The breakneck speed of technology change, fluctuations in supply chain costs, and ever-greater competition on a global scale mean that today’s manufacturing executives now more than ever rely on foresight on industry trends for opportunities to reduce overhead and squeak out greater ROI on the shop floor.
Like a 16th century explorer taking to the high seas, risking it all to discover a quicker route to deliver in-demand raw materials from suppliers in the East to markets in Europe, the manufacturing C-suite seeks an advantage. Greater efficiencies and more effective processes on the shop floor translate directly to the continued solvency and profitability of your organization.
Years ago, when I was a manufacturing manager with medical device maker Danaher, I found that adapting to changes on the shop floor is a situational imperative and a critical part of production. There are specific goals executives and managers are trying to hit each year, but the overarching objective is to continuously improve product quality and the experience of the customer.
A key method manufacturing leaders use to keep operations tight is lean, the systematic school of thought for waste minimization in manufacturing processes that doesn’t sacrifice productivity. Based largely on the Toyota Production System, lean techniques can help manufacturers achieve gains through the reduction of non-value-added activities and costs.1
Five primary concepts comprise the leading principles typically associated with 1990’s “The Machine That Changed the World”2:
Based on a 2017 case study of Johnson Controls, a global electronic and HVAC component manufacturer, the comparative benefits of implementing lean production measures can be a game-changer.3 As a result of implementing lean production practices, the company experienced:
A manufacturer can reap significant benefits from lean practices, including waste reduction and increasing value-added production by upgrading equipment, training employees and implementing more efficient processes.
Yet for all the benefit that lean offers manufacturers, a lean program can only be as efficient and valuable as a company’s data management system. A manufacturer that relies on a manual paper-based or hybrid document manage is prone to systemic errors and delays stemming from incomplete, missing or unstructured documents. For the life sciences or similarly regulated manufacturing, that translates into inefficient batch record processes, data tracking that can result in shipment delays, product quality issues and incompatible systems.
But manufacturers still must keep track of the batch paperwork, which necessitates extra time for operators to manually write deviations or nonconformances or physically walking a traveler to a shop floor computer to enter production information. In short, the product is complete but can’t be shipped because the paperwork is incomplete.
Contrast that with a fully digital, software-based document management system for your data, documentation, signatures and communications that breaks down silos, drives efficiencies and improves levels of quality and control. Along the same lines, an electronic batch record (EBR) gives a manufacturer the ability for real-time batch record form validation, quality reporting and corrective action potential.
Manufacturers that pair an automated and integrated document control system with a lean production program can eliminate greater amounts of waste and experience much higher levels of quality than they otherwise could with the limitations of a paper-based system.
But despite all the investment and effort required on the lean journey, it’s surprising how many companies stop short of the end goal by failing to make the digital transformation.
I identified the following key lean principles through which a manufacturer’s operational effectiveness can be significantly amplified when processed in a digital documentation system:
1. Eliminating waste: Where many manufacturers still depend on paper-based systems to manually track critical production information, implementing lean measures remains problematic, time consuming and costly.
For example, if you’re seeking to reduce the number of steps required by an operator to access a part needed in production or the time it takes to access a tool, employees must track down the correct paperwork and production records. A manufacturer can eliminate a much greater amount of waste by capturing production information digitally in real time with a system that automatically verifies accuracy and completeness of documents. The data is stored and readily available from a single access point for analysis and decision-making by stakeholders and managers.
2. Just in Time (JIT): A form of lean production and a logistics method of inventory control.4 It’s a system of customer-based manufacturing on demand: what the customer wants, in the quantity the customer wants and when she wants it. The reduction or elimination of buffers or inventory is possible with JIT, and allows the use of delivered components within minutes of their arrival.
However, a manual data system means that data is difficult to track and verify with the result being that product ends up sitting on the shipping dock awaiting the correct documentation rather than on its way to customers. Automation allows a manufacturer to review batches in minutes instead of weeks while simultaneously decreasing the amount of carried inventory to maintain short lead times and more on-time deliveries.
3. Poka-yoke: A Japanese term that means to dummy proof your processes so that neither a production operator (nor a customer) will make a mistake. This data can include a range of critical information, including equipment calibration dates, tolerance measures, pass-fail qualification, etc.
Using an electronic data capture ensures that operators follow the correct SOPs and processes every time. A digital solution can also confirm that operators are trained and qualified to upload product data into the system.
4. Kanban: Another Japanese word that conveys that idea of using signs or cards to indicate where in the production process a product currently is, i.e., pre-production, in process and complete. This technique helps manufacturing managers and line supervisors to only pull those parts or materials needed in a specific run or batch of product. This contributes to less waste and excess inventory.
Through digital production record software integrated into operations systems on the shop floor, batch records that include materials, parts and production quotas are carefully managed in real time so that products are not overproduced. This reduces costly errors that can easily result with paper-based systems because all the data and production records are connected and accessible from a single point of entry. Digital data systems allow a manufacturer to enhance the principle of Kanban by limiting waste and errors than impair compliance.
In summary, lean manufacturing principles can only get a manufacturing organization using a legacy data system — or a battered trading tall ship in need of refitting — so far. To fully maximize the benefits of lean that can lead to greater ROI, manufacturers will need to invest in the digital transformation and take active steps not only to upgrade to an automated data solution, but also introduce a companywide culture where everyone contributes to improving quality and reducing waste.
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