Global quality implementation

Q: My organization has grown by mergers and acquisitions, and now has multiple quality systems around the world. How would you approach creating one quality system for the entire organization? What quality tools should be used, and what concerns or roadblocks should be considered?

A: First of all, yes, it is generally considered a good idea to avoid maintaining multiple quality systems. Moving to one system reduces compliance risks, facilitates training and makes it easier for the organization to transfer manufacturing operations, if desired. There are many ways to do this wrong. This answer identifies a few of the project’s potential failure modes, and discusses causes and mitigations.

Prevent slow and inefficient implementation. At best, the project is likely to proceed slowly unless the right project-personnel infrastructure is in place at all levels of the organization. The project sponsor must be a representative of top management—the CEO, or at least someone on his or her staff. The quality system merger should be on the sponsor’s performance objectives and part of a strategic plan that is visible to the entire organization.

Under the sponsor, there should be a steering committee of high-level individuals representing key stakeholders in the organization—in terms of function and position. Representatives from quality, R&D and operations should be included to review and give the impression that the project is universally owned and supported. If the industry is regulated, an understanding of the relevant standards and certifications is of the utmost importance, so the regulatory compliance function should be represented at a high level in the project-personnel hierarchy.

The hands-on project leader or manager should be chosen carefully, and should be a dedicated resource with successful complex project management expertise and possibly lean Six Sigma training. The project leader position is too important to be given to someone as a stretch or developmental opportunity, unless there is close mentorship from a leader.

It’s preferable that the project is led by someone who has already demonstrated the ability to organize and communicate cross-functionally and globally. The project working team will be relatively large because of the scope and complexity of the project. Minimally, experts in all the quality-system elements should be identified to develop and own the new global processes. Site owners also should be identified to provide input and ultimately take the new system to their locations.

Prevent system problems and inefficiencies. In the worst case, a project plods through, and a bad system is implemented, which can happen easier than you might imagine. A sound and systematic process must be followed from the beginning of the project.

It is a best practice to fully characterize the current state by determining:

  • How many different quality systems or partial systems are in place.
  • Where they are used.
  • How well they are working.

You can determine the ideal future system by answering these questions: What quality system elements are desired or required by industry standards? What are the best practices of model organizations?

You also will want to benchmark by leveraging experience from employees who may have seen other good quality systems. To ensure the new system is fully functional, it is important to understand the inputs, outputs and interrelationships of all the quality-system processes. Consider doing a series of suppliers, inputs, process, outputs and customers diagrams, and put particular emphasis on those processes that have the most inputs and outputs. Consider using a relationship diagram with arrows to show connections between quality-system processes.

Roll out the new quality system all at once rather than in stages, but if that is not possible, sequence the rollout wisely. Document control seems like a good process to get in place early so all the subsequent processes can have the correct, standardized documentation format and content.

Another candidate for early implementation is risk management—an input to many other processes, such as design control, production and process control, and corrective and preventive action. Standardize risk-rating scales and acceptance criteria for consistency. Keep in mind that no process exists in isolation: That’s why it’s difficult to get around the need to implement all at once. Consider whether it’s possible to develop a parallel global system off-line, and go live with the entire system all at once.

Prevent a lack of acceptance. The system may not be welcomed by some employees, perhaps those who believed their local system was already the best in the organization.

Organizational change management is critical. The users of the system must be informed and represented throughout the project. Ensure you have a broad and well-documented final review of all procedures and forms before implementation to identify potential gaps and pitfalls. Track and respond to feedback.

You also must manage external auditors. Communicate your intentions with regulatory agencies and other auditors well ahead of time to avoid over-scrutiny and surprising them later.

Prevent confusion in the transition. A plan must be made to determine what to do with in-progress work when the new system is implemented, such as:

  • Partially completed new product development and improvement projects.
  • In-process, post-market work (complaints, nonconformances or corrective actions).

The new system should be mapped to all the former quality systems. This is so people know which procedures are replacing other procedures.

A well-planned training program also is essential. Consider allowing detailed, local work instructions to remain in place, at first, so higher-level procedures can be tested with minimal risk. When the organization is comfortable, roll out the next merged layer of work instructions.

Most importantly, communicate with transparency and clarity throughout the project to ensure trust and buy-in. You are disturbing employees’ workplace, and a project of this magnitude has many more opportunities to go wrong than right.

Scott A. Laman
Senior manager, quality engineering and risk management
Teleflex Inc.
Reading, PA

Nonconformance reporting

Q: A nonconformance report process is well established for manufacturing when most activities are repeatable and occurring in a well-organized, between-four-wall environment with the same personnel. How do you duplicate the same process efficiently in a project environment in which there is less repeatability, different locations and different personnel?

Jacques Vetil
Raleigh, NC

A: Many organizations have problems effectively and efficiently deploying processes. When multiple locations exist, personnel are different, and the frequency of observations for defects varies. This requires a thoughtful deployment. Let’s examine each of the important issues involved in more detail:

Multiple locations. This often means different cultures are involved. Multiple cultures may exist within a country, state, region, across countries or other geographical delineations. They also may exist due to organic growth, or more likely due to mergers and acquisitions over the years. Multiple cultures present an onerous deployment and should be a top consideration, regardless of how you proceed.

Different personnel. This can present an arduous problem with regard to:

  • Language—Multiple languages may be involved, and personnel may be required to speak a nonnative tongue.
  • Generational gaps—Today’s work environment is often multigenerational. As such, generational differences must be addressed, particularly with regard to training.
  • Turnover—If high turnover is a problem, the training, policies and procedures discussed later will become paramount.
  • Frequency of observation—If reporting of nonconformances is few and far between, it’s important that personnel have access to a process expert. Further, the use of cheat sheets is often helpful, and they may take the form of laminated placards or something similar.
  • Here are some key drivers in creating a successful process deployment—that is, in your case, the deployment of a nonconformance reporting process.
  • Management commitment—If this doesn’t exist, everything else is a moot point and failure is ensured. Don’t waste your time. Seek out a scapegoat and transfer the blame.
  • Plan the process—Develop a detailed deployment plan. This includes communications from senior management. It also minimizes the opportunity for things to go wrong.
  • Procedures and work instructions—These documents provide authorization to deploy the nonconformance reporting process. The level of detail included in these documents depends on the level of education of the personnel performing the process and the quality level of output that can be tolerated.
  • Training—Training may take many different forms. Furthermore, several forms of training may be required, such as classroom instruction or on-the-job training supported by existing personnel who know the process well. And don’t forget about the opportunity to pilot the process.
    Furthermore, make sure trainees understand how to recognize a nonconformance. This sounds trivial, but it’s often overlooked. Consequently, the results are disastrous.
  • Follow-up—This is a simple but essential step. Go back and ensure the process is performing as intended. If not, determine the root cause and make the appropriate adjustments. Many organizations deploy a process, never follow up and wonder what’s wrong.

These points will help stabilize the deployment and minimize the variation in the process outputs. There are additional drivers, but those I’ve our lined are critical for success. Good luck with your process deployment!

T. M. Kubiak
Performance Improvement Solutions
Fort Mohave, AZ


Kubiak, T. M., The Certified Six Sigma Master Black Belt Handbook, ASQ Quality Press, 2012.

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