the more important decisions you make as you move toward production. Once you commit to a part numbering scheme, you are married to it for a long time to come, so you need to be 100% sure it is nimble enough to evolve and scale right along [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://blog.arenasolutions.com/three-considerations-part-numbering-scheme-that%e2%80%99s-right-for-you/stopsign/" rel="attachment wp-att-5869"><img class="size-full wp-image-5869 alignright" title="stopsign" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2012/01/stopsign.jpg&amp;aoe=1&amp;q=100&amp;w=425&amp;h=282&amp;hash=b91432477ee9ca17033e4a6147deb645" alt="" /></a>Choosing a part numbering scheme is one of the more important decisions you make as you move toward production.</p>
<p>Once you commit to a part numbering scheme, you are married to it for a long time to come, so you need to be 100% sure it is nimble enough to evolve and scale right along with you.</p>
<p>I’ve written some articles recently addressing the <a href="../../../../../part-numbering-winning-debate/">pros and cons of intelligent and non-intelligent part numbering</a>, as well as <a href="../../../../../intelligent-number-rabbit-hole/">unique challenges</a> that come with an intelligent part numbering system that are useful to read as you decide on a part numbering system. But even within the buckets of intelligent and non-intelligent, part numbering schemes vary. Ultimately, the correct system is one that takes your unique business process into consideration.</p>
<p>So before you commit to any part numbering scheme, ask yourself these three questions:</p>
<h2>#1: How do part numbers serve each team within your organization?</h2>
<p>In your search for the ideal part numbering scheme, consider how the entire enterprise will be affected.</p>
<p>In general, engineering and design teams tend to prefer intelligent part numbering schemes because the descriptive names can help them identify parts more quickly. On the other hand, your operations department may prefer the efficiency and universality of non-intelligent numbering schemes.</p>
<p>Your engineering team may want some intelligence built into the part numbering system so they can quickly identify components. For example, they may often need to zero in on capacitors or resistors within the BOM, and want a special label to identify those items.</p>
<p>There may also be automated processes connecting business system that rely heavily on the formatting of part numbers—for example the number of characters in the part numbering string. If this is the case, your part numbering format must be perfectly consistent and uniform in order to make sure integrations don&#8217;t break down.</p>
<h2>#2: Will your part numbering scheme incorporate suppliers, contract manufacturers or different business systems?</h2>
<p>Considering the needs of manufacturing partners outside your immediate organization is also a smart idea (although this can be difficult if you are still establishing key partners in your production process.) Your suppliers have a stake in your numbering scheme too, so finding out how they manage part numbers can help you optimize your process from the beginning.</p>
<p>It may also make sense to consider your organization’s position in the manufacturing chain and how many organizations you will be working with up and down the chain. If you are sending data to several organizations on both ends, you may want to choose a system that is as standardized as possible.</p>
<h2>#3: What business tools will you use to manage your parts?</h2>
<p>Adopting a new part numbering scheme is a major move—you don’t want to complicate matters by choosing a scheme that is too complicated for your existing business tools.</p>
<p>For example, if you manage part numbers in Excel, you may need to include information in the part that helps you run part searches. If you use a PLM system that can generate automated numbers for you, you need to decide how to communicate this information with vendors working outside your PLM system.</p>
<h2>Lightweight automated tools to help you number</h2>
<p>Many PLM and ERP systems simplify the process of generating and tracking part numbers. But if you’re a small manufacturer who doesn’t have access to one of these tools, or is still <a href="../../../../../10-steps-excel-boms/">stuck in Excel</a>, here are some web services that can help you generate part numbers relatively easily.</p>
<p>- <a href="http://www.part-numbering.com/">Part-numbering.com</a>: This free service allows you to use generate part numbers in the formats that best fits your needs, whether you want to create multiple intelligent numbering schemes or a single non-intelligent scheme.</p>
<p>- <a href="http://partnumber.com/">Partnumber.com</a>: This is a free application for assigning intelligent part numbers and creating part descriptions.</p>
<p>Both these services are straightforward and can help you get started with numbering. But as your system becomes more complicated, tools that can help manage a large library of part numbers is recommended.</p>
<p><em>Putting any kind of new system in place is a challenge. Do you have any war stories you’d like to share?</em></p>
<p><strong>For more information:</strong></p>
<p><a href="../../../../../part-numbering-winning-debate/">Intelligent vs. non-intelligent part numbering—who’s winning the debate?</a></p>
<p><a href="../../../../../intelligent-number-rabbit-hole/">A trip down the intelligent part numbering rabbit hole</a></p>
<p><a href="http://www.arenasolutions.com/part-number-system.html">Part numbering system: How to get started</a></p>
<p><a href="../../../../../10-steps-excel-boms/">10 simple steps to free your BOMs from Excel</a></p>
]]></content:encoded>
			<wfw:commentRss>http://blog.arenasolutions.com/three-considerations-part-numbering-scheme-that%e2%80%99s-right-for-you/feed/</wfw:commentRss>
		<slash:comments>3</slash:comments>
		</item>
		<item>
		<title>A trip down the intelligent part numbering rabbit hole</title>
		<link>http://blog.arenasolutions.com/intelligent-number-rabbit-hole/</link>
		<comments>http://blog.arenasolutions.com/intelligent-number-rabbit-hole/#comments</comments>
		<pubDate>Wed, 04 Jan 2012 14:00:58 +0000</pubDate>
		<dc:creator>Alyssa Sittig</dc:creator>
				<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Engineering]]></category>
		<category><![CDATA[Operations]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=5696</guid>
		<description><![CDATA[Now that I’ve given you a high level analysis of the pros and cons of intelligent and non-intelligent part numbering, I can tell you how I really feel. While well intentioned, intelligent numbering schemes can be a tricky rabbit hole—hostile to growth for a variety of reasons. A good part numbering scheme is nimble. It [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://blog.arenasolutions.com/intelligent-number-rabbit-hole/rabbithole/" rel="attachment wp-att-5728"><img class="alignright size-full wp-image-5728" title="rabbit hole" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2012/01/rabbithole.jpg&amp;aoe=1&amp;q=100&amp;w=363&amp;h=240&amp;hash=acd11d12abed998c855ad027be642fb4" alt="" /></a>Now that I’ve given you <a href="../../../../../part-numbering-winning-debate/">a high level analysis</a> of the pros and cons of intelligent and non-intelligent part numbering<em>, </em>I can tell you how I really feel. While well intentioned, intelligent numbering schemes can be a tricky rabbit hole—hostile to growth for a variety of reasons.</p>
<p>A good part numbering scheme is nimble. It generates part numbers efficiently and can be maintained without too much brainwork. In other words, it’s the opposite of intelligent part numbering.</p>
<p>Because intelligent schemes are descriptive in nature, it takes more effort to add new parts into the system, and to maintain the system as you grow. To generate a new part number, you’ll need to understand the part, including any specific features or functionalities that go into the name, before determining where it fits into your intelligent scheme. Intelligent part numbering schemes are inherently harder to modify than non-intelligent ones, since all new parts need to be understood and defined within the context of other parts.</p>
<h2>What happens if I fall down the intelligent part numbering rabbit hole?</h2>
<p><strong>1. You’ll drain resources. </strong></p>
<p>Intelligent part numbers are easily susceptible to descriptive clutter—becoming very confusing, hard to read and impossible to remember. Truncating descriptive terms into abbreviations becomes difficult to keep straight and requires continual employee training and monitoring.</p>
<p>Imagine, for instance, trying to recall whether a part number was intended to specify length then gauge, or the opposite. Does ‘R-12-06’ mean the part is a 12-gauge or that it is half an inch? Small misinterpretations like this one can have unpredictable, and disastrous, consequences.<strong><br />
</strong></p>
<p><strong>2. Small design modifications can cause confusion.</strong></p>
<p>When the time comes to modify an intelligently named part—whether it’s adding in a new description to the part number that wasn’t necessary before, or modifying the specs of a part—the change can invalidate or conflict with the part numbers that already exist.</p>
<p>It’s hard to know just how descriptive to get when creating intelligent numbers—and almost no one gets it completely right the first time around. Let’s say you have a 4 gauge, 8 inch green cable. You number the cable ‘G-8-4’ accordingly and use the same scheme for the 200 other cables in your product. Fast forward a few weeks and you discover you can now buy the same cable, but with shielding.</p>
<p>Integrating the new cable into your product will make it better, but will force you to update your cable numbering scheme to indicate ‘shielded’ or ‘unshielded.’ You’re in a lose-lose situation—forced to choose between foregoing a smart part upgrade because you’re locked into your numbering scheme, or wasting time updating old numbers.</p>
<p>Each time you need to add a new parameter to your numbering scheme, you will have to go back and update the numbers for all affiliated parts, dramatically decreasing the sustainability of your system.</p>
<p><strong>3. You’ll be stuck with an outdated system. </strong></p>
<p>Like everything else, manufacturing is going digital—just look at the increased use of <a href="../../../../../qr-codes-manufacturing/">QR codes on the factory floor</a>.  This development will soon make descriptive part numbers completely unnecessary.</p>
<p>Now that computers can track part descriptions for us, we do not need part numbers to do the heavy lifting for us.  Computers allow manufacturers to track part numbers with descriptions, so there is no need for the part number to convey intelligent information on its own. Rick Lansky from <a href="http://www.part-numbering.com/blog/7/Why-you-should-NOT-be-using-an-intelligent-part-numbering-system">part-numbering.com</a> sums it up best when he said, “intelligent part numbers are an historical artifact.”</p>
<p><strong>What do you think? </strong>Have you found value in intelligent numbering schemes?</p>
<p><strong>For more information:</strong></p>
<p><a href="http://blog.arenasolutions.com/part-numbering-winning-debate/">Intelligent vs. non-intelligent part numbers—who&#8217;s winning the debate?</a></p>
<p><a href="http://blog.arenasolutions.com/significant-part-numbering-tips/">Significant part numbering tips</a></p>
<p><a href="http://www.arenasolutions.com/part-number-system.html">Part numbering system: How to get started</a></p>
<p><a href="http://blog.arenasolutions.com/10-steps-excel-boms/">10 simple steps to free your BOMs from Excel</a></p>
<p>&nbsp;</p>
]]></content:encoded>
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		<slash:comments>6</slash:comments>
		</item>
		<item>
		<title>Intelligent vs. non-intelligent part numbering &#8211; who&#8217;s winning the debate?</title>
		<link>http://blog.arenasolutions.com/part-numbering-winning-debate/</link>
		<comments>http://blog.arenasolutions.com/part-numbering-winning-debate/#comments</comments>
		<pubDate>Thu, 22 Dec 2011 14:00:14 +0000</pubDate>
		<dc:creator>Alyssa Sittig</dc:creator>
				<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Engineering]]></category>
		<category><![CDATA[Operations]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=5530</guid>
		<description><![CDATA[Your part numbering scheme is ultimately adopted by every team with a stake in product development—from design and engineering to operations and manufacturing—so it’s no surprise that choosing the right scheme is a point of debate for many companies. Most manufacturing circles today still hold on to the belief that intelligent part numbering schemes are [...]]]></description>
			<content:encoded><![CDATA[<h2><a href="http://blog.arenasolutions.com/part-numbering-winning-debate/colorful-numbers/" rel="attachment wp-att-5535"><img class="alignright size-full wp-image-5535" title="Colorful numbers" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/12/colorful-numbers.jpg&amp;aoe=1&amp;q=100&amp;w=283&amp;h=212&amp;hash=1061b9e27e0dfd8cb199771cc69aef55" alt="" /></a></h2>
<p>Your part numbering scheme is ultimately adopted by every team with a stake in product development—from design and engineering to operations and manufacturing—so it’s no surprise that choosing the right scheme is a point of debate for many companies.</p>
<p>Most manufacturing circles today still hold on to the belief that intelligent part numbering schemes are better at managing parts than non-intelligent schemes—but this is starting to change. More manufacturers today are finding the effort to maintain descriptive-dependent part numbers not worth the assumed benefit, and are instead turning to automated tools to generate serial part numbers.</p>
<p>While we offer <a href="http://www.arenasolutions.com/part-numbering.html">several helpful resources</a> on our website to explain the differences between intelligent and non-intelligent numbering schemes, this blog series is designed to help you identify the part numbering scheme that is right for your unique business needs.</p>
<h2>The pros and cons of intelligent part numbering</h2>
<p>Intelligent part numbering schemes, which use descriptive details about the part to communicate part characteristics, are designed to help manufacturers save time and avoid confusion. However, assigning a descriptive meaning to each part number may lock you into a system that can’t scale as your variety and quantity of parts increases.</p>
<p>Considering the needs of your business will help you identify whether a descriptive or serial system is right for you.</p>
<table class="new" width="700" cellspacing="0" cellpadding="0">
<tbody>
<tr>
<th width="33%">Advantages</th>
<th style="border-left: none;">Why it works</th>
</tr>
<tr>
<td style="border-top: none;"><strong>Efficient searching</strong></td>
<td style="border-left: none; border-top: none;">If you’ve labeled all resistors with part numbers starting with ‘RES’ (for example), you can more easily group similar parts in your design documentation together and swiftly sort among them.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>Clear frame of reference for each part</strong></td>
<td style="border-left: none; border-top: none;">Descriptive part numbers specify the group to which every part belongs, so you can immediately see when a part is in the wrong group.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>Process efficiency</strong></td>
<td style="border-left: none; border-top: none;">Because parts with similar naming conventions are all handled the same way, you can predefine the change routings, review processes and manufacturing steps for each part number class or category.</td>
</tr>
</tbody>
</table>
<table class="new" width="700" cellspacing="0" cellpadding="0">
<tbody>
<tr>
<th width="33%">Disadvantages</th>
<th style="border-left: none;">Why it’s a challenge</th>
</tr>
<tr>
<td style="border-top: none;"><strong>Training and knowledge required</strong></td>
<td style="border-left: none; border-top: none;">The individual responsible for assigning part numbers must understand which group to place the part in and how subgroups interact. Because so much is based on the naming convention, mis-naming a part can jeopardize the product design.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>Ongoing maintenance</strong></td>
<td style="border-left: none; border-top: none;">Descriptive part numbers require foresight and continual adjustment as you incorporate new parts into your design. Part group sizes must also be considered in advance so you don’t get stuck with a significant number string 0-9 and an eleventh part.</td>
</tr>
</tbody>
</table>
<h2>The pros and cons of non-intelligent numbering schemes</h2>
<p>If you don’t think the pros of intelligent part scheming outweigh the cons, your other option is to adopt a non-intelligent scheme. In a non-intelligent part numbering scheme, numbers are chosen systematically (typically serially) and do not provide any information about the part. These systems can be easy to maintain and are easier in some ways because they require less training to learn. Plus, the responsibilities of managing this kind of system can be more easily shared in the organization.</p>
<p>But non-intelligent schemes are far from error-proof. Mistakes can go unnoticed—especially if data entry is involved, and it can be more difficult to manage similar parts.</p>
<table class="new" width="700" cellspacing="0" cellpadding="0">
<tbody>
<tr>
<th width="33%">Advantages</th>
<th style="border-left: none;">Why it works</th>
</tr>
<tr>
<td style="border-top: none;"><strong>Time savings</strong></td>
<td style="border-left: none; border-top: none;">It takes very little time and thought to generate a part name because you do not need to know anything about the part to assign a number.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>Little training needed</strong></td>
<td style="border-left: none; border-top: none;">New hires do not need training on naming methods and can focus their attention on other tasks.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>No single point of failure</strong></td>
<td style="border-left: none; border-top: none;">You can easily have multiple people pull part numbers, which increases efficiency by reducing dependencies.</td>
</tr>
</tbody>
</table>
<table class="new" width="700" cellspacing="0" cellpadding="0">
<tbody>
<tr>
<th width="33%">Disadvantages</th>
<th style="border-left: none;">Why it’s a challenge</th>
</tr>
<tr>
<td style="border-top: none;"><strong>Requires a business system to search parts</strong></td>
<td style="border-left: none; border-top: none;">In order to navigate through spreadsheets with randomized part numbers, you need a system that can search for parts based on description, name, size or other relevant attribute .</td>
</tr>
<tr>
<td style="border-top: none;"><strong>Potential for errors</strong></td>
<td style="border-left: none; border-top: none;">Numbers do not contain cues to help someone evaluate a part, and do not provide a frame of reference to determine whether the part makes sense in the context of other data.</td>
</tr>
<tr>
<td style="border-top: none;"><strong>More work to manage parts</strong></td>
<td style="border-left: none; border-top: none;">Within common prefixes, you’ll need to track additional metadata to define your parts and use that information to search for parts.</td>
</tr>
</tbody>
</table>
<h2>Keeping the big picture in mind</h2>
<p>If your company has a wide variety of complex parts, multiple product lines or global supply partners, than implementing an intelligent part numbering scheme may be too difficult to maintain. But if assigning descriptive part numbers won’t put a bottleneck in your process and will benefit your teams, than it may be worth the extra effort.</p>
<p>Think about it this way: Can your company afford the time and training necessary to modify an intelligent numbering scheme as you scale? Or is a more appropriate question whether you can afford to have no frame of reference as you look at a list of part numbers?</p>
<p>Considering your unique manufacturing processes, business trajectory and product will help you identify which questions to ask in order to get the answers you need.</p>
<p>To get your gears turning for my next blog post in our series on part numbering, ask yourself—is intelligent part numbering really all that intelligent?</p>
<p>Stay tuned.</p>
<p><strong>For more information</strong>:</p>
<p><a href="http://blog.arenasolutions.com/intelligent-number-rabbit-hole/">A trip down the intelligent part numbering rabbit hole</a></p>
<p><a href="http://blog.arenasolutions.com/three-considerations-part-numbering-scheme-that%E2%80%99s-right-for-you/">Three considerations when choosing the part numbering scheme that&#8217;s right for you</a></p>
<p><a href="http://blog.arenasolutions.com/significant-part-numbering-tips/">Significant part numbering tips</a></p>
<p><a href="http://www.arenasolutions.com/part-number-system.html">Part numbering systems: How to get started</a></p>
<p><a href="http://blog.arenasolutions.com/10-steps-excel-boms/">10 simple steps to free your BOMs from Excel</a></p>
]]></content:encoded>
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		<title>Is your product record lost in translation?</title>
		<link>http://blog.arenasolutions.com/ambiguous-product-record/</link>
		<comments>http://blog.arenasolutions.com/ambiguous-product-record/#comments</comments>
		<pubDate>Thu, 27 Oct 2011 14:37:16 +0000</pubDate>
		<dc:creator>Alex Gammelgard</dc:creator>
				<category><![CDATA[BOM Management]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Outsourced Manufacturing]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=4542</guid>
		<description><![CDATA[When you outsource assembly, the product of your engineering department isn’t really hardware—it’s raw information. This raw information (BOMs, drawings, specifications, purchasing and sourcing information) is of critical importance to your suppliers, yet many OEMs lack visibility into how ambiguous their data can be when it&#8217;s received on the other end. The idea of throwing [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://blog.arenasolutions.com/ambiguous-product-record/istockconfuse-sign/" rel="attachment wp-att-4543"><img class="alignright size-full wp-image-4543" title="confusion" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/10/istockconfuse-sign.jpg&amp;aoe=1&amp;q=100&amp;w=375&amp;h=248&amp;hash=f934e84ee68516b95c6d9eaac381963b" alt="" /></a>When you outsource assembly, the product of your engineering department isn’t really hardware—it’s raw information.</p>
<p>This raw information (BOMs, drawings, specifications, purchasing and sourcing information) is of critical importance to your suppliers, yet many OEMs lack visibility into how ambiguous their data can be when it&#8217;s received on the other end.</p>
<p>The idea of throwing product data over the wall is a major source of frustration for OEMs. While it can be a struggle to get the right information to the right person at the right time, its important that the people building your product receive the information they need.</p>
<h2>Your CM: An ally in the fight against product record ambiguity</h2>
<p>Fortunately, your contract manufacturer wants to minimize ambiguity too.</p>
<p>It shouldn’t come as a surprise that your CM partners dislike fighting over quality problems, excess and obsolete inventory, or the costs of a product recall or field service problem. And if the source of confusion is often due to incomplete, messy or outdated product data, this is something you can easily fix.</p>
<p>If you think you may be sharing less-than-perfect data with your suppliers, here is a list of four things you can do to ensure you are giving your supplier team the information they need to be successful.</p>
<h2><strong>Four things you must do to eliminate product record confusion!</strong></h2>
<p><strong>1. Define:</strong></p>
<ul>
<ul>
<li>what makes each part/revision acceptable</li>
<li>which parts should be used (and when)</li>
<li>assembly instructions for how parts go together physically</li>
</ul>
</ul>
<p><strong>2. Control:</strong></p>
<ul>
<ul>
<li>who can edit your BOMs (and how)</li>
<li>how related BOM updates are grouped</li>
<li>who reviews &amp; approves BOM changes</li>
<li>how &amp; when BOM changes become effective</li>
</ul>
</ul>
<p><strong>3. Communicate:</strong></p>
<ul>
<ul>
<li>sufficient information to build the product</li>
<li>only the necessary information</li>
<li>each and every update to the BOM</li>
</ul>
</ul>
<p><strong>4. Collaborate: </strong></p>
<ul>
<ul>
<li>sign-off for BOM changes (in advance)</li>
<li>requests for improvements</li>
<li>up-to-date status</li>
</ul>
</ul>
<p><strong>And a bonus tip (that a lot of companies struggle with):</strong> Keep a historical BOM accurate and unambiguous. To do this, it’s helpful to adopt a system that allows you to manage change over time (<a href="http://www.arenasolutions.com/">like Arena</a>.)</p>
<h2>Helping your suppliers is a win—win situation</h2>
<p>Ambiguity can sometimes seem like an unavoidable part of the outsourcing relationship—especially when it comes to sharing your product record. But with the right processes in place, you can communicate with your CM partners with focus and purpose.</p>
<h2>For more information:</h2>
<p><a href="http://www.arenasolutions.com/manufacturing-outsourcing.html">Tips and resources for managing your outsourcing relationships </a></p>
<p><a href="http://www.arenasolutions.com/resources/whitepapers/dl/revision-control.html">Three tips for effective product revision control and communication </a></p>
]]></content:encoded>
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		<item>
		<title>Do QR codes belong on the shop floor?</title>
		<link>http://blog.arenasolutions.com/qr-codes-manufacturing/</link>
		<comments>http://blog.arenasolutions.com/qr-codes-manufacturing/#comments</comments>
		<pubDate>Tue, 20 Sep 2011 14:00:02 +0000</pubDate>
		<dc:creator>Eric Larkin</dc:creator>
				<category><![CDATA[Arena]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Innovation]]></category>
		<category><![CDATA[Product Management]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=3767</guid>
		<description><![CDATA[When it comes to product management, standard processes and theories work 90% of the time, but the last 10% is certainly an art. At Arena, we try to find a balance between listening to our customers, and looking ahead to see the possibilities of where technology is going so we can take the best advantage [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-full wp-image-3771" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/09/istockqr.jpg&amp;aoe=1&amp;q=100&amp;w=346&amp;h=346&amp;hash=bd7de7e0488d3250c332e064f384ef05" alt="QR codes on Tablet" />When it comes to product management, standard processes and theories work 90% of the time, but the last 10% is certainly an art. At Arena, we try to find a balance between listening to our customers, and looking ahead to see the possibilities of where technology is going so we can take the best advantage of it.</p>
<p>Our usual approach to product development is to address known application issues, then use customer requests for additional functionality to inform the design and details of future features. But in our last release, we included something you didn’t ask for—the ability to generate QR codes from <a href="http://www.arenasolutions.com/customer/how-to/videos/arena-smartlinks-demo">Arena SmartLinks</a>—a new feature in Arena that creates a static, unchanging link pointing to the latest effective revision of a document.</p>
<h2>Addressing the need for a paperless manufacturing floor</h2>
<p>The idea to provide QR codes did not come out of our normal process, but I believe there is an unrealized opportunity for QR codes on the shop floor, so I pushed to include the functionality. Manufacturers are becoming less paper-driven to improve efficiency, cut costs and reduce environmental impact. Scanners are already used for inventory control, and electronic documentation is increasing in usage on the shop floor. With the popularization of tablet computers, I believe this trend will accelerate, and QR codes will provide a great way to connect electronic documents to the real world.</p>
<p>Keeping documents current in a paper-dependent world can be challenging, especially as revisions frequently change. While all companies strive to maintain current documentation, for some segments—like medical device—documentation <em>must</em> be current. (FDA regulations for Good Manufacturing Processes (GMP) require all medical device manufacturers to remove down-rev documentation from their manufacturing floor.) Using a tablet computer for shop floor documentation combined with SmartLinks functionality could be one way for manufacturers to ensure that documentation is always current.</p>
<h2>How QR codes could be used on the shop floor</h2>
<p>With the ability to create scannable URLs, manufacturers can implement a point-and-browse experience on the shop floor.  For example, if work orders listing collections of parts included a QR code, a technician with a tablet could scan the work order, and immediately pull up the latest approved assembly procedure.</p>
<p>Manufacturers could also use this functionality to improve inventory management—with QR code-enhanced bins that provide a real-world bookmark for the latest specifications for each part.</p>
<h2>Predicting and addressing customer needs to inform product development</h2>
<p>As I said, the decision to adopt QR codes wasn’t obvious to any of us, but I used my “founder&#8217;s authority” to make the final call and add this functionality into Arena, even though there were no customer requests for it. As I said, there is a delicate balance between exercising your own judgment and listening to popular sentiment when designing enhancements, and in this case I went with my gut.</p>
<p>So what do you think? We’ve added a technology to the Arena application just because I thought it might be useful. Do you think this is a smart move? And do you agree that camera-enabled tablets will increase adoption of QR codes in manufacturing?</p>
]]></content:encoded>
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		<slash:comments>9</slash:comments>
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		<title>Documenting fixtures and jigs—why it’s forgotten, and why it matters</title>
		<link>http://blog.arenasolutions.com/documenting-fixtures-and-jigs/</link>
		<comments>http://blog.arenasolutions.com/documenting-fixtures-and-jigs/#comments</comments>
		<pubDate>Thu, 28 Apr 2011 19:24:57 +0000</pubDate>
		<dc:creator>Alex Gammelgard</dc:creator>
				<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Product Management]]></category>
		<category><![CDATA[Product Strategy]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=2320</guid>
		<description><![CDATA[I wrote a bit on Tuesday about the importance of documenting part information during the design process, and today I’d like to talk about another type of documentation that is commonly overlooked in organizations&#8212;the documentation of fixtures and jigs. We talk to many people working in high-functioning manufacturing departments who document everything thoroughly and consistently [...]]]></description>
			<content:encoded><![CDATA[<p><a rel="attachment wp-att-2322" href="http://blog.arenasolutions.com/documenting-fixtures-and-jigs/t-slots-on-the-table-of-a-milling-machine/"><img class="alignleft size-full wp-image-2322" title="T-Slots on the table of a milling machine" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/04/istock-fixture.jpg&amp;aoe=1&amp;q=100&amp;w=310&amp;h=205&amp;hash=ae126278ecba9faefac00659efa32f61" alt="" /></a>I wrote a bit on <a href="../../../../../why-engineers-who-hate-documenting-their-designs-should-do-it-anyway/">Tuesday</a> about the importance of documenting part information during the design process, and today I’d like to talk about another type of documentation that is commonly overlooked in organizations&#8212;the documentation of fixtures and jigs.</p>
<p>We talk to many people working in high-functioning manufacturing departments who document everything thoroughly and consistently except for the fixtures they use to make their product. Big mistake!</p>
<p>Failing to document your fixtures and jigs can cause huge problems down the road, so you need to make it a regular part of your process.</p>
<h2>Why do manufacturers forget to document their fixtures?</h2>
<p>Fixtures are important—they are the tools with which you build your product. So why do so many organizations forget to document them?</p>
<p>The most common reason is that fixtures can be built over time as needed, and are usually seen as “tools” and not “products”&#8212;because of this, many organizations forget to assign formal processes for them.</p>
<p>The perception that fixtures are a secondary concern begins early in an organization’s life. When a company first starts up things happen fast, and no one has time to worry about developing formal documentation processes for fixtures—especially if there are only a few people in the company. At this stage in the game things are very tactical, so plans and processes are implemented as an after-thought in the mad scramble to get products built and out the door.</p>
<p>In an ideal world, documentation for fixtures would be adopted immediately, or at least incorporated into the process as soon as your head is above water, but once things begin to stabilize fixture documentation usually takes a back-seat to hiring additional support and building out product lines. At this point a precedent has been set, and fixtures are typically forgotten until they break or need to be replaced.</p>
<h2>So you don’t document your fixtures and jigs—what’s the worst that can happen?</h2>
<p>Consider this scenario.</p>
<p>Something changes with your contract manufacturer and your only viable option is to leave. Of course your CM isn’t happy, but you’ve done the research and a continued partnership just doesn’t make sense. As you make the transition you do your best to capture all the information your new CM will need, but right after the papers have been signed you realize you’re not sure how to build an important fixture. (Or what more commonly happens is that you don’t realize the oversight until your fixtures break a few months or years down the road!)</p>
<p>Now this is a bad situation with two choices—reverse engineer the fixture, or crawl back to your former CM and hope they can help you recreate it.</p>
<p>The last thing you want is your engineering team out on the floor with calipers trying to reverse engineer a fixture—at $70-$100 an hour, this is expensive labor! An even worse possibility is that you can’t convince your old CM to help you out (even at a premium) so production stops.</p>
<p>If you’ve never experienced this personally, you probably know someone who has. It’s a high price to pay for something that is completely avoidable—if you document your fixtures and jigs.</p>
<h2>If you’re still not convinced you need to document your fixtures . . .</h2>
<p>With proper fixture and jig documentation, not only can you avoid line delays or stops, but you can find opportunities to eliminate waste in your manufacturing line, and become a more lean and efficient organization. And if you’re trying to decrease defects by implementing a Six Sigma or lean manufacturing strategy, the best place to start is with your fixtures—proper documentation allows you to see if there are errors or inefficiencies associated with your fixtures so you can make a change.</p>
<p>Even if you outsource your manufacturing, reviewing your processes, and keeping documentation up-to-date should be an in-house competency. Think of it this way—manufacturing is the only part of business where saving a dollar is making a dollar, so putting resources in place to understand and refine how your products get to market is a great way to improve your margins.</p>
<h2>For more information on documenting your fixtures:</h2>
<ul>
<li><a href="http://www.arenasolutions.com/jig-fixture-design.html">Why You Should Document Fixture and Jig Designs</a></li>
<li><a href="http://www.arenasolutions.com/finding-electronic-components.html">Tips For Finding &amp; Documenting Electronic Components</a></li>
<li><a href="http://www.arenasolutions.com/resources/dispatches/complete-bill-of-material.html">Everything Goes Boom: 3 tips for a complete AND correct BOM</a></li>
</ul>
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font-family: &amp;amp;amp;"><a href="http://www.arenasolutions.com/jig-fixture-design.html">http://www.arenasolutions.com/jig-fixture-design.html</a></span></div>
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		<title>Why engineers who hate documenting their designs should do it anyway</title>
		<link>http://blog.arenasolutions.com/why-engineers-who-hate-documenting-their-designs-should-do-it-anyway/</link>
		<comments>http://blog.arenasolutions.com/why-engineers-who-hate-documenting-their-designs-should-do-it-anyway/#comments</comments>
		<pubDate>Tue, 26 Apr 2011 18:07:20 +0000</pubDate>
		<dc:creator>Alex Gammelgard</dc:creator>
				<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Engineering]]></category>
		<category><![CDATA[Manufacturing]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=2281</guid>
		<description><![CDATA[You remember those friends in high school that didn’t like to show their work? I predict that many of them are now engineers. Most engineers I know see documentation as an obligatory and pointless chore, solely designed to take them out of ETAP or AutoCAD—and with that point of view, it’s not surprising they avoid [...]]]></description>
			<content:encoded><![CDATA[<p><a rel="attachment wp-att-2288" href="http://blog.arenasolutions.com/why-engineers-who-hate-documenting-their-designs-should-do-it-anyway/istockphoto_16319733-engine-blueprint-manufacture-industry-design-concept/"><img class="alignleft size-medium wp-image-2288" title="istockphoto_16319733-engine-blueprint-manufacture-industry-design-concept" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/04/istockphoto_16319733-engine-blueprint-manufacture-industry-design-concept-300x300.jpg&amp;aoe=1&amp;q=100&amp;w=278&amp;h=278&amp;hash=d5cd6a4b4e0f48c9ed040997cee1d9c2" alt="" /></a>You remember those friends in high school that didn’t like to show their work? I predict that many of them are now engineers. Most engineers I know see documentation as an obligatory and pointless chore, solely designed to take them out of ETAP or AutoCAD—and with that point of view, it’s not surprising they avoid it as much as possible. Yet proper part documentation is important, especially during the initial design phase. Without it, it’s much harder to go from prototype to production smoothly.</p>
<p>If you are an engineer who hates documentation, read on—here are some reasons why you should document your part information during the design phase of production, and a few tips about what you should document.</p>
<h2>Why you need to document part data during the design phase</h2>
<p>Simply put, designs don’t live in a spreadsheet forever—and when your product goes into mass production other people will need to be able to recreate what you did. For example, when a product goes from prototype to production it becomes the purchasing team’s job to buy parts in bulk so the product can be built in volume—if purchasing doesn’t take the wheel, a contract manufacturer (CM) will. If your purchasing team or your CM want to optimize for cost, lead time and part needs across projects, having detailed part information will make sure that the engineering requirements for your product are met.</p>
<p>Rigorous and consistent part documentation policies can prevent late-breaking component challenges, and make sure your designs get manufactured quickly and affordably. If your organization is fairly new to document control, here are some tips for finding and documenting components during the design and production phases.</p>
<h2>What part information you should be documenting</h2>
<p>As you are looking for parts, you should document part specifications and key part data along the way. If you belong to a small company, this information may be recorded on paper or in an Excel doc. If your product is highly complex, or if there are multiple people who will need to work with the part data, it is helpful to use an electronic data management tool. No matter how you choose to document your part information, you should at least be capturing:</p>
<ul>
<li>The manufacturer’s part number</li>
<li>The vendor name and contact info</li>
<li>The engineering requirements</li>
</ul>
<p>As you document the specifications of components that are critical to your product’s design, you may also want to take future needs into consideration. For example, where is the part in its lifecycle—is it still evolving? Is it mature? Is it being discontinued? Will demand for this component skyrocket<ins datetime="2011-04-01T10:24" cite="mailto:Alex%20Gammelgard">,</ins> making it even more difficult to source, or do you expect it to flood the market and drop in price?</p>
<p>These additional factors are not necessary items for documentation, but they may help your operations team keep production running smoothly later on down the road.</p>
<h2>Special considerations for hard-to-find parts and single source components</h2>
<p>If you are using hard-to-find parts or single source components, you should take a few extra precautions when documenting your parts. Since hard-to-find parts may be rendered obsolete by the manufacturer or removed from a vendor’s inventory without notice, you may want to find and document alternative sources.  If you are working with single source parts, you may want to form and document  a backup plan to handle worst case scenarios—like what should be done if your vendor has limited quantities or goes out of business.</p>
<h2>Do you have the proper tools for success?</h2>
<p>Properly documenting part information&#8212;<del datetime="2011-04-01T10:29" cite="mailto:Alex%20Gammelgard"></del>capturing the manufacturer’s part number, obtaining part spec sheets, recording vendor information&#8212;<del datetime="2011-04-01T10:29" cite="mailto:Alex%20Gammelgard"></del><del datetime="2011-04-01T10:29" cite="mailto:Alex%20Gammelgard"></del>will enable your internal purchasing team or your contract manufacturer to get the best possible price for parts and can even become a competitive advantage for your organization.</p>
<p>There are some tools that can help you properly document part and design information, like PLM or BOM management software. You may also want to consider storing part information in a component library like an EDA (electronic design automation) tool. A stable and well defined component library makes it easier to use easily accessible parts in your designs, or locate alternative choices for parts if the one you want is unavailable.</p>
<p>You don’t want to wait until a product reaches the manufacturing line to realize that it contains parts with procurement challenges or functional limitations, so document early on in the process. It takes much more time and effort to go back and fix documentation, or to deal with the consequences of poor documentation than it does to document product parts properly the first time.</p>
<h2>For more information on documenting part data</h2>
<ul>
<li><a href="http://www.arenasolutions.com/resources/whitepapers/dl/unexpected-product-costs.html">Three Steps to Cost Control: Addressing the Root Cause of Unexpected Product Costs</a></li>
<li><a href="http://www.arenasolutions.com/part-numbering.html">Part Numbering Schemes—Intelligent vs. Non-Intelligent</a></li>
<li><a href="http://www.arenasolutions.com/finding-electronic-components.html">Finding and Documenting Electronic Parts</a></li>
</ul>
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		<title>A three-step approach for controlling your product data</title>
		<link>http://blog.arenasolutions.com/a-three-step-approach-for-controlling-your-product-data/</link>
		<comments>http://blog.arenasolutions.com/a-three-step-approach-for-controlling-your-product-data/#comments</comments>
		<pubDate>Wed, 30 Mar 2011 00:26:13 +0000</pubDate>
		<dc:creator>Alex Gammelgard</dc:creator>
				<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Product Development]]></category>
		<category><![CDATA[Product Management]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=2159</guid>
		<description><![CDATA[We frequently hear about organizations that rely on the “old” way of doing things to avoid the perceived risks and costs of implementing a new system. But when it comes to managing your product data, maintaining the status quo can cost you in the long run, while the risk of evaluating and embracing new systems [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignleft size-full wp-image-2351" title="numbers-123blocks" src="http://blog.arenasolutions.com/wp-content/plugins/autothumb/image.php?src=/wp-content/uploads/2011/03/numbers-123blocks.gif&amp;aoe=1&amp;q=100&amp;w=154&amp;h=154&amp;hash=12450be8894ec1b0ceb7697d55b7e56b" alt="" />We frequently hear about organizations that rely on the “old” way of doing things to avoid the perceived risks and costs of implementing a new system. But when it comes to managing your product data, maintaining the status quo can cost you in the long run, while the risk of evaluating and embracing new systems is often rewarded.</p>
<h2>The unexpected cost of mismanaged data</h2>
<p>In a series of interviews with a small security device company, the manufacturing executives shared how their ineffective processes led to miscommunication and costly errors. The complete <a href="http://www.arenasolutions.com/resources/whitepapers/dl/unexpected-product-costs.html">story</a> can be found on our website, but here’s the basic idea:</p>
<p>Sales landed the deal of the year – a multi-million dollar contract that promised to be a game changer. In the scramble to fulfill the order, ownership of the BOM was never claimed and changes were often made ad hoc by phone or email. Eventually, the “master” version of the BOM was so unreliable that executives were forced to run regular checks to make sure it reflected what the contract manufacturer (CM) was building.</p>
<p>When it was time to fulfill the order, Purchasing received one version of the BOM, while the CM received a different version. With so many different BOMs floating around, the company purchased $50,000 worth of parts from the wrong supplier and missed an important change order, which led to a large delivery of the original unmodified, unusable configuration.  Ultimately the order was fulfilled, but revenue from the deal was eaten up by errors and delays.</p>
<h2><strong>Learning from the past to improve data management</strong></h2>
<p>After the dust settled, the company determined that storing product information in spreadsheets and sharing uncontrolled product data via email was no longer a viable solution. Although fine for documenting simple parts lists, Excel BOMs were unable to effectively document product changes or properly manage the critical handoff points – from engineering to operations and from operations to manufacturing and procurement.</p>
<p>While it’s impossible to erase past mistakes caused by improper documentation, organizations can fine-tune their processes and prevent expensive problems from recurring. In the case of the security device company mentioned above, the team learned from its mistakes and implemented better processes for managing product data and costs. Based on the improvement the company has seen, the executives we interviewed recommended the following three steps:</p>
<p><strong>Step 1.</strong> <strong>Control your CAD.</strong> Take the time to configure a product data management (PDM) system vault to keep your CAD data secure and revision-controlled.</p>
<p><strong>Step 2. Manage your BOMs. </strong>Invest in a collaborative bill of materials (BOM) management system (yes, full disclosure, like Arena) to ensure all parties are always working from the right version of the product record.</p>
<p><strong>Step 3. Plan for the future. </strong>Plan to grow into business applications like enterprise resource planning (ERP) and manufacturing execution systems (MES).</p>
<h2>Out with the old, in with the new</h2>
<p>There’s no time like the present to consider a new way of doing things – it could save you more than time and money. If you’d like to read the full story, and see full explanations of the above tips, please read the whitepaper <a href="http://www.arenasolutions.com/images/pdf/rc_docs/whitepapers/Arena_WP_Three_Steps_to_Cost_Control.pdf">“The Three Steps to Cost Control: Addressing the Root Cause of Unexpected Product Costs.”</a></p>
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		<title>Advice from medical device startups on preparing for an FDA or ISO audit</title>
		<link>http://blog.arenasolutions.com/fda-audit-tips/</link>
		<comments>http://blog.arenasolutions.com/fda-audit-tips/#comments</comments>
		<pubDate>Wed, 10 Nov 2010 16:00:22 +0000</pubDate>
		<dc:creator>Michelle LaVery</dc:creator>
				<category><![CDATA[Business Strategy]]></category>
		<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Document Control]]></category>
		<category><![CDATA[Medical Device]]></category>

		<guid isPermaLink="false">http://blog.arenasolutions.com/?p=1440</guid>
		<description><![CDATA[In our many years of working with medical device manufacturers, we’ve seen the rigorous work these companies do to pass a regulatory audit. Preparing for an audit is a time-consuming process that involves gathering, reviewing and updating process documents and ensuring that employees are fully trained on all company procedures. Needless to say, with their [...]]]></description>
			<content:encoded><![CDATA[<p>In our many years of working with medical device manufacturers, we’ve seen the rigorous work these companies do to pass a regulatory audit. Preparing for an audit is a time-consuming process that involves gathering, reviewing and updating process documents and ensuring that employees are fully trained on all company procedures. Needless to say, with their company’s success hinging on the outcome of the review, most find their FDA or ISO audit to be a nerve-wracking and stressful experience.</p>
<p>We interviewed three medical device companies&#8211;all of whom successfully managed their first audits&#8211;to get their take on how to prepare. All are Class II medical device manufacturers, and at the time of their audits none were offering predicates of their own devices, making it vital that they passed their inspections. All agree that if there’s an FDA or ISO audit in your future, you will benefit from taking the time to organize your procedures, documents and data in a clear and logical order. Their advice is described in detail in an <a href="http://www.arenasolutions.com/resources/whitepapers/dl/medical-device-companies.html">article on the Arena website</a>, but it can be summarized in the five tips below.</p>
<h2><strong>Preparing for an audit: Five tips for medical device manufacturers</strong></h2>
<ol>
<li><strong>Document your standard operating procedures (SOPs):</strong> Capture sufficient detail in your procedures to thoroughly document your activities.</li>
<li><strong>Train your people:</strong> Spend the time and effort needed to make sure your team understands and complies with regulatory standards.</li>
<li><strong>Control, track and manage your data electronically:</strong> Digital records of your processes, design history file (DHF), device master record (DMR) and bills of materials (BOMs) show your commitment to quality, accuracy and thoroughness.</li>
<li><strong>Audit yourself:</strong> Empower your internal auditors to make changes or hire a third-party service to perform a mock audit.</li>
<li><strong>Have the proof at your fingertips:</strong> The faster you can provide evidence to your auditor, the better his or her impression of your business will be.</li>
</ol>
<p>Following the steps above can help boost your confidence going into an audit and help pave the way for a positive outcome. <a href="http://www.arenasolutions.com/resources/whitepapers/dl/medical-device-companies.html">Read the full article</a> to learn more about how the three medical device startups successfully addressed the challenges they encountered during their own audits. And if you have any of your own tips on how to prepare for an audit, we’d love to hear them.</p>
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