The dangers of outdated documentation in manufacturing are very real, and so are the consequences. All it takes is a simple missing bolt to cause a catastrophic failure, leading to product recalls, safety hazards, or even death.
Recent high-profile incidents have illustrated the embarrassing, costly, and potentially deadly pitfalls of subpar documentation. The heightened scrutiny makes fallout more likely today if outdated documents are to blame for a mishap. The results range from job termination to prison time.
In 2024, many of the world’s largest manufacturers struggle with keeping documentation current, resulting in quality issues. The reasons include global supply chain complexities, advanced product designs, shorter product lifecycles, increased automation, regulatory pressures, labor shortages, and a growing skills gap.
When something goes wrong in a factory, work instructions are one of the first places investigators look. They want to see if workers followed the right steps. If they find the instructions were outdated, a world of hurt can follow.
Keeping documentation up to date is not just good practice; it’s critical to keeping people safe and products high-quality. There is simply no way to do this without a model-based approach that integrates real-time data from manufacturing systems.
The following are the disastrous results outdated documentation can cause with real-world examples:
Product Defects
Following outdated work instructions can lead to incorrect assembly and misaligned manufacturing processes. The oversight can result in defects that may not be immediately apparent, leading to defective and potentially dangerous products reaching the public.
Outdated documentation might fail to include new safety features, material changes, or updated assembly steps. When documentation fails to reflect changes in materials, design specifications, and production methods, the risk of product defects increases considerably.
Takata’s airbag recall serves as a prominent example of the dangers of outdated manufacturing documentation. Between 2013 and 2017, Takata produced airbags with defective inflators that could rupture upon deployment, sending metal fragments into the vehicle cabin. The issue was rooted in outdated manufacturing processes and quality control failures that were not properly reflected in working documentation.
The defective airbags were installed in millions of vehicles worldwide. They were deemed responsible for at least 16 deaths and more than 100 injuries. Takata went out of business due to the massive airbag recall, one of the largest and most complex in automotive history.
A model-based approach to manufacturing documentation helps reduce product defects by ensuring workers always have the most current information about product designs and specifications. When instructions are connected to live data from systems like PLM, MES, and ERP, any changes in the design are instantly reflected.
Safety Hazards
When manufacturing documentation is outdated, workers may unknowingly follow procedures that no longer align with current safety standards. The misalignment can result in equipment damage, injuries, and even fatalities.
As manufacturing processes evolve, so too do the safety measures required to protect frontline workers. Outdated documentation also leads to improper maintenance, incorrect use of equipment, and failure to adhere to new safety regulations.
The U.S. Chemical Safety and Hazard Investigation Board (CSB) reported a significant increase in chemical mishaps in late 2022 and early 2023, partly due to outdated or inadequate documentation and procedures. Cold weather exacerbated issues, leading to equipment failures from gear that wasn’t properly winterized.
California Manufacturing Technology Consulting (CMTC) details one instance where a worker was maimed due to outdated safety manuals. The worker’s arm was caught in a printing press because the documentation did not reflect newer safety standards that required additional machine guarding measures.
Shifting to model-based documentation connected to a real-time single source of truth ensures workers follow the latest safety protocols. If a new safety rule is added or an existing one updated, the work instructions are automatically updated. Keeping workers updated on the most current safety guidelines helps them avoid dangerous mistakes and stay safe on the job.
Operational Inefficiencies
Factory workers relying on obsolete documentation can stretch production times, increase costs, and reduce overall productivity. The inefficiencies can cause significant delays, financial losses, and irreparable brand damage.
In 2014, outdated documentation led to a massive recall of nearly 30 million vehicles for General Motors. For over a decade, GM produced vehicles with defective ignition switches that could unexpectedly shut the engine down, disabling safety features like airbags.
The issue caused at least 124 deaths and 275 injuries before it was uncovered. GM settled for $900 million with the U.S. Department of Justice to avoid criminal prosecution. The automaker paid an additional $600 million to a compensation fund for the victims’ families.
Infusing documentation with real-time data ensures every task is performed correctly and at the right time. When instructions are automatically updated with the latest information, workers don’t waste time figuring out what to do or redoing tasks. The streamlined processes ensure production stays on schedule, minimize product delays, and ensure resources are allocated effectively.
Equipment Damage
Using outdated work instructions can lead to improper use or maintenance of expensive machinery. When manufacturing equipment isn’t maintained or used according to the most current procedures, the risks of wear and tear, malfunction, or complete failure increase significantly.
The Piper Alpha oil platform disaster of 1988 is one of the most tragic examples of how outdated maintenance instructions can lead to catastrophic equipment failure. The oil platform, located in the North Sea, was plagued by poor documentation and communication regarding the status of safety equipment.
Documentation failed to properly record and communicate that a critical safety valve had been removed for maintenance. A series of miscommunications ensued among crew members. When there was a gas leak, the platform’s safety systems were unable to contain it. The leak caused a massive explosion that engulfed the platform in flames and killed 167 workers.
Model-based work instructions are key to keeping maintenance and operational instructions current in the Industry 4.0 era. When digital documentation is connected to systems that monitor equipment conditions, the instructions can alert workers to potential problems before they cause a breakdown. The approach ensures maintenance is performed at the right time and that machines are operated correctly, reducing the risk of costly equipment failures.
Regulatory Non-Compliance
When outdated manufacturing documentation leads to non-compliance with updated regulations, it exposes the company to fines, legal action, and even shutdowns. Local, state, federal, and international organizations regularly update their standards to reflect new safety, environmental, and quality requirements. Companies that fail to keep up with evolving standards risk severe financial and operational consequences.
The pharmaceutical industry, for example, has strict rules that companies must follow, known as Good Manufacturing Practices (GMP). In 2013, for example, Ranbaxy Laboratories faced severe consequences when an FDA inspection revealed that the company used outdated and non-compliant manufacturing procedures at its India facility.
The procedures led to contaminated and substandard drugs that posed significant risks to public health. The FDA’s findings resulted in a $500 million fine from the DOJ, a halt in production, and a consent decree that required the major pharmaceutical company to overhaul its manufacturing processes. Ranbaxy was effectively absorbed by Sun Pharmaceutical Industries after the fallout and no longer operates as an independent company.
Model-based documentation using real-time data helps prevent regulatory non-compliance by ensuring all procedures meet the latest industry and legal standards. When those change, the updates are automatically reflected in the documentation so workers always follow the correct procedures.
Conclusion
These are just some of the severe consequences that outdated manufacturing documentation can cause. As manufacturing evolves, modernizing documentation to incorporate real-time data from systems like PLM, MES, and ERP will only become more essential.
