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January 30, 2023by Chase Bodor

The validation process is like a charcuterie board of overhead costs… And if your quality requirements are stringent – you’re going to need an appetite.

When looking at the overall cost of an injection molding project, it’s easy to quantify and even justify the costs of upfront tooling. Same with the price per unit of each part. But when we start talking about validation processes, things are not always as clear. Therefore, costs can easily begin to compound when the process is not monitored and carried out properly.

First, you want to have the right people.

Validating new products and components requires oversight from Quality and Engineering SMEs. These experts are no slouches – often leveraging specialized skills in processing, measuring, data analysis, and other high-value skills. Their time and knowledge are worth their weight as long as the processes and systems they have to follow can make the best use of them.

That’s where having the system to test, record, assess, and the document becomes so valuable.

It will help you plan, check, and monitor your expenses throughout the validation process. This allows you to make quicker, more informed decisions to stay on budget.

If not, then validation overhead could end up being a significant (or even the biggest) cost driver. You don’t want this process to eat up all your budget.

đź’ˇ Here are 8 ways you can keep your validation overhead controlled:

🔎 Utilizing industry standards and guidelines for validation, such as ISO 13485 and ISO 9001, to ensure that all necessary validation processes are being followed.

🚨 Implementing a risk management process to prioritize and focus validation efforts on the most critical aspects of the device.

🚌 Streamlining validation protocols and procedures to minimize duplication of effort and increase efficiency.

đź’» Automating validation testing and record-keeping, using electronic systems to reduce manual errors and increase accuracy.

🔎 Continuously evaluating and improving validation processes to ensure that they are current and effective.

🤩 Outsourcing validation services to third-party providers, which can provide specialized expertise and resources.

🔧 Using a modular approach in design, where different parts of the device are validated separately, which can reduce the overall validation effort.

đź“„ Utilizing device history records, which can provide a detailed record of the device’s history, which can be used to demonstrate compliance with regulatory requirements.

If you struggle to accurately control your validation processes and you’d like to chat about how to improve your process – reach out to us! Plastics Plus Technology operates a QMS that strictly follows ISO 9001:2015 and ISO 13485:2016 requirements.


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May 4, 2022by Chase Bodor

I recently stumbled upon “The Iceberg Problem”

It is well-known to software developers, but it isn’t unique to just them.

Manufacturers have an iceberg problem too.

This idea originates from the process of building custom products or services for customers. With any custom project, there is a chance for misaligned discourse between what the customer thinks they want and what the contractor perceives the customer’s needs are. This can be frustrating and even painstakingly miserable for both parties.

The common cause – most times customers don’t understand the complete process.

Like an iceberg – 90% of manufacturing happens beneath the surface. The other 10% is what the customer perceives to be the result of the work being done.

When you present the work to the customer:

  • They care about the looks – does it match their vision?
  • They care about the performance – does it works as intended?
  • They care about how much it costs them – did the budget align with their expectations?
  • They care when they will receive their order – does it match their timeline?

And that’s it. That’s the 10%.

How can that be? From what I have gathered, there are a couple of hang-ups that drive a wedge between the customer and the contractor.

1. Sending in a sample that is less than ideal visual quality

When manufacturers validate a process, they just want to prove that the process is capable of making the product according to the outlined requirements. Sometimes, this sample doesn’t look visually perfect. And when the customer receives their product they are taken back.

The problem isn’t in the quality. In this case, the expectations were not set properly for your customer. You have opened the window for the customer to question the quality of your work. When you go to explain that it will take some time to get a sellable product, then a bit of dissatisfaction creeps in. Is this partnership going to work out? Can this company deliver on its promises?

That of course is for you to answer. But it helps when you establish the expectations upfront.

2.  Showing off a finished product does not mean the work is done

Let’s say that the new project has gone through the initial inspection and the resulting parts look great. The first article samples are shipped to the customer, and they are ecstatic. They are ready to place a purchase order for their first production run. Oh, by the way, they need thousands of pieces by the end of the month. HOLD THE BUS! There is still some work to be done to ensure that the process is repeatable and that the equipment is production-ready. They may say “what do you mean, you already sent us good parts!?”.

This is where the iceberg analogy and the idea of above/ below the surface shows its teeth. Above the surface, we have stellar results. The product looks and works great. In the customer’s mind, the majority of the work is complete. But beneath the surface, the process that goes into making that product has to be refined. This often involves training, experimentation, oversight, data capturing and analysis, capital investment, and a whole lot more. Here’s the point – just presenting the results means leaving out everything it takes to get there.

3. The infamous design change midway through the project

There’s nothing that screams “we don’t know what we want!” like a down the value-chain design change.

Now, prototyping is part of the game, we get that. But the amount of work that goes into diverting from the original plan, especially when there are huge capital investments involved, is daunting. While the customer just wants what they think works best for them. But these changes are not subtle, cheap, or quick. These are the types of changes that can make a project stop in its tracks, or at least slow it down.

4. Costs that are hiding in plain sight

Quoting a new project isn’t a straightforward matter. What makes it complicated is when the project budget rises as more labor, equipment, overhead, and time is introduced. Focusing solely on the end price for the product highlights the 10% and completely ignores the work done underneath the surface – the “body” of the iceberg. Below the surface, there are other costs that appear as the work matures. But manufacturers don’t want to spin customers around by scavenging every nook and cranny for pennies. Instead, they often spread these costs across different areas to present a more digestible bill. Some of which are not even passed down to the customer, even if it’s at the contactor’s loss. By the way – we must make some money too.

5. Waiting at the shipping dock wondering when parts will show up

From the time the purchase order is processed until the product is on the truck – manufacturers are diligently working. But sometimes there is a bottleneck in the process that puts us in a holding pattern. It would be a Shakespearian world if this was something we can control but ultimately it is not. Because of supply chain interruptions, labor availability, vendor-driven pauses, and other things that cause unplanned downtime, there is always a chance we miss the deadline.

Here’s the thing – we can’t control everything but we can at least communicate. More times than not, the customer would rather know that a machine had to be sent out for repair and the lead time will have to be adjusted than to be left out in the dark.

 Addressing the problem going forward

So how do we address these key points? The answer isn’t simple, but it can be done through a roadmap for continuous improvement. Start with a detailed schedule to set expectations from the start. This will help keep your team and customers on the same page. Next, bring your customers in on the process and educate them. Show them the work that goes into creating the product and they will be more understanding when you want to solidify your processes. Another thing you can do is be a more effective communicator. Communication is always a challenge, but by improving this aspect of your business your customers will be better informed. Not only that, but they will appreciate your willingness to be transparent. And finally, deliver value anytime you talk about costs. When you focus only on price and don’t show everything they get in return, then customers will fight you on costs.



December 19, 2018by rpothier

Tariffs have increased the cost of buying products from China.   Components commonly used in injection molded products have been affected as well.  These components include terminals that are used in electrical components, various inserts and other materials produced in China.  At this time the tariff adds approximately 10% to the cost of the good sold but this could increase to 25% after 2019. Raw materials such as steel have higher tariffs.

A tariff of 25% on Imported Chinese steel has also been put into place.  This added cost is cause for concern to molders who use imported Chinese steel to build their tooling. Naturally the injection mold industry is heavily dependent on steel for the production of their tools, for small precision close tolerance molds the raw material cost is only 10% of the total mold costs.  Steel cost is a larger percentage of the cost for Large molds and molds that have less stringent quality requirements.  For those molders who import finished mold tooling, the cost could be much higher, adding upwards of $10,000 to the mold cost. The good news is that the tariffs on steel produced elsewhere have been lifted.   Steels produced in Mexico, Canada and Europe are not affected by these tariffs.

PPT works with local sources for tooling and materials so thus far we have not seen a big impact on tooling costs.   Inserts however are another story, early in 2018 we immediately began to see tariff costs passed down from suppliers. Where possible,  we searched for alternative sources for inserts and terminals that could be produced in the USA or Mexico.

While it appears that both China and the USA will eventually agree on a new trade deal, nobody can predict when.  Until then, there will be pressure to use alternative sources produced anywhere but China.

 

 



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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 plastic manufacturing needs.

ISO 9001:2015, ISO 13485:2016 QMS certified and compliant. FDA compliant. Good Manufacturing Practices (GMPs). WBENC.

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