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Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Process Documentation Strategy: Reducing Quality Risk in a Lean Company

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It is no surprise that many companies these days are trying to do more with less. In fact, the majority of the medical device companies that contact Novatek state that the reason for outsourcing is they don’t have expert resources of their own. While Novatek’s purpose is to make end users’ lives easier through documentation and training that improves usability and operational efficiency, this becomes even more critical when the end user is an employee in your company. As companies become leaner, accurate process documentation becomes critical to support cross-functional operations.

Reality and Risks in Lean Companies

Reality: In effort to save money, companies often…

  • unintentionally encourage each department to create their own system for managing quality by not setting a standard.
  • unintentionally utilize numerous segregated tracking tools by not investing in a company-wide tracking system.
  • use spreadsheets to keep track of CAPA requests and investigations.
  • ask employees unfamiliar with a system to write the Standard Operating Procedure (SOP).
  • train new employees on a process by providing a stack of SOPs to read.

Risk: Without a centralized quality management system and uniform process, companies are exposed to additional risks, such as:

Tracking progress and documents are difficult when using multiple systems. Verifying status or approval may require a number of steps or manually following a paper trail – a time consuming effort. Even worse, when a document gets lost, the effort to track it down is compounded.

  • Rework

When procedures are not documented correctly, errors occur. These mistakes often result in repeating the process again, wasting valuable resources and time.

  • Repeat errors

Without well-written and thorough SOPs, employees may continue to make errors in the process. It is easy for employees who are familiar with the system to overlook small steps in the process when writing the procedure or to make assumptions about the knowledge another employee has of the process.

  • Customer experience

The overall customer experience is negatively impacted when a system doesn’t integrate all departments or processes. Without the ability to see the full picture, it is nearly impossible to give customers complete and accurate information.  

  • Reputation

In today’s environment, a user can share a negative experience with the world in seconds. To avoid spending excessive time and money doing damage control, companies should focus on preventing quality issues from the get-go.

In order for a lean business to avoid these risks and thrive, quality and efficiency must be priorities. By improving process efficiencies and properly documenting procedures, errors and mistakes will be reduced, thus creating a better customer experience and avoiding unnecessary drains on company resources – a problem lean companies cannot afford.

To learn more about how to mitigate risk with SOPs…

Download our free guide:
A Guide to Standard Operating Procedures

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Topics: Process documentation, usability

 EU MDR