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November 19, 2021by Chase Bodor

Most engineers approach risk management with a ho-hum attitude.

If you’re an engineer, then this probably isn’t your favorite task. For some, risk assessment is just a formality – a report passed around by different departments. So, you might take this routine easy, letting minor issues go untethered. This causes problems as those minor issues stack and becomes larger. As a result, the organization suffers a loss in both time and money.

Instead, you could avoid this with a well-executed risk assessment.

By addressing high-risk areas through a project’s lifecycle, you can save a company from disaster. This takes the hand of a seasoned engineer.

Are you about to launch a new injection molding project? Want to see how our team performs its risk assessments? Then buckle up! We’ll take you through our 9-Step Risk Assessment Process for assessing a new project request.

 

1: Part Design

For starters, most injection molded products follow a set of design rules. We call these Design for Manufacturing Principals or DFM. In essence, products that follow these guidelines are easy to produce and offer other molding benefits. This includes reduced scrap rate, less material use, and quicker production cycles.

The first thing we do is evaluate a drawing (or CAD) we receive for manufacturability. This process starts with looking at the product’s geometry. We do this to identify any details that are “difficult to mold”.

For example, wall thickness is one common design flaw we find in drawings. A thick wall can cause product deformation in the form of sink. And deformed products are destined to fail in the field, so we don’t want to encounter that issue!

Similarly, critical dimensions with tight tolerances are tricky. This is because of plastics’ ability to shrink. To clarify, as the product cools it shrinks based on the material’s properties. As a result, the product can shrink past the print’s callout. Of course, this is harder to avoid but doesn’t prevent us from making the product.

Instead, a subtle design change in the early stages will negate this issue before incurring avoidable costs. The result: good product with minimal engineering costs.

If you’re unsure about your part design, you can work directly with us to work out any questions you might have. Alternatively, you can look at conducting a mold flow analysis– a program that simulates how the design will fill in an injection molding environment.

 

2: Materials

Not everyone is an expert in material science, and you don’t need to be. But having a good understanding of the material you are working with goes a long way towards reducing your risk. You should identify whether the material you want to use is compatible with the application. Otherwise, the consequences of purchasing the “wrong material” can set your project back financially and timewise.

One of the obvious questions you should ask yourself is: “Does this material’s physical and chemical properties meet all my engineering requirements?” In other words, you’re asking yourself whether the material will work under the product’s normal operating environment. You can’t run plastic that has a low melting point in a high heat environment… It’s going to fail. But you already know that!

While that last example might be a no-brainer, some questions don’t come as easy. Here’s our top 3:

  1. Material Availability – What does the availability of this material look like? Supply chains are as fluid (and unpredictable) as ever these days. Also, some materials require a Minimum Order Quantity (MOQ) which can impact the cost.
  2. Process Compatibility – This comes into play with secondary processes such as over-molding or ultrasonic welding. Does the material you selected play well with others?
  3. Dimensional Stability – Does your product require tight tolerances? Well, a well-known quality of plastic is that it shrinks! The amount that plastics shrink varies between each material and each formulation. Just something to keep an eye on!

Ultimately, your best resource for plastic is a materials supplier. Our network of materials suppliers can offer design guides, datasheets, spec sheets, and more. We often involve these suppliers early in the process just so we have all the necessary information in hand and can eliminate potential risks.

 

3: Tooling

When looking at risk assessment for a new mold build, we exercise a lot of information from other areas that were covered in the previous sections. This includes part geometries, material selection, and labor usage (see automatic molds vs operator-required molds). The goal at this stage is to confirm that the mold’s capability matches the project’s requirements in terms of value, volume, and efficiency.

For instance, one way we facilitate harmony between reality and expectations is through production volume. If your annual production volume is less than 25k parts, then you’ll likely want a prototype quality tool. In contrast, if you’re looking at +1 million parts, you’ll want to upgrade into production tooling to avoid doubling down on your mold investment.

Another great point is building the mold with the right materials and features. When we talk about steel materials, we look at the chosen material’s physical and chemical properties. You don’t want a glass-filled material running thousands of shots in an aluminum mold because it will wear faster. With mold features, you can underestimate the labor cost of a mold with multiple hand loads and other manual-intensive features.

Plastics Plus manufactures all its tools to SPI specifications. And because any tooling built and retained is maintained at no cost to the customer, it is in both of our interests to conduct a full risk analysis and mitigate any risks before turning on the build.

 

4: Labor

Labor might not strike you as a risk factor. But the truth is – labor can be sneaky and costly when unaccounted for. There are a few circumstances where we try and address any labor risks, so let’s dive a bit deeper.

Part and Tool Design: good manufacturing design principles will tell you that fewer components in any given assembly are ideal for manufacturing. How does this relate to labor? Well first, more components will require more labor-intensive activity like degating, deburring, trimming, machining, welding, and more. This introduces the possibility of variation and mistakes in handling the product.

Then, we must consider the risk with the actual assembly of the product. The further along down the production lifecycle, the more valuable the product is and the more expensive it is to lose on defective parts. Ultimately, we look at the risk associated with performing the entire assembly along with the possibility of not having enough people to do them. This is especially an issue with the current labor shortage.

For tool design, we look at whether the tool is automatic or not. The question we ask is “does an operator need to stand in front of the machine to do XYZ”. If not, then the machine can run without operator supervision (aka does not use labor resources). If the mold has multiple features, like hand-loaded inserts, then that requires much more labor.

Physical Injury: Good Manufacturing Practices (GMPs) and OSHA standards cover most common workplace accidents, and we value injury prevention as much as any manufacturer. But as we mentioned above there are inherent injury risks present with labor. And the injury doesn’t always happen at work. An injury can occur on the factory floor, or it can occur outside of work during a pickup game at the YMCA. Either way, injuries are a risk we must consider as it contributes to a strained workforce.

*Just a note: we rotate positions on our production floor for this reason. It’s unlikely someone will sustain a serious injury, but it’s a risk that is still present.

 

5: Equipment

Equipment failure isn’t something we run into often. However, the inherent risk with unplanned downtime due to equipment failure must be considered in the risk assessment. Unplanned downtime due to machine failure or mold damage happens for a few reasons: One – the equipment runs past its expected lifetime and requires repair or replacement. Two – the machine does not function as intended because of numerous factors. To prevent the latter, we test and validate our processing procedures to reduce human-caused errors. Furthermore, we keep a detailed maintenance database to check the pulse on all our equipment.

Another risk we consider is sourcing a new piece of equipment. For example, a new project might require a minor investment in equipment such as a fixture. Another might require us to buy an entirely new piece of production equipment like a heater or dryer. In either circumstance, we are at the mercy of our supplier. If the lead time on that equipment is extensive that poses a huge risk to the project’s timeline. Under those circumstances, the cost due to lost time can result in thousands of dollars. Therefore, we do our due diligence to ensure that we receive and can operate the required equipment for your project.

 

6: Packaging

By working with Plastics Plus, you have the option to produce a finished, packaged product. In other words, your product can be molded, assembled, and packaged all under our roof and shipped to you ready for market. This is a great advantage for you as the product owner, but it doesn’t come without risk.

The risk in packaging is a combination of a few other risk areas that we’ve covered in this article. For example, let us examine the packaging equipment. A complex packaging machine can do a few things at once: unroll, print, open (with air), and seal the package within a single cycle. Any variation in this process will impact the quality of the packaging and potentially the product. And any machine failure will result in unplanned downtime. In either case, the result is a loss of time and money.

Now let’s look at this from a materials standpoint. As with most supply chain constraints, not being able to source the packaging is the primary risk. The secondary risk is sourcing poor-quality packaging that doesn’t meet either of our standards. If we added a third risk, it would be scrapped packaging. All three of these situations pose a risk to our operations. But more importantly, it poses a risk to your bottom line which is what we are aiming to improve in the first place. Before we jump into one more area of packaging risk, we should remind you that our quality system is designed to prevent the poor product from ever reaching your doorstep. Thus, you can be confident will address any major concerns upfront.

No one likes to be blindsided by poor foresight.

Since we mentioned shipping to your doorstep, we should address the risk with shipping products. When we ship products via courier there are a few things that can happen. For instance, products on long-hauls can be damaged on their route because of poor handling. Nevertheless, we contract with major courier services to ensure that a professional is handling the product. Ultimately, the risk here is minimal but needs to be considered as part of our process.

 

7: Application

Application, or the end-use of the product, is one of the most important portions of our risk assessment process. We need to collect as much information on the use of the product and the environment as possible. During our initial conversations, we will expect to learn exactly who the end-user is and what the impact of the product is. Furthermore, we will want to identify the level of safety (or danger) for the user. On a similar note, we will consider whether the product is fit to function in its intended application.

For example, products that come into direct contact with a medical patient (such as a cannula) carry a higher risk factor than a plastic clip. Similarly, if the component is critical to the operation of an assembly or device (such as a CPAP) then the risk is also high.

Comparatively, if the product does not interface with the user and has low criticality then the risk factor is lower. Nevertheless, we still evaluate whether the product can be successful in its normal operating environment. Just because the risk for injury or death is low, we still want to prevent product failures. In this case, we’ll look at the fit and function of the part from an engineering and materials standpoint to identify any red flags. Ultimately, it is your job to determine whether the product is fit for purpose.

For review, we covered three application risks in this section:

  1. Risk to the user
  2. Risk of criticality
  3. Risk of fit for purpose

Next, we’ll cover risks associated with compliance and quality requirements.

 

8: Regulatory Compliance

Regulatory compliance isn’t necessarily a risky undertaking for most projects. FDA compliance, GMPs, and other regulatory/ statutory requirements are handled primarily on your end. But we often abide by the same requirements to give our customers a seamless experience. However, these requirements prove to be more stringent for some products than others. Some of these falls outside of our capabilities, namely controlled molding environments and ISO-certified clean rooms. Under those circumstances, we avoid risk by turning the project away. On the other hand, we assess projects within our capabilities and determine the risk of falling out of compliance. All things considered, our quality department ensures that our party abides by all requirements laid out by you, the customer.

 

9: Special Quality Requirements

Validation is a staple in any robust Quality Management System (QMS). This is a multi-step, cross-departmental function in most manufacturing companies. It proves the capability of the methods machinery used to produce, measure, and test the manufacturing outcomes. In other words, the quality requirements set forth by the customer are fulfilled through validation procedures.

When we consider the risk inherent in those quality requirements, we look at the capabilities of our staff, equipment, and processes. These risks are like those present with regulatory compliance in that every product is a bit different. The first thing to consider is whether we can meet the proposed quality requirements. Some products carry tight tolerances in their drawings, critical dimensions that are unavoidable. Although we specialize in close-tolerance injection molding, we encounter some dimensions that are outside our capabilities. Once we establish competency to meet those requirements then we show our proof in the pudding. Explicitly, we’ll run our tests (IQ, OQ, PQ) and conduct others as required (PPAP, MSA, DOE, etc.).

If you want more information about our quality procedures, you can follow the link here.

 

Conclusion

By now, you should have a grasp of all the elements of proper risk assessment. Congratulations! You’re on your way towards approaching risk like a seasoned pro.

Good luck with your next project! Contact us if you need help conducting a full risk assessment on your next injection molding project.

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April 27, 2021by Chase Bodor

Since its invention in the ’60s, the copy and paste function has been a vital time-saving business tool.  With this tool, businesses eliminated repetitive work that was already done before. In other words, they didn’t need to reinvent the wheel again and again. What better time-saving shortcut is there for a business? Well…

What if I told you that there is another version of copy and paste. This version actually doesn’t make life any easier for your business, or yourself. In fact, this version of copy and paste steals the very idea or product that has taken you months, even years to build. And unlike on a computer, there is no undoing it. All your hard work is copied and pasted in an instant for someone else’s profit.

This is the danger of IP theft in outsourced manufacturing.

As we go further into this topic, we will discuss how IP theft happens in the big picture. First, we will talk about the different agents involved in stealing business IP. This is also known as industrial espionage. Then we will cover the ecosystem of outsourced manufacturing. White label manufacturing plays a big role in IP theft and is worth studying in this context. Following this section, we will look at some basic principles of protecting your company’s IP. Finally, we will talk about why trustworthy relationships go a long way towards protecting your IP. This includes a conversation between myself and a product design firm.

 

What is IP theft

According to the FBI (who I believe is credible for this topic), IP theft is stealing peoples’ and/or companies’ ideas, inventions, and creative expressions. These are intellectual properties- which include trade secrets, proprietary products, and media engagements. 

There are four main types of IP:

  1. Trade secrets
  2. Trademarks
  3. Copyrights
  4. Patents

IP theft is becoming a more prevalent issue as digital technologies and Internet file-sharing networks integrate into major business operations. For example, sensitive information transferred over the web is a prime target for internet hackers. We will discuss the different scenarios in which IP theft occurs later in this segment.

In general, IP theft happens more where trademark laws are less defined and harder to enforce. For example, overseas companies are major offenders of  US-based IP theft. In fact, Chinese theft of American IP costs the US between $225 billion and $600 billion annually. These numbers are from an investigation led by the United States Trade Representative. Additionally, those numbers match with a 2017 report from the Commission on the Theft of American Intellectual Property. As you can see, IP theft can result in serious economic damage and can stun business growth.

 

How does Ip theft occur?

There are many opportunities for thieves to steal intellectual properties. For instance, internal and external data mining can reveal lots of sensitive information. In other words, protecting your IP is not as simple as locking your front door and buying an SSL certificate for your website. We will discuss some best practices for protecting your IP later on. For now, let’s jump into who engages in industrial espionage and how they extract information.

 

The common IP thief

The internal agent: Someone who steals/ reveals their company’s IP from the inside. This person is someone who joins a company with the sole intent of spying to gain information. In other words, they were working for someone else all along. These internal agents can release sensitive data about your company. They can also hinder its competitive edge by taking proprietary tools. 

A disgruntled employee is another common IP perpetrator. This person takes revenge on his or her company for their perceived wrongdoing. They can also talk their peers into sabotaging the company from the inside if they’re persuasive enough. As a result, you may have many internal seeds working to compromise the company.

An expert moving within an industry is also a threat to intellectual property theft. Although less common due to non-compete agreements; someone can move companies within an industry and take some of the IP with them. Although this isn’t illegal in some cases, there are moral implications with this behavior.

And finally, there is always a potential for inside information to accidentally leak out. This happens when someone from inside the company sends information across unsecured channels. Or to the wrong recipient entirely. 

External Agents: Someone who infiltrates your company’s data through hacking or other forms of unsolicited collection. People who work in an office setting will come across many attempts to steal information. The most known methods: phishing, hacking, etc, are disguised well to imitate a familiar transaction. In fact, these information heists mimic high-profile people within a company. They will ask the receiver to send sensitive information with urgency. If successful, these attempts are devastating. And the recovery from such an event can take years if they recover at all. This is why having protected channels to send information is so important.

 

Common IP theft scenarios

Let us review some common scenarios where IP theft can occur:

  • Internal Agents
  • Leveraging privileged access 
  • Spys/ investigators
  • Disgruntled and persuasive employees 
  • Accidental information leak
  • External Agents
  • Hacking/ phishing
  • Surveillance
  • Data mining (including paper trails)
  • Security breach

 

How does IP theft affect me?

For those who are still reading and think “oh this will never happen to me or my business” think again. Many small and medium-sized businesses are targets of scammers, hackers, and IP perpetrators. And your company’s books aren’t the only thing they’re after. They are after anything they can pull from you and use for their own gain. If your company owns IP or holds customers’ IP, think what can happen if those “secrets” are in the hands of someone who can re-engineer it for themselves. 

Let’s look at this from the lens of a manufacturer– a business that manufactures goods for sale either for themselves or for other companies.

 

How is outsourced manufacturing involved?

Manufacturing plays a significant role in IP theft. As hinted earlier, a manufacturer holds an entire portfolio of IPs.  And holding these different properties gives the manufacturer a ton of responsibility. This responsibility isn’t always held close with a moral compass either. You will find some manufacturers steal ideas, products, and technologies from their clientele. They then reintroduce those products into the market under a different brand. 

In this next section, we will discuss what role outsourced manufacturing plays in IP theft. Also, we will discuss two manufacturing methods: White Label and Contract Manufacturing. While the two share some similarities, they both pose some risk to a company’s IP.  Furthermore, we will explore what a Copycat Manufacturer is and its role in IP theft. In the end, we will transition into some helpful ways to protect your IP.

 

White Label Manufacturing vs Contract Manufacturing

What is ‘white label’ manufacturing

White label manufacturing is a popular option for outsourcing manufacturing. In this process, a retailer or brand hires a manufacturer that produces a product they want to sell. The retailer purchases the product and slaps its label onto it. The idea behind this is a well-recognized label can make it look like it produces its own product line. When in reality they buy their product at wholesale prices from a manufacturer. To summarize, a white label manufacturer makes its own products but makes them available for sale to retailers. At the same time, the manufacturer can use its own sales channels to sell that product to other retailers or consumers.

 

what are the differences between white label and contract manufacturing?

A contract manufacturer is different from white label manufacturers in a few ways. For example, companies hire contract manufacturers to produce parts, components, or final products. The hiring firm first establishes the design specifications that the manufacturer must follow. Then the manufacturer orders the necessary consumables and runs its processes. Based on the agreed terms, the manufacturer produces a set number of parts over a specific timeframe. Once the manufacturer fulfills the order, the parts get shipped back to the hiring firm. At no point does the manufacturer sell these parts under their own, or any other label. In fact, both parties enter into a contractual agreement that protects their interests. This agreement involves sharing intellectual properties, designs, processes, and more. To learn more click the links here on contract manufacturing and NDA’s.

If you didn’t pick up on it, I will tell you the big difference between the two types. The big difference between contract manufacturers and white label manufacturers are:

  1. White label manufacturers can make and sell products as their own.
  2. Contract manufacturers make parts exclusively for another business.

Although this doesn’t seem like a huge revelation, there are a ton of implications. For one, the white label manufacturer can take a “new” product to market with little effort. 

Remember what I said about the moral compass?  Well… 

There are examples of overseas manufacturers that take someone else’s product to market. To put it in different terms, these manufacturers rip off an idea and sell it as their own. Whether IP is explicitly stolen, or they create off-brand products meant to mimic a large national brand; this process breeds something called Copycat Manufacturing.

 

Copycat manufacturers

A copycat manufacturer takes a product or idea and spins it to make it look like their own.  They even will clearly rip off the existing product label to trick consumers into buying their product.  For example, a copycat will keep the same branding as well-recognized products. This is so consumers will think highly of the product and choose it based on the discount price.

A great example here shows the many knockoff variations of Dr.Pepper.

Copycats are a huge problem in the manufacturing space. These manufacturers not only copy well-performing products, but they hurt the value of the existing products. 

Not only that, there is a huge negative impact on the US and global economy. The International Chamber of Commerce estimates that counterfeit products and stolen IP will negate a total of 4.2 trillion US dollars from the global economy by 2022.

To bring the point back around, not all white-label manufacturers steal IP and create their own product offerings. But, the ones that do are playing a huge role in this micro-chasm of stolen IP-turned rip-off products. This is the risk you run by not protecting your intellectual properties. And also by working with an unvetted manufacturing partner.

Now you understand the risks of unprotected IP. Next, let’s look at some ways you can stay vigilant and protect your business.

 

Managing the Risks of Outsourced Manufacturing

IP Security Screen

Is my IP at risk if I outsource manufacturing?

The short answer: yes.

But the risk of getting duped by a manufacturer you know and trust is quite low. The arrangement between producers and sellers is a time-tested affair that has worked for most businesses. The key to this relationship has been, and always will be, trust. 

While working with a circle of manufacturers you trust is important, you should still protect your IP. If someone steals your business’s IP, it is very hard to find and prosecute the thieves involved. And there is no telling how long it will take to recover your IP.

In this next section, we will cover some helpful tips for keeping your IP safe.

 

How do I protect my business from IP theft?

To keep your business IP safe follow these six principles suggested by Awake Security:

  • Identify Your IP
    • Identify exactly what information you want to protect and from whom to protect it. Through this exercise, you can align your leadership group with your security goals.
  • Locate Your IP
    • Without locating where your IP sits (IT systems, file cabinet, you name it) you won’t know how to protect it. Because we’re looking at this in the context of manufacturing, you will want to audit your third-party systems as well. This includes ERP systems, product catalogs, technology stacks, and more.
  • Conduct a Risk and Cost-Benefit Analysis
    • Do you know how much it would cost you if you were to lose your high-profile assets? Do you have a priority list when it comes to IP? If not, this exercise will help you identify which assets will cause the most harm if they were lost. Also, this will help you identify where to invest in security systems to prevent a large loss.
  • Educate Employees
    • Help the people in your organization understand what IP is at risk of exposure. By educating your team they can better protect and prevent IP breaches from happening.
  • Identify Protection Gaps
    • There are many opportunities for a thief to attack your business. Auditing your systems by thinking from an attacker’s point of view is an excellent way to identify any gaps in your current system. Once you’ve identified some areas for improvement put on your thinking cap! Start with small adjustments and aim for continuous improvements. Also, consider making investments in your security to boost your protection.

 

What to Consider for Your Manufacturing Partnership

Choosing the right partner is time-consuming and has an incredible impact on your company’s success. But, not all manufacturers are created equal. That’s why vetting your potential partner is an essential step before doing business.

Before you put pen to paper- consider looking into your potential partner using these criteria:

  • Location:
    • The location of your supplier is a huge consideration when you factor in time-to-delivery and responsiveness. Working with an offshore manufacturer might cost less upfront. However, I’m biased to working with domestic partners for several reasons. For one, you have more visibility into your supply chain. Second, you can communicate in your own language. This is key when situations arise that can be problematic. Choose the location of your next supplier wisely.
  • Capabilities and Experience:
    • Would you choose the world’s best Sous Chef to cater for your company party? Maybe, but they probably aren’t the best choice. Choose a supplier who has an ample amount of experience working in your field. This will make the process seamless and your communication clear cut. They’ve worked with companies like yours before so they know the challenges you face.
  • Check references:
    • This and the item above go hand-in-hand. Check references with other companies who are also supplied by the same manufacturer. Most of the time, these companies will have a scorecard, approved supplier list, or at least some nice words to say.
  • Labor Practices:
    • Again, working domestically helps mitigate some best labor practice issues. Evaluating the working environment of your supplier will give you some insight into the culture of the company. Also, this will help you understand how they treat people inside and outside the company. Red flags? This is a sign that you might run into issues down the road.

To wrap this up, we would love to start a conversation about a potential partnership. If you’re looking for an experienced injection molder based in the US, then look no further than here! With over 40 years of experience, we’ve helped many companies with their projects. Plus, we keep a tight ship over here. So you can trust us with your intellectual properties. Give us a call and see how we can address your molding challenges!



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Plastics Plus Technology is a woman-owned, USA contract manufacturer based in sunny Southern California. Our custom injection molding and value-added services can provide you with a one-stop job shop for all your injection molding needs.

ISO 9001:2015, ISO 13485:2016 Certified. FDA Registered. Good Manufacturing Practices (GMPs). WBENC.

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