Packaging, Labeling and Artwork Management


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Packaging, Labeling and Artwork Management

  1. 1. Integrating Packaging, Labeling and Artwork Management with Supply Chain May 23, 2012 | VEDANT BÖRSE | SAP PLM / PPM / SUSTAINABILITY ADVISOR | HCL AXON | White Paper plamPackaging Labeling & Artwork Management Specifications plam
  2. 2. P a g e | 2 In the era of competitive business, every company strives to reduce time to market, deliver quick product mix, and quickly change products to market needs. Packaging, Labeling and Artwork development processes are under constant pressure to deliver an increasing number of projects in an increasingly compressed time frame. Life Sciences and CPG companies on the other hand are governed by FDA validation, stringent quality norms and GMP. Errors can be costly, damaging and even putting company on stake due to recalls or FDA warning, fines. Packaging specification, package engineering and development team lacks coordination, resulting in longer Packaging design to Final Product development cycle, thus inhibiting the organization to quickly bring products to the market, eventually impacting its growth. Package copy, labeling and Artwork, on the other hand, play an important compliance role in communicating usage instructions, ingredients, drug facts, safety and efficacy data and patient information. A small mistake in the labeling copy or registration process, and the products could be subjected to FDA fines or even recalled. Contents Business Drivers.............................3 Industry Challenges....................4 Automation Nightmare .............6 Solution Approach......................8 Integrated Packaging & Labeling.......................................11 Looking Forward........................13 About Author..................................14
  3. 3. P a g e | 3 Business Drivers The key Business drivers that govern the whole Packaging and Artwork Management Process are; However in order to meet these demands, organization needs to examine the complete product development chain, the processes and the technology it relies on. Unfortunately even the most matured organization with best practices relies on applications which are narrowly-focused expert tools or homegrown applications, which delivers some localized benefits. Furthermore these applications are no longer supported by software vendors or prone to frequent breakdown leading the company towards security venerability. To make the situation worse these application works in silos and do not communicate with different processes resulting in Redundant and Repeat process. And companies whose entire business revolves around packaging and labeling needs to ensure that they don’t make any error. One error can damage company’s image due to recalls or FDA warning, fines and also result in loss of revenue. Organization should thus look for collaboration across various business units and build visibility across entire process chain so that they can reduce time to market and also reduce the compliance risk. • FDA compliance • Time to Market • Collaboration across operating units • Visibility across process chain
  4. 4. P a g e | 4 Industry Challenges Packaging, Labeling and Artwork Creation Process is under continuous pressure due to growing number of products, Sales Promotion or re-launch of existing products, shorter time to market, changing compliance requirement, and integration with multiple units.Thus the challenges with these packaging processes are abundant. Packaging, Labeling and Artwork management involves collaboration with various internal and external units.This includes o Product Development o Package Engineering and Configuration o Regulatory Affairs and Labeling Management o Artwork Management and Vendor Collaboration o Change Control o Packaging Product Manufacturing Interacting with so many departments and external agencies possess its own challenges. Disintegrated Formulation, Specs, Packaging, Labeling, Artwork, SKU and also Sales, Accounting & Operations results in; o Long Packaging BOM to SKU cycle o Redundant and Repeat process o Lack of visibility across the chain o Lack of coordination leads to inventory obsolescence o Lack of consistent metrics / analytical / error reporting o Errors, FDA warning, recalls
  5. 5. P a g e | 5 Packaging and Artwork development process on one hand is under pressure to deliver quick changes to product shape, design, labels and artwork in an very shorter time frame, on the other hand, Life Science and CPG Industries are governed by FDA validation, stringent quality norms and Regulatory compliance. Regulatory guideline by agencies like FDA, MHRA, etc. demand compliance within packaging, labeling and artwork processes to safeguard product consumer safety. Keeping up with these changing compliance requirements in different countries is a challenge. The upcoming (2014 and nutrition labeling in 2016) Regulation (EU) no. 1169/2011 on the provision of food information to consumers, is focused primarily on labeling. Some of the key regulation includes; o U.S. FDA 21 CFR Part 11: Electronic Records Electronic Signatures o Clause 11.10(e): Maintains electronic records (an audit trail) for revision and change control o EU Directive 91/356 (EU GMP Guideline): Document management and storage o Health and Safety Regulations Apart from lacking coordination between different business units and issues due to Regulatory compliance, some of the other challenges that are encountered in Packaging, Labeling and Artwork include; o Lack of integrated Package & Product Renovation process o Redundant specs/ recipes/ Labels/ Artworks/ Packaging Configuration o Weak version control and change Management o Validation challenges of BOM for effective Label Specification o Validation challenges against the right Artwork version o No central repository of Regulatory Specifications, Artworks, Sketches, master boards, etc. o No integration to other PLM related systems o No tool to govern & facilitate detailed PLM tasks and handoffs o Difficulty in Sourcing Compliant product o Validate against the inventory
  6. 6. P a g e | 6 Automation Nightmare In order to address the Challenges, companies build a solution, which on paper is the best designed solution. IT Landscape of Major LS and CPG companies is build around the philosophy that R&D, Packaging, Artwork processes are unique processes and needs niche software that works dedicated for these processes. It has all the spices that perfectly meet all the specification demanded by the business. However, the reality is that it’s a nightmare for business folks to use, and a big headache for IT to manage and maintain it. It is either a home grown solution tailored to fit, which could be a legacy application living its last breath and could break any day, and put the business at stakes or it could be a amalgamation of some the best of bread solution interwoven is such a way that only few of the Techies in IT team knows how to maintain them. Enguinity, Schawk’s BLUE, Maximo, Trackwise, Oracle, SAP, Sharepoint, Hyperion, Mircosoft office, you name it and they are patched up to build a best of breed solution bouquet. With so many software in place comes with its own sets of problem. Some are integrated, some are broken and some needs manual copy paste of data, resulting in risk of making some serious mistakes. And once these pieces start falling apart, companies spend millions of dollars asking consulting companies to evaluate what tools are good for them, when they already have SAP or Oracle ERP at their home capable of handling it. What’s rather required is a little bit of innovative thinking on top of it. Many Companies take pride of building these complex webs of software. And companies which are heavily dependent on Packaging process for their products or niche private label companies has a common reason to these meshes of software. “We are unique…”, “We are different…”. “Our processes are proprietary; it cannot be used by any other company”. And finally, even after having so many software, they build a large pool of so- called master data team, whose primary job is to just copy data from one system to another. Being a consultant
  7. 7. P a g e | 7 to these companies and an outsider, I have seen that 80-90% of the processes of these companies are same. Some has their own best practices and some don’t, or do it a little differently. Some of key Issues and Challenges these companies’ faces due to multiple software are; So what does executive wish…. Executives wish to have a highly complaint system with flexibility to adopt quick changes and speed up the process. They want a globally unified regulatory process which also meets region regulatory compliance, like FDA or MHRA guidelines. They want a globally scalable solution while ensuring that the systems are complaint to local needs. They want to reduce time to market but at the same time want to build flexible packaging derivatives. And finally want a single unified process, providing visibility to entire chain and at the same time want an ERP centric packaging and labeling solution. o Host of Legacy application with Disintegrated Formulation, Specs, Packaging, Labeling, Artwork, SKU and change control process and also Sales, Accounting & Operations to support management o Disintegrate Supply Chain to Product development and Packaging Systems o No single tool to administer & facilitate detailed tasks and handoffs o No consolidated reporting capabilities o Non-integrated/inconsistent, manual post launch tracking & analysis
  8. 8. P a g e | 8 Solution Approach So how do we do it? First of all, we need to understand that Technology is not the answer for all problems; nor is the Process Improvement, the solution to a problem. Rather process improvement complimented by technology is the right answer. The first process starts with building a streamlined process flow with appropriate stage-gates and a seamless hand-off between each process steps. Majority of the issues in Packaging and Artwork processes are due to lack of proper standard operating procedure and process guidelines. Companies should build Configurable Packaging that brings flexibility to build many derivatives of the packages. Many companies create one unique packaging BOM for each individual product. Situation turns worse, when individual Packaging BOMs are created for Promotion Packs and Displays configurations. Rather a combination sets of Primary, Secondary and Tertiary packaging can enables a company to build any many products as possible for different formulas, region, regulation, brands, and companies. Building Scalable and flexible processes that can be deployed globally should be the mantra.
  9. 9. P a g e | 9 Artwork processes on the other hand are still managed by manual process. An artist receives instructions in email, creates drawings in Mac computers and then finally stores them locally. Entire drawing design process becomes artist dependent rather than process dependent. Increased outsourcing of Artwork to subcontractors adds to further compliance risk and issues due to mistakes in Artwork communication. In the entire process, it has further been observed that overall review and approval process time is increased significantly. However at a closer look, we realize that Artwork Management is nothing but a combination of good Project Management, Repository Management, Version and Label regulatory control and actual Artwork authoring process. Except authoring Artwork, all other processes can be managed in ERP software like SAP or Oracle. These softwares are capable of Artwork Task management, maintaining Central Artwork repository, accessible over web anywhere, Version control, Access control, extensive Search option across all artwork data and content inside artwork, Audit Log and workflow. Similar innovative approaches can be adopted to manage product at its inception stage at recipe management to Label Specification, Regulations to all the way to supply chain. During my years of journey in consulting industry, I was able to define an integrated Process, which could enable the organization to create multiple product derivative with minimal BOMs, Manage Artwork Management, enable the Regulatory labeling specification guidelines linked to Artwork and manage the entire lifecycle of Packaging configuration request to Artwork to final SKU development built. Visibility is essential for sales to know which packing is saleable, for engineering & product team to see at what stage are the packaging NPD or Change requests. So a good reporting view should be built for visibility across process chain
  10. 10. P a g e | 10 Packaging, Labeling and Artwork process should be further complimented by automation software to speed up the development process. While selecting the software, companies should look for few integrated softwares that meets the business required, rather that pick all best of breed software. Explore the potential of existing ERP system within the organization. SAP or Oracle ERP have many modules with hidden potential for Packaging configuration, Labeling and Artwork Management. Effective use of software would reduce IT nightmares and allow Product Managers to spend more time in building better product and spend less time coordinate task between each departments. Some of the Key Ideas include; o Build integrated Process o Mature Change control and workflow approval process o Intelligent lifecycle report o Automation to pull compliant data for final assembly o Portfolio based project execution for NPI project initiation and Regulation change
  11. 11. P a g e | 11 Integrated Packaging & Labeling Over years, I have worked with various Life Science and Consumer Products companies to build an Integrated Packaging and Labeling framework that would enable organization to integrate their R&D recipes to Manufacturing Supply Chain. iGPL (Integrated Global Packaging and Labeling) is an end-to-end SAP-based solution framework that improves the Packaging, Labeling and Artwork management processes and reduces the time to market by improving operations efficiencies from packaging initiation through manufacturing. This solution framework manages packaging development and change management, enables adherence to the stringent FDA norms, manage increasingly complex packaging development procedure in the Life Sciences and CPG sector. Through the implementation of iGPL, organizations can realize greater and more rapid returns on their investment during the Packaging, Labeling and Artwork design, development, and change phase. The application framwork, designed for SAP PLM, includes capabilities for o Packaging Initiation o Packaging Specification o Package Engineering and Configuration o Regulatory Affairs and Labeling Management o Artwork Management andVendor Collaboration o Packaging Product Manufacturing Integrated Global Packaging and Labeling Solution has been designed considering global regulatory norms, Industry best practices, GMP and Business processes derived from various shop floors. The framework
  12. 12. P a g e | 12 integrates various aspects of packaging including Specs Management, Packaging Configuration, RA controlled Labeling Specifications, Artwork Task and workflow Management, SKU and Change control process. iGPL is suitable for organization managing packaging solution in different legacy applicable and is planning to build an integrated process around SAP from Recipe Development to packaging initiation to the final shop floor manufacturing process for the packaged product. This framework has enabled organization to achieve the following benefits; Time to Market Visibility Automation Sustainable Design Regulatory Change Management Integrate the whole supply chain from Packaging initiation to SKU End-to-end Lifecycle reporting Integrated semi-automated solution Foundational System for Future Enhancements (such as Quality Inspections and Gated Development with Portfolios for NPDI) CFR 21 complaint framework integrating Artwork to label Specs and packaging configuration Stringent but Quick Change process for Product conversions
  13. 13. P a g e | 13 Looking Forward Packaging, Labeling and Artwork Process is critical for Product development. An eye-catching and distinctive packaging gets consumer attention and increases sale. Therefore the importance of packaging process cannot be underestimated. At the same time the process needs to be robust enough to meet all product compliance and reduce time to market. Companions should thus build an integrated Process chain with a continuously improved closed loop process system. Build a stage gate process for entire product development processes with unique phases and checklist for Packaging, Labeling and Artwork steps. Break the paradigm and culture of departments working in silos. While Government regulations are continuously becoming increasingly stringent, with the advent of social media, any mistakes in artwork are increasing being published by social media user, thus sending invitations to FDA, MHRA to increasingly knock the doors of companies for their violation. Companies should thus increase product safety and traceability on a continuous basis. Artwork and Labeling processes are not rocket science that needs unique software. They are processes that were somewhat neglected by ERP software vendors but still have capabilities in its existing PLM module, though they may not be specifically called as Artwork Module or Packaging Modules. Avoid building a mountain of so called best of breed softwares. PLM and ERP vendors have started increasing their focus on Packaging, Labeling and Artwork processes and have initiated building dedicated software modules integrated within the ERP suites. So look for current offering and future roadmap of ERP vendors like SAP and Oracle in the area of Packaging, Labeling and Artwork. And finally, remove the misconception that your labeling and artwork process is unique. There are many companies managing their packaging, Labeling and Artwork processes with the ERP based PLM solutions in a very flexible and innovative way. Companies planning to build a robust Packaging, Labeling and Artwork Process should; o Build an Integrated and closed loop procedure for Packaging, Labeling and Artwork while continuously improving and updating the processes o Establish Standard Operating Procedures and governance process in Product development processes o Setup appropriate Packaging infrastructure and software solution to ease adherence to compliance o Build knowledgebase repository of Artwork to avoid rework and repetitive mistakes. o Build early warning system and regulatory compliance visibility report from product development to end of life stage o Integrate Packaging, Labeling and Artwork process with R&D and Supply Chain
  14. 14. P a g e | 14 About Author Vedant Borse is an International PLM Professional with 18 years of Industry experience working with Big 5, SEI CMM L5 firms in various Leadership capacities as Engagement Manager, Enterprise Solution Architect and Functional Consultant. Mr. Borse has delivered product development strategies (organization, global footprint, cost management, processes, metrics), best practice methodologies, enabling technology solutions, and change management programs to help improve company's product development operation. He has developed PLM Roadmap for organization and helped organizations in defining Enterprise Architecture for Life Science, FMCG, Oil & Gas, Hi- tech, Automotive and E&C companies. His work involves understanding and selling solutions (ROI) for high level business problems, incorporating all PLM and SCM solutions. Mr. Borse is a Business process design and Modeling, Benefits realization and Value engineering expert. He is a professional expert in various SAP PLM modules including PLM 7.0, PPM 6.0 (RPM, cProjects, cfolder), PS, DMS, ECM, CAD Interface, Recipe Development, Specifications Management, EHSM 3.0, SPRC 2.0 and BusinessObjects PCM 10.0. His SAP experience includes 14 End-to-End SAP Implementations (with Solution Manager) and 2 ECC 6.0 Upgrade, working as Project Manager and Functional Consultant on various modules. Deep experience in management of projects, solution choices, lead of team, quality processes, deployment in heterogeneous environment, ability to develop strong customer relationships in industry, author documents for projects, studies or proposals. To his credit, he has developed an Integrated Global Packaging and Labeling Solution (iGPL), enabling organization to condense time to market cycle and integrate the entire Packaging to SKU cycle. He has also authored papers on Future Product Costing and Product Regulatory Compliance. Mr. Borse has been a regular speaker in SAP Conference and had also been faculty for SAP PLM Training to train SAP customer and SAP employees at SAP Labs on SAP PLM and PPM. Raleigh, North Carolina, USA The information contained in this White Paper has been obtained from various sources that I believe to be reliable. The document reflects my judgment at the time and is subject to change without notice. The trademarks and registered trademarks of the corporations mentioned in this publication are the property of their respective holders. Copyright 2014, Vedant Borse