Walking the high wire between innovation and compliance - Will PLM be your safety net?

How an integrated PLM approach can empower Food manufacturers to incorporate Safety and Compliance as a key process during the NPD cycle with DevEX®.

There is a precarious balancing act in play. You may think of it as a death-defying high-wire act, but the stakes are equally, if not much higher. Corporations must balance the demands of capturing the eye of consumers in a whirlwind of emerging trends: Functional Foods, Organic, Wellness, Probiotics and many others.

Not only must they determine which of these are truly trends and not the fast-dying fads, but they must do so will outpacing their competition to a global market. This global market presents its own distinct set of challenges-a frenzied maze of continually changing regulatory compliance issues for a gauntlet of government agencies around the world.

Adding to the complexity is the slippery slope of claims and the definitive nature of the compliance issues being established by government agencies. What once was a domain of marketing departments and advertising agencies has been taken over by legalities that are being strictly enforced. While some corporations play with wording and push the boundaries, many have found that the costs can be very high with stiff fines, recalls, and worse – the loss of consumer trust.

So, how do you walk the high wire act of innovation – both in the development of your new products, marketing them with the claims, and ensuring that your are complying with those claims? And, equally as important... how do you accomplish all of this ahead of your competition, within your budget to secure the success not only of the product itself, but of your corporation?

We can begin by looking at the processes themselves. The traditional lifecycle is a consecutive lifecycle with each stage occurring directly after the completion of the prior lifecycle. This sounds logical... but is it profitable? Is it strategical? We can begin by examining where the regulatory analysis typically (or in the traditional sense) begins... after the innovation is completed. Why? This simply does not make sense. There is a complete breakdown in collaboration, communication and integration across all departments in this sense. Essentially – everyone is stuck on their own disparate island of data and no one is talking to anyone else.

What is the result? Stagnancy. Redundancy. Blindness to an original vision. Initial concepts can be lost, safety requirements can be hidden, more trial and error will occur-all of this results in a longer lifecycle and mounting costs. Without a doubt, this traditional model will lead to a substantially higher risk of non-compliance.

But what would happen if there was a shift in the paradigm? How could a fundamental re-working of the entire thought process revitalize the entire lifecycle of a NPD? This is what we will explore and its direct impact on not only the innovation, but the actual compliance management.

The integrated PLM approach
The perils of the traditional approach have already been explored and understood. But would the impact be of overlapping the stages? What would happen if more than one stage occurred at a time? How would an integrated approach change the game?

How would we accomplish an integrated approach? It could not be with the traditional methods. We have already discovered their costly detriments. An integrated approach, requires an integrated solution. Something that takes the best of breed methodology and merged it with cutting-edge technology-a PLM solution.

Selerant's Product Lifecycle Management (PLM) solution, DevEX, is a web-based solution with a configurable core and add-on suites that integrate seamlessly with each other as well as with legacy systems. Why is this important? The legacy systems will provide the critical ERP data for the true costs of the project-including resources.

Now that we know what our defined integrated approach is, we can explore further what it can actually do. 

The PLM approach is a logical approach, but unlike the traditional method, it is a new logic. It takes the best practices and merges it with the technology. Similarly, it integrates the people that will be utilizing it as well and makes it a part of the solution.

Initial implementation
One of the most critical aspects of any PLM solution is the implementation. It is this point where the key decision-makers will sit down and decide exactly how the solution will interact with their business as a whole. How will this drive our lifecycle? How will this transform our collaboration? What practices will we now automate? What regulatory analysis will we need?  Some corporations can make these decisions after careful consideration, but as most PLM solutions are a healthy investment, it is most wise to invest in professional consultants who can guide you through the process to ensure the maximum ROI.

It is these initial, but crucial steps that will define future success.

Changing the game

As stated earlier, the PLM approach changes the methodology. What once was consecutive, now becomes overlapping. Where team members were isolated and focused on their singular tasks, they are now united-united with each other and with a central repository of data, essentially raising the efficacy of collaboration on every level. Greater visibility, transparency, traceability, and access eliminate constraints team members once had and truly spark innovation.

This can be best seen in the new product request with a specific claim. Where this once took several months, if not years from concept to launch, it can now take a matter of weeks to a few months.

Claims simplified
We will begin with product claim, resulting in a need to modify the product and see how it impacts the entire lifecycle (as well as how this can be significantly improved in PLM).

For this example, our marketing department has determined that they want to declare the product as Low Energy (which means under the EC directive 1924/2006 below 40 Kcal /100g).

A PLM solution will unite the disparate data to connect the dots across the collaborative teams-from marketing, to development, through validation and regulatory. In this example, marketing's request will be sent on to development where in PLM, they can elevate visibility of the request as the use the new requirements as a target for the recipes they are developing.

At a later stage, the Low Energy requirements should be validated, included in the labeling (as some PLM systems include near camera-ready art generated labels), and signed off by the legal and compliance department. Throughout each of these activities, team members should be able to collaborate effectively through version-controlled documents, accessible through an agile, single entry system that can be retrieved through a central data repository, eliminating duplications and costly errors.

We summarized the regulatory compliance side of this rather quickly. Being a substantial aspect of the NPD process, we will go through it in a little more detail:

Regulatory compliance – A sum made greater by its parts

An IT tool requires properly defined and maintained foundations (specifications data) to be automated effectively.

Ingredients – Managing ingredient data, classifications, compositions, and restrictions
Ingredients are the building blocks of recipes. Within each ingredient is a raw material with data specification. 

These specifications will specify if the ingredient has any: contaminants, allergens, nutrients (specific levels of each), if the ingredient passes certification for Kosher, Halal, Vegan, Organic, etc. This data provides invaluable insight not only to the total cost of your product-critical information for the overall health of your project, but to your regulatory analysis as well.

 As your legal department will tell you, what one government agency views as a harmless added ingredient another views as a hazardous substance that will find you in violation and non-compliant. How do you avoid a nuance from becoming a costly nuisance? The details do make the difference. The details of each raw material should be documented within your data system. (Some systems, such as DevEX, will provide a separate, user-definable form for vendors to enter that can be synched with your PLM database.)

Once you have a database of ingredient specifications, classifications, compositions, and restrictions-your PLM system can more efficiently run compliance analysis on each formula (as well as linear explosions of formulas within a formula). The more detailed your database, the more accurate (and effective) your analysis can be to ensure compliance for every recipe in every defined region in your global market.

Requirements – Defining, managing, and analyzing target market claims
If you define your product requirements BEFORE you begin, you will have a clear outline, or blueprint, for the success of your entire product lifecycle. But how do you clearly define such a detailed requirement?

Some PLM solutions, such as DevEX, deliver pre-defined templates to begin the process.  While a great starting point, corporations can further the process with personalized implementation consulting services to tailor the requirement to their specific products. 

Once a generic product requirement has been created, a team member can copy it and modify it for a more specific product requirement. This will include the specific certifications and claims for the product as well as exclusions, such as allergens and packaging. It will also include the regions where the product will be manufactured, distributed, and sold. These play an integral role for the automated analysis – where the PLM system can automatically analyze and alert developers if an ingredient has been added that is listed as a hazardous substance for one of the defined markets.

The up-front investment of meticulous product requirement definition has significant ROI with a dramatically reduced product innovation timeframe as the developers have elevated visibility to each defined detail and with automated analysis, can receive immediate insight into any compliance issues to ensure a smooth validation process.

Labeling – Generating multi-cultural, ingredient listing, nutritional labeling
Integration between the Formulation/Recipe Management and Regulatory suites plays a critical role in accurate labeling. This integration enables the data to be merged directly from the Recipe Management database to the standardized and user-defined layouts for label artwork that can be used for packaging. This direct integration/merge ensures accuracy as well as efficiency with no room for error.  Equally as important, corporations can have greater control over how words are displayed with user-defined tables for Alternate Names of ingredients in the Ingredient Listing for culturally sensitive ingredients.

Compliance rules – Managing, creating global changes, generating reports
Simplifying Compliance Management does not mean diluting its control. It actually is quite the opposite. Compliance Management plays a critical role in your product success, so you should have a definitive control over the analysis, its reporting, and automated alerts. 
Do you have an organized repository to check latest legislative information? Do you know which ingredient is allowed and which is banned in a certain country? Can you easily adapt to extend your business in new markets? Can you easily adapt your rules to support sets of requirements that may comes form a new customer? DevEX has a rule engine that supports all of that in a single and intuitive platform where data from different source such as data providers or authorities can be easily integrated.

Regulatory compliance and your daily operations

Managing product safety and compliance is not only about innovation and renovation; it is also about the daily operations, the supply chain, the Raw Materials variances, and the shelf life of your products. All of these variables and processes must also be a part of your PLM.  Successfully managing your regulatory data will ensure smoother NPD lifecycles that extend past the innovation and validation stages to the documentation and on to manufacturing.

How does a PLM Regulatory impact manufacturing? If you modify a recipe on the manufacturing floor, you can make the adjustments in DevEX according to the specific Raw Material's lot data, analyzing to ensure compliance and immediately generating documentation from a template, and version-controlling the recipe in the specifications.

The safety net
Everyone has an eye out right at this very moment. The competition is seeking out the next trend. Government agencies are searching for non-compliant products. Consumers are demanding for the next big thing. 

What are you looking for? If you are looking for a solution to your high-wire dilemma, DevEX will empower you to expedite your new products to market while ensuring compliance-to regulatory issues and claims.