You work in a regulated environment (automotive, medical, aerospace). New relevant standards are introduced on a regular basis. Existing standards are updated. Working methods constantly need to be adapted.

Does all of this really make sense? Doesn’t it just consume time with little benefit? Is it still possible to develop efficient, high-quality, and innovative products in such an environment?

We are convinced: Yes, it is!

Most standards in regulated environments focus on quality and safety. This applies to Automotive SPICE® and ISO 26262 in the automotive sector just as much as to IEC 62304, ISO 13485, or FDA requirements in medical technology.

Efficiency is not addressed in any of these standards and is therefore not assessed during audits or assessments. In other words: Good results in a compliance audit confirm good quality or safety — but these results may come at a very high cost due to inefficient processes.

The good news is: All standards allow flexibility in implementation. But this flexibility has to be used effectively.

Many standards focus on systematic development and development processes. Defining processes that are both compliant and efficient — and implementing them effectively in tools — is something that comes with experience. Especially from learning how others have successfully approached it.

Besides processes, many other aspects influence efficiency: 

• Strategy and alignment
• Leadership and decision-making
• Company culture
• Organizational structure and areas of responsibility
• Cross-functional collaboration and interfaces
• Management of interfaces with suppliers and partners
• Resource and capacity management
• Knowledge and competency development
• Employees: How efficiently do they work? How well organized are they?
• Tool landscape and digital collaboration environment

For processes and all of these aspects, we have developed a questionnaire-based assessment to identify opportunities for improving efficiency.

Here are a few examples:

• Strategy and Alignment
  • How clearly defined is the product and technology strategy?
  • How clearly are the goals for a development project defined?
• Leadership and Decision-making
  • Are clear responsibilities defined? Who decides what?
  • How well balanced are fast decisions and decision quality?
• Company Culture
  • What is the company’s error culture like (learning-oriented or blame-oriented)?
• Cross-functional Collaboration and Interfaces
  • How well are the different disciplines (e.g. systems, software, hardware, mechanics, project management, quality management) integrated and aligned?
• Processes
  • Which process step consumes the most effort?
  • Which tools are missing to enable more efficient work?
  • Where do errors typically occur?
  • Are there redundancies?
  • Is there potential for re-use?
• Knowledge and Competency Development
  • How well and efficiently does onboarding work?
• Tool Landscape and Digital Collaboration Environment
  • Who is responsible for the tools?
  • Is there a future roadmap or improvement plan?

Many of these questions are subjective. That is why it is important to interview employees from different roles and organizational levels.

As a result of the analysis, we create an anonymized report outlining the identified improvement potentials together with recommendations that serve as a basis for decision-making in improvement programs.

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• Performance of efficiency analysis, also as part of an improvement program

You are interested in our services? 

Use our Contact Form or feel free to contact us via:

Phone: +49 9194 3719957 
E-Mail: ​office@processfellows.de