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

Standard Operating Procedures: Documenting Core Processes for Business Growth

workingProper process documentation is critical to managing risk. Last month, we discussed 4 ways to ensure that your standard operating procedures are used consistently. Now we’ll share some indications that your process documentation might need an update and how you can address these gaps.

8 Signs of Process Documentation Gaps

  1. ISO audit deficiencies
  2. Variations in product output, quality or completion time
  3. Missing or incomplete required paperwork and reports
  4. Injuries and other safety issues
  5. Employee complaints that process is not consistent
  6. Miscommunication or uncertainty of next steps due to unclear procedures or specifications
  7. ”Jumping the gun” – someone takes a premature step or skips a step
  8. Customer complaints and unmet expectations

In a manufacturing setting, these can be symptoms of process communication gaps. An FDA consent decree or product recall is a much more severe example, which can cost a company millions – even billions – in lost revenue, corrective action costs, market share costs, and hits to reputation and stock price.

Areas Where Documentation Can Help

Whether you’re facing a compliance issue or employee miscommunication, most companies can benefit from clear, concise process documentation. Common areas of need include:

  • Quality system procedures
  • Manufacturing process
  • R&D process
  • Reporting procedures (for medical device manufacturers, see Mandatory Reporting Requirements for Manufacturers, Importers and Device User Facilities to ensure compliance)
  • Internal audit process
  • External audit process
  • Nonconformance procedure — if a product doesn’t meet standards and specifications
  • CAPA procedure (Corrective Action Preventative Action)— to investigate root causes
  • Customer complaint handling procedure
  • Product recall procedure
  • Review & approval procedures for documentation
  • Verification procedure of software/product
  • Validation procedure of software/product
  • IT system procedures  for proper use

Your employees will rely on these process documents daily to perform and comply with proper design, development, manufacturing, testing and quality control of your products. Others documents are intended to prevent critical missteps in a “what if” scenario. By documenting and training employees on processes such as reacting to a product recall, your company can reduce financial risk and reputation damage.

Proper documentation also reduces another risk: institutional knowledge loss with turnover of key employees. Many manufacturing customers are facing workforce skill gaps and an aging workforce. Your master tradesmen are nearing retirement, but their knowledge and skill sets have not been sufficiently transferred to up-and-coming employees. Clear documentation can allow newer employees to successfully perform steps that were previously more of an art than a documented science. 

For a complete review of your processes, download our SOP Worksheet to start closing those gaps.Download

If you’d prefer a needs assessment, we’d be happy to help.

Topics: Process documentation, SOPs

 EU MDR