Meeting Regulatory Compliance and Improving Manufacturing Throughput by Avoiding Pharmaceutical Package Coding Errors
Heidi Vanheerswynghels, Strategic Account Manager EMEA – Pharmaceutical Market, Videojet Technologies
There may be no other industry in the world where accurate package coding is as critical as it is in the pharmaceutical industry. The consequences of shipping a mislabelled product can in the worst case be life-threatening to the patient and even in the best case they can expose the pharmaceutical manufacturer to potential regulatory action. In recent years, a number of patients have died after apparently taking medications that were incorrectly labelled1.
In nearly all cases, mislabelling errors are detected and corrected before shipment, but even these cases may result in substantial expenses due to lost production and the need for rework to correct the labelling errors.
The challenge of avoiding coding errors
The challenge of avoiding coding errors is particularly great because the pharmaceutical industry is currently in the process of overhauling its packaging processes in order to comply with regulations around the world that are requiring the printing of serialised information on primary, secondary and tertiary packaging. On January 1, 2015, the first phase of the US Food and Drug Administration’s (FDA) 2013 Drug Supply Chain Security Act (DSCSA) took effect that mandates the development of a national unique product serialisation system capable of tracking all pharmaceutical products at every stage along the entire supply chain. Over the next eight years, drug manufacturers, wholesale drug distributors, repackaging companies and pharmacies will be required to develop, test and implement such a system. As new product identification systems are implemented to comply with these regulations, the highest possible level of attention needs to be paid to product coding accuracy. At the same time, coding solutions must deliver legibility and contrast while facilitating line productivity and seamless integration in order to succeed in today’s competitive environment.
Videojet recently surveyed consumer goods manufacturers to get a better understanding of package coding errors. About 40% of the companies surveyed experienced coding errors at least once per week and about 25% had coding errors every day. The most common causes of coding errors according to survey respondents were incorrect data entry and incorrect job selection, accounting for a total of 45% of all coding errors. The first reaction of most pharmaceutical manufacturers to the discovery of coding errors is generally to institute additional checks following the coding operations. However, when coding errors are discovered after the fact they nearly always result in significant losses such as lost line time producing the bad packages as well as the need for costly manual rework.
Getting coding right the first time
Substantial cost savings can be achieved by avoiding printing the wrong codes on packages in the first place. This approach is often called by the Japanese term Poka-yoke (pronounced “Poh-kah-yoh-keh”) which can be translated as mistake-proofing. When applied to manufacturing operations, a Poka-yoke is any measure put into place during the manufacturing process to prevent human errors before they occur. The right printing partner can help a pharmaceutical manufacturer design a comprehensive system that implements Poka-yoke principles through advances in printing technology to eliminate coding and marking errors. Of course, even if you are effectively preventing coding errors you still need the ability to quickly detect errors that somehow occur in spite of your efforts so that you can take action as quickly as possible to correct the error.
The Videojet approach
Code Assurance is Videojet’s comprehensive approach to preventing or eliminating errors in the coding and marking process. We believe that human-machine interfaces – including both hardware and software components – can and should be designed to simplify data entry and help prevent operator errors, both at code entry and job selection. We firmly believe the structural flow of coding processes can be redesigned to remove operator interactions and reduce the risk of errors, even to the point where automatic distribution of correct codes to the correct printers for the correct jobs becomes the norm.
Our approach begins with making it very easy for the operator to select the right message for the job. For example, the printer’s user interface can include features such as separate user authorisation for code creation and job selection, restricted and pre-approved coding parameters, and job storage under intuitive names that speak directly to the product being coded. Second, we suggest limiting operator input to essential information only. For example, a handheld scanner can be linked to the coder to enable quick and precise message selection and accurate code loading during product changeovers.
Messages can be automated with pre-defined rules that help avoid errors. Predefined coding rules can automate much of the message creation process, minimising day-to-day operator input while ensuring that any necessary input complies with policies and logic that pertain to the specific job. Finally, coding data should be pulled from authoritative data sources such as a manufacturing execution system (MES) or enterprise resource planning (ERP) system to help ensure that the right information is loaded into the printer. Multiple coders can be connected together using common software through a company network and an internet or Ethernet connection.
Getting the right code on the right package every time requires constant vigilance. The consequences of marking the wrong code on a pharmaceutical product can be dramatic: costly rework, regulatory fines, recalls and even consumer illness. Choosing a coding partner with the ability to expertly manage the creation and loading of codes can reduce these risks.
About the Author:
Heidi Vanheerswynghels is a Strategic Account Manager at Videojet Technologies. She leads a defined group of the company’s global pharmaceutical key accounts and carries responsibility for all medical and pharmaceutical business in EMEA. Taking a central role in sales growth, Heidi works also closely with the Videojet marketing team to develop and implement campaigns, collecting and analysing market data to support product development. Heidi has more than ten years of management experience in the medical and pharmaceutical packaging industry; prior to Videojet she was a Key Account Manager at Vitalo Packaging. She is fluent in Dutch, English, French and German and has a basic knowledge of Italian.
Videojet Technologies is a world-leader in the product identification market, providing in-line printing, coding and marking products, application specific fluids and product life cycle services. Our goal is to partner with our customers in the consumer packaged goods, pharmaceutical and industrial goods industries to improve their productivity, to protect and grow their brands, and to stay ahead of industry trends and regulations. With our customer application experts and technology leadership in continuous inkjet (CIJ), thermal inkjet (TIJ), laser marking, thermal transfer overprinting (TTO), case coding and labelling, and wide array printing, Videojet has more than 325,000 printers installed worldwide. Our customers rely on Videojet products to print on over ten billion products daily. Customer sales, application, service and training support is provided by direct operations with over 3,000 team members in 26 countries worldwide. In addition, Videojet’s global distribution network includes more than 400 distributors and OEMs, serving 135 countries.