Audits of quality systems are required in the medical device industry—but are you conducting your own internal audits on a routine basis? Are you including your packaging operations?
Internal audits at planned intervals are expected under 21 CFR Part 820 as well as under ISO 13485. Speaking at HealthPack 2017, John Derek Thompson, lead sterile packaging operations engineer for DePuy Synthes, encouraged attendees to conduct them regularly. He offered a “toolbox of tips” to help attendees be more actively “compliance self-aware.”
Thompson began by explaining that developing an auditor’s eye is “a tool of compliance self-awareness.” For instance, for “every action you do and everything you write down, you should ask yourself, ‘how would this look to an auditor’?” he explained. And then “you must present objective evidence of how the right thing was done and how the risk of not having done it right was mitigated.”
Thompson said it’s also important for packaging professionals to ask themselves and their team the right questions while generating these documents: validations, SOPs, maintenance records, change control, non-conformance reports, and CAPAs.
Risk is a core concern throughout all these activities, so Thompson advised packaging professionals to ask these questions as a real-time compliance check:
- What is the identified risk?
- How does this action mitigate the identified risk?
- What are performance indicators to demonstrate that the risk has been effectively mitigated?
- Is there a system in place to effectively monitor established processes?
- And is there objective evidence for all the above?
When writing validation reports, professionals should ask themselves and their teams these questions:
- Are the results immediately apparent? (“Don’t make an auditor search or wait until the end of a report for the final outcome,” Thompson said.
- Have all identified acceptance criteria defined in your preapproved protocol been met?
- Does the first page of your protocol summary state the following clearly: the validation activity and the results, the original intent of the protocol, whether acceptance criteria have been met, the major equipment validated, and clear pointers to objective evidence provided?
- Is all data clear and legible?
- Have all test methods been validated?
- Have all measurement devices used been calibrated?
- Are all training records documented for those recording data or approving the protocol?
In terms of designing SOPs, Thompson said it’s important to consider whether work instructions are clear and straightforward so that people who know nothing of a company’s process can follow them. For instance, are there clearly stated steps and output expectations as well as procedures for handling unexpected results?
Maintenance schedules and records for validated equipment are also expected under 21 CFR Part 820, so companies should audit these procedures and be “compliance self-aware” in their design, he said. For instance, is it clear as to who is responsible for executing routine tasks? Are tools or materials defined and available to mitigate risk? Does routine equipment maintenance include a verification step to ensure a return to a validated state? What about standard risk mitigation during unplanned maintenance?
Thompson also urged the audience to consider their procedures for documenting nonconformances and CAPAs. For instance, packaging professionals should ask themselves as they document a nonconformance whether someone unfamiliar with their processes can determine from records what the nonconformance was and who it involved, what the outcome was, and how the issue was immediately contained.
He also told the audience to avoid these indefinite types of words in their CAPA reports: usually, mostly, typically.
Finally, companies should have a “compliance mind” for their procedures in place for validated-system change control. Thompson advised the audience to ask themselves whether there is a process in place to determine the level of system change required (e.g., critical, moderate, or minor) based on the risk to the validated state and what steps need to take place at each level. “Define system levels and change requirements in the original validation,” said Thompson. “You may not be able to capture all cases, but all reasonable ones should be listed with requirements for verification testing or revalidation following changes to them.”
Referring to all these activities, Thompson told the audience: “Remember that in all your documentation, you are giving an account of events that an auditor was not present for. Each document should tell a complete story and leave little or no doubt that the outcome was what was intended and the risk of deviation was mitigated through robust design and effective monitoring.”
He later told PMP News that: “An audit is after the fact. The intention is to maintain an auditor’s eye while you carry out a task, rather than waiting to have it reviewed later for compliance assurance.”
He encouraged the audience to join the Packaging Operations Technical Subcommittee of IoPP’s Medical Device Packaging Technical Committee. Thompson is chairman of the subcommittee. More details can be found at www.iopp.org or by contacting Thompson at email@example.com.
To learn about the “Next Big Thing” in healthcare, check out this conference at the upcoming BIOMEDevice Boston event on Wednesday, May 3:
“The Next Big Thing: Collaborating in Research, Design, and Development to Create the Future of Healthcare,”by speaker Brian Mullen, Innovation Strategy Manager, Brigham Innovation Hub, Brigham and Women’s Hospital
Everyone has been to the “free-donut brainstorming meetings,” Adam Montandon begins. “9,000 Post-it Notes on a white board and nothing gets done…and you all do it again next year.”
Montandon, co-founder of the Factory of Imagination, advocates for students and professionals to learn by doing: a “do-ocracy” he calls it. The Factory of Imagination is Montandon doing do-ocracy. Here—beginning in an old and abandoned factory—he created a space for people to “get their ideas out of their head and into reality.” With a do-ocracy, he explains, you take ownership over your idea by doing it.
“Packaging is done brilliantly by engineers. …People are looking for something fantastic and unique and novel. People don’t just pay with money, they pay with attention.”
— Adam Montandon, co-founder, Factory of Imagination
Montandon is keynote presenter at sustainable packaging conference SustPack 2017 (Apr. 24-26; Scottsdale, AZ). Expert in product design and innovation at the University of Southern Denmark, Montandon has devoted his career to understanding the thought processes people go through to create new ideas; and, how these processes can be altered to create products and services that delight.
What is the business case for doing things in a fantastic way, he ponders?
The Factory of Imagination began with Montandon’s proposition to his students: I’m going to make the best lesson in the world, need some help, meet me after class. 150 volunteers later, the idea of one of Montandon’s students—Factory co-founder Steffie Limère—was brought to reality.
Some of the people working with the Factory of Imagination are recognized at the event.
The FOI put on its first event, inspired in part by Tomorrowland, a global music festival that celebrates community and fantasy. The event featured speakers ranging from robotics to memory to space. Montandon—a TEDx presenter and event organizer—used his network of innovators and thinkers to create an event which, unlike structured TEDx talks, encouraged speakers to “tell the stories that they have always wanted to tell; the best lessons.”
The event was huge. The event was exciting. The event was fantastic. And then the Factory was dismantled, to be rebuilt again in a new venue with new ideas.
“How inspiring it becomes,” Montandon reflects. “The Factory is driven by passion not profit; we don’t even give students grades. And businesses love it. They want to get involved and do workshops. ‘Can we have your students because they love the creative process,’ they ask? We develop workshops that help people figure out the joy of creativity, of thinking outside of the box.”
Today, the FOI takes many forms, including educational and training programs, workshops and events. A full-time FOI “secret laboratory” is opening at the University of Southern Denmark. Regardless of its form, all FOI efforts work to implement the imagination first.
“Packaging is done brilliantly by engineers,” Montandon states, “but the magic of products is in imagination. You can change an entire product line by changing the way people think. People are looking for something fantastic and unique and novel. People don’t just pay with money, they pay with attention.”
“A little nonsense now and then is relished by the wisest men,” (Montandon on children’s author and storyteller Roald Dahl).
Attend SustPack 2017 in Scottsdale to witness Montandon’s keynote, which promises to be a whimsical testament to the power of the imagination. It is with imagination that sustainable packaging goes from idea to reality. Let’s do sustainable packaging together.
Chandler Slavin is the sustainability coordinator and marketing manager at custom thermoforming company Dordan Manufacturing. Privately held and family owned and operated since 1962, Dordan is an engineering-based designer and manufacturer of plastic clamshells, blisters, trays and thermoformed components. Follow Slavin on Twitter @DordanMfg.
Endangered Species Chocolates’ debut into pouches enlarges the iconic animals to boost on-shelf attention while exploring a new look for the brand.
Endangered Species Chocolate, Indianapolis, has extended its territory beyond chocolate bars into flexible packaging through two new wryly named product lines: Barks, which are chocolates bagged in their bare natural state, and Bites, which are individually wrapped and bagged.
As with previous ESC products, the chocolates increase awareness of a variety of at-risk species such as the rhino and include conservation statistics. The products also help fund wildlife protection programs though ESC’s GiveBack program that donates 10% of net profits annually to partnering conservation organizations; current partners include the Rainforest Trust and Wildlife Conservation Network.
“What consumers want right now is a trust-worthy snack that is familiar, and fits into their demanding life-styles,” says Whitney Bembenick, ESC’s director of innovation. “Our new product lines hit every chord, from flavor to function. Made with real, premium ingredients and packed ready for any adventure, these snacks are a daily indulgence consumers can feel good about.”
ESC’s only previous non-bar products were cardstock “pouches” and glass jars of cocoa spread. Besides the new format, the matte-finish, resealable gusseted bags also present an updated look and an atypical color scheme distinguishing ESC’s first venture into flexible packaging.
Credited for the Bark and Bites packaging design is Nicholas Lee, ESC’s creative director, who responds to our questions.
What were the major design goals?
Lee: We wanted to stand out on shelf and put our GiveBack mission first. Watching packaging trends and visiting store shelves you see product displayed with light backgrounds and bold vibrant colors. To stand out among our competitors we used the one thing our consumers identify us with…the animal. Bold photography of beautiful species helps the brand stand out among others.
How does this design both continue and diverge from the brand’s legacy?
Lee: This design continues using the animal as our unique brand identifier. However, these offer a greater emphasis on the animal and now makes them the focal point of the package. Our 3oz bar labels have always had darker backgrounds. The new white background, brightly colored accents and updated fonts are a bold leap that explores a new look for the brand.
What elements are included or added vs. previous packaging?
Lee: We carry our 10% GiveBack statement, animals, certifications and cocoa content on all ESC products. The new packaging uses different fonts, species information on the back and larger, bolder animal photography. This is also the first time we have included product images.
What can be said about the individually wrapped Bites?
Lee: The individually wrapped bites now have a matte finish. We needed the look and feel to match the premium chocolate inside. We also love the play on the name “Chocolate Bites.” These snacks are a daily indulgence you can feel good about.
What was the most difficult decision?
Lee: The largest challenge was making the decision to give the animal such a large presence on the front of the package.
Barks and Bites are Fairtrade International certified, Non-GMO Project Verified, vegan (select products) and gluten-free. The packs are sold on Amazon.com and in Kroger and natural food stores across the U.S. at a suggested price of $4.99.
It was a “Eureka!” moment for me when three separate thoughts formed into one new idea about flexible packaging and a possible path in its sustainable future.
Three separate thoughts
1. Flexible packaging recyclability is hot. End-of-life scenarios for flexible packaging have recently focused on its recyclability, which is a challenge because of the complexity of many structures. But we are seeing huge improvement in this area.
At the March 2017 annual meeting of the Flexible Packaging Assn., Jeff Wooster, global sustainability director at The Dow Chemical Co., gave an update on where the industry is at right now, with news of many current projects.
Once such project is a collaboration to improve the technology needed to sort flexible packaging at Materials Recovery Facilities (MRFs) using the existing recycling collection infrastructure. A workplan and baseline testing in 2016 saw encouraging results and identified end-use opportunities for collected material.
The project was implemented by RRS (Resource Recycling Systems), coordinated by the American Chemistry Council, sponsored by Dow, Nestlé, P&G, PepsiCo, SC Johnson, Sealed Air and Amcor, and with input from the Flexible Packaging Assn. (FPA), the Assn. of Plastic Recyclers (APR) and SPI: The Plastics Industry Assn.
Scale up of the pilot plan is underway. According to Wooster, the key takeaway is “Adding flexible packaging sortation to an existing single-stream MRF is a small incremental cost.”
2. Demand for recycled content fuels material recycling. In some markets, recycled-content demand has been integral to growing an economically viable business for recycling that specific material—polyethylene terephthalate (PET) beverage bottles, for example.
But I can’t remember seeing any flexible packaging innovations that include recycled content as a key component (if do you, please comment below). At the same FPA meeting, 19 packages were recognized in the 2017 Flexible Packaging Achievement Awards and none of them talked about recycled content.
3. Using recycled-content in packaging is an important goal for many brand owners, which is why we included a section on this topic in the Packaging Digest 2017 Sustainable Packaging Study (take the survey now!). Early results show the majority of respondents (69% as of Mon., Mar. 27) say “Yes” when asked, “Does your sustainable packaging strategy include using recycled-content materials in your packages?”
One new idea
These three thoughts led me to ask “Is there a market for recycled-content materials in flexible packaging?” I started my quest for answers with a conversation with Wooster at the FPA meeting, and continue it here with input from others in the flexible packaging supply chain.
From the brand owner’s perspective, we hear from Kelly Murosky, packaging engineer at Seventh Generation, a company that makes sustainability a priority. It launched a recyclable pouch for dishwasher detergent pods in 2016, for example (see photo above), and recently improved the recyclability of its cartons for fabric softener sheets.
From the recycler’s perspective, we have insights from Susan Robinson, director, public affairs, for Waste Management, the leading provider of comprehensive waste management services in North America, including recycling services. Robinson will be speaking at the upcoming SustPack 2017 conference (Apr. 24-26; Scottsdale, AZ) on “Building Trust in Recycling.”
And from the flexible packaging manufacturer’s perspective, Sal Pellingra, vp of innovation and technology, ProAmpac, tells me the company has been there, done that (developed films with PCR content)—but with limited market success so far.
Here’s what these experts have to say about recycled-content flexible packaging.
Is there a market for post-consumer recycled (PCR) materials in flexible packaging? Why or why not?
Murosky: There is a market for post-consumer recycled (PCR) materials in flexible packaging because consumers are looking to brand owners to improve packaging sustainability, and brands are responding by reducing their use of virgin petroleum in packaging and increasing their use of PCR films. As flexible films continue to gain popularity, the market for PCR flexible films will continue to expand as well.
Robinson: Flexible packaging covers a range of products—from simple film bags to much more complex laminated “pouches”—like the zipper pouches used for many food products. Flexible packaging used for food-grade products has specific requirements for post-consumer resin (PCR), which makes it more expensive to use.
Furthermore, one of the benefits of flexible packaging is that it is designed with qualities specific to a product, which means that the resin type and laminates are varied. As a result, the cost of using PCR, the unique characteristics of the packaging and the small volumes involved have not led to use of PCR post-consumer resin in flexible packaging.
Pellingra: I believe there is a market just as there is for recyclable flexible packaging. In fact, it seems it’s almost more appropriate to use PCR than to produce recyclable flexible packaging because there isn’t an infrastructure for collecting recyclable flexible packaging unless the packaging uses the How2Recycle label program for in-store recycling.
There does seem to be some reluctance in the market to use PCR, however. It seems as if CPGs [consumer packaged goods companies] aren’t clear on the correct message to consumers or if using PCR matters to consumers. Because it’s difficult to produce an entire flexible package out of PCR, the message would be that a portion of the package uses PCR. Is that enough to warrant a change in graphics on an already cluttered graphic?
My personal feeling is that it is a step in the right direction, just as working towards recyclable packaging is—even before a recycling infrastructure is in place.
Will a demand for recycled-content materials in flexible packaging spur more flexible packaging recycling like it has in other areas of packaging (PET bottles, for example)?
Murosky: We hope it does, especially with the How2Recycle logo creating awareness among consumers that these types of packaging can be recycled with store drop-off plastic bags and films.
Robinson: Using post-consumer resin in products of all types (not just flexible packaging) is important to grow a sustainable recycling industry in the U.S. PCR use is more conducive in some materials than others—such as carpet. However, some companies have made a commitment to using PCR in their products, such as for PET water and soda bottles.
Pellingra: Just as the move to recyclable flexible packaging where there is no current infrastructure outside of the in-store recycling program, many CPGs and store brands are moving toward recyclable packaging with the common belief of the “if you build it, it will come” mentality.
Using PCR in the same way is diverting plastics from landfills and begins building the expectation that recycled materials can and will be expected to be used in products suitably designed to incorporate these resins. It seems reasonable and responsible to move in this direction. We just need some leading brands to begin “pulling” this demand from suppliers as “pushing” it has not seemed to generate growth in using PCR for flexible packaging to date.
ProAmpac developed one of the first recyclable flexible films for stand up pouches in North America with the introduction of the No. 2 Pouch back in 2011. Many companies are now offering similar versions.
We have also developed coextruded films with up to 15% PCR incorporated for use in surface print, lamination or pouch applications.
What are some of the barriers to using recycled-content materials, specifically PCR, in new flexible packages?
Murosky: I see four hurdles:
1. Getting the proper moisture and/or oxygen barrier protection;
2. Poor aesthetics, such as film color, unwanted inclusions and print quality;
3. Converters being open to running it on their equipment;
4. Higher cost of the PCR resin.
Robinson: Perhaps the greatest barrier to using PCR is the relatively low cost of virgin resin. With the low cost and sufficient volumes of virgin resin, it is generally less expensive to use virgin resin in products than PCR.
In addition to the barriers to using post-consumer resin in manufacturing flexible packaging, recycling flexible packaging is also problematic. Plastic film generally cannot be recycled at Material Recovery Facilities (MRFs) since our equipment is not designed to capture it and there are few-to-no markets for post-consumer MRF film.
The American Chemistry Councils’ WRAP program offers an excellent alternative to curbside recycling through its “Take Back to Retail” program; however, plastic film is not compatible with curbside recycling programs.
Pellingra: There are definitely controls required to ensure that the incoming PCR resin properties are consistent. This is the biggest challenge. It’s critical to ensure the properties are consistent, and especially that carbon and gels are minimized. Any of these can affect extrusion efficiencies.
In addition, every heat history can further degrade polymers and contribute to undesirable yellowing, gels or carbon that can cause visual defects and downtime. There is a science to minimizing degradation and securing quality supply of PCR resin. Not knowing where the supply is coming from, or the traceability of the resin, can cause some manufacturing issues. Because of this, the PCR is usually incorporated into the internal layers of film or into non-specialized products such as waste and non-food bags to minimize the impact. With additives and process controls, PCR is available as an additive in film products.
Have you considered incorporating recycled-content material into your flexible packages?
Murosky: We currently use a PCR sealant layer in some of our flexible film applications. Presently, we have 25% PCR content in our baby wipes film packages.
As we look to reduce our waste impacts, we are in the process of changing many of our barrier flexible film applications to a 100% recyclable solution. Also, to meet our 2020 packaging sustainability goals of zero waste and zero virgin petroleum usage, we are diligently working to increase PCR content in all of our film packaging applications.
From these answers, it seems promising that recycled content in flexible packaging will become a consideration for sustainability-minded brand owners—just as flexible packaging recycling will continue grow as an infrastructure builds.
When it comes to big dollars, product damage claims have the potential to rise to the top of a lot of internal reports and executive dashboards—especially if you’re shipping via complex and/or multi-touch methods.
While everyone wants to ship their products to arrive unscathed and with zero defects, there’s a lot behind the “science of packaging optimization.” Whether your incident rate is a high percentage of total volume shipped or a high dollar amount based on the value of the product, these damages touch multiple facets of an organization and often gain visibility at a high level, including up to the C-suite.
The additional cost factors associated with damaged products and goods
These claim dollars can really add up. But they are just the tip of the iceberg in terms of the total impact to your company’s bottom line, which includes “soft costs” like your brand image and customer satisfaction:
1. Rework and repairs: When the product shows up at the customer location damaged—or needs to be fixed, adjusted or repaired—this cost may include sending a technician to a job site, or to a customer’s location.
2. Return shipments: Assuming your product arrives non-functional, or your customer has elected to reject it due to the damages, you’ll have to pay for a return shipment just to get the damaged product back to your reclamation or repair facility, introducing reverse logistics issues and costs.
3. Expedited logistics: Oftentimes, consumers buy products because they need them quickly (go figure!). In some cases, they need the products to arrive at a certain date and time. If your product shows up damaged you may be on the hook to pay for an expedited shipment to replace your original defective product.
4. Interruptions and delays: Likewise, if you need a part or product to arrive and it shows up damaged, this may cause additional interruptions…machine down time, sending workers, installers, or technicians home. These delays waste time, and we all know that time is money.
5. Customer satisfaction/dissatisfaction: This is a no brainer because nobody wants unhappy customers. This laundry list of damage issues above only adds to customers’ dissatisfaction. (As many of us know, ordering a package to be delivered triggers your dopamine stimulation… there’s a real deflating feeling to have that product arrive dented, damaged or broken.)
6. Discounts and markdowns: Sometimes in lieu of returning the product you can offer customers a discount:
- Discounts or markdowns can occur at the retail store –the old scratch and dent sale
- These types of discounts erode at your profits and margins.
7. Sustainability: All those return shipments burn up precious diesel fuel and emit carbon dioxide, not to mention the extra garbage and waste created and energy consumed by having to scrap your product. Even though damages and claims are not often tracked as a sustainability metric, they definitely carry an impact.
As you can see, the cascading, multifaceted effect of damages can add up to impact your bottom line. What really helps is to clearly understand the supply chain hazards that impact products’ successful transit and addressing the hidden costs of damage—each of which impacts a company and customers in different ways.
So when your executive team is talking to you about those high damage claims, make sure you’re not just skimming the surface of the ocean ahead, but are thinking about the size of the seemingly small iceberg ahead!
Rob Kaszubowski is Sr. Packaging Consultant at Chainalytics’ Packaging Optimization where he is focused on reducing product damage and implementing packaging cost reduction initiatives. Rob also contributes to the Packaging Matters blog. Connect with Rob on LinkedIn and on Twitter @KazPack1