Driving Quality With Compliance

Certainty? “In this world nothing is certain but death and taxes.” If Benjamin Franklin was updating his famous quote for today, he might add a third item to his well known list: government regulations. It seems that no industry is immune, and given the global economy we all live and operate within, neither is any country.


Certainty? “In this world nothing is certain but death and taxes.” If Benjamin Franklin was updating his famous quote for today, he might add a third item to his well known list: government regulations. It seems that no industry is immune, and given the global economy we all live and operate within, neither is any country. Therefore, the issue for engineers is how to address these regulations effectively and easily, such that productivity does not suffer, and with the lowest total cost of implementation.

It is within this capacity that a well integrated software application can pay a handsome return by automating data collection tasks while alerting users should a potential non-conformance event be detected. Typically, regulatory compliance, though dealt with, ranks low in importance compared to other corporate initiatives. After all, how often has a government or regulatory compliance initiative been seen as a top strategic program necessary to make the year’s budget?

Therein lies both the challenge and the opportunity.

Taking a holistic view of compliance, one could argue that this process consists of three steps, each of which is shared with best practices of achieving—and continuing to improve—exceptional quality:

  1. Collecting the right data;

  2. Performing the appropriate business processes and validating their completion; and,

  3. Filing the necessary paperwork and reporting to demonstrate compliance.

Given the high internal visibility and need for performing at the highest quality standards, it is hard to imagine a global manufacturer today that isn’t acutely aware of what its quality performance metrics are, as well as how they fare compared to the competition. And, if you are outsourcing some of your operations offshore, multiply that concern by another factor, based on the fact that it is hard enough to manage quality within just your own organization, and nearly impossible when separated by an ocean.

Implementing a system for regulatory compliance or quality improvement invariably involves breaking out of functional silos. While that brings temporary trauma, the long-term effects can be well worth the pain.

Implementing a system for regulatory compliance or quality improvement invariably involves breaking out of functional silos. While that brings temporary trauma, the long-term effects can be well worth the pain.

Yet we must learn to operate and thrive within a highly distributed production and end user environment. For this reason, the quest for elevating quality and maintaining high levels must be automated if it is to be accomplished across disparate locations. Best-in-class manufacturers now recognize that the use of software to assist with this task makes a lot of sense, and has the return on investment to justify the decision.

As a result, the discussion should not be focused on what money do we waste to achieve the latest and greatest regulatory requirements (and what am I getting for this expenditure) but rather, how am I automating the implementation of a quality improvement program that will help margins, lower operational costs, and help position our products ahead of the competition. Such an approach makes the decision strategic, rather than tactical, elevating the results to drive new sales rather than create expense.

Fortunately, several viable options now exist to help consolidate distributed operations while providing necessary visibility and control to collect the right data, report on it, and contribute to continual improvement processes. The best systems will integrate seamlessly with your existing IT infrastructure, offering you a way to rationalize the myriad collection of sanctioned (and unsanctioned) applications that may exist across your organization.

The biggest challenge of selecting the right system is dealing with the fact that improving quality doesn’t fit well within the traditional silo approach to software purchases. It is relatively easy to purchase a word processing program: you want to write letters, reports, and articles, with an interface to your email system to distribute the files, so the scope is clearly defined and the effects are very localized. On the other hand, something that affects overall quality reaches throughout the enterprise, from the component parts purchased from various suppliers and where they are stored in inventory to the process of how they are assembled and distribution to ultimate end users. Implementing an overlay application that extends over many silos creates enormous challenges. Such is the case when it’s time to deploy a quality improvement program, which is probably one of the reasons why trying to improve product quality is such a challenge today.

Best practices for success

The best solution will be one designed for interoperability; one that is open to integration throughout your production, warehouse and maintenance operations. And, this solution must also extend into your supply chain network, providing the visibility to track quality metrics and even to reject shipments if your specified quality metrics are not achieved. Collaboration is the ultimate requirement of such a system, necessitating trust to be earned and shared across a highly diverse group of stakeholders.

One manufacturer that has recognized this benefit is Trixell, a joint venture between Thales (51%), Philips Medical Systems (24.5%) and Siemens Medical Solutions (24.5%). Trixell manufactures flat panel x-ray detectors, which are the equivalent of a digital camera for medical x-ray applications. The panel replaces photographic film and darkroom processes, providing a digital image that can be viewed, transmitted, and saved on a computer.

To maintain high manufacturing quality and documentation requirements for medical devices, Trixell needed a robust, dynamic manufacturing system capable of integrating operations seamlessly, while also conveying production data into its SAP ERP application, providing the corporate office with real-time visibility to production data.

One of the challenges Trixell faced was how to increase production and improve adaptability without impacting quality. Maintaining quality is critical, yet can be challenging due to the complexity of the production process, complying with medical regulatory requirements, high expectations of end users, as well as the length of time to build a complete digital radiology detector.

Extending existing infrastructure

Initially, it was believed that SAP ERP could be used for both quality management and execution; however, the increasing amount of data was not well suited for management within ERP. Instead, Trixell chose to implement an operations execution system (OES) offered by Apriso. It would function separately from ERP, yet be integrated so as to leverage the existing IT infrastructure.

As the OES supports multiple areas of operations—including their quality processes that span across their enterprise—the challenge of crossing functional silos was easily solved. Their quality program is managed through the ERP system, yet executed through the OES, resulting in a digital quality record of each device for internal use and regulatory audit.

The following processes show some of the collaboration now achieved across operations, helping to streamline and automate operations performance in real-time:

  • Production control: Each product has a unique digital manufacturing record, ensuring production stages are followed and details conform with SAP nomenclature.

  • Quality: Batch files created and uploaded to SAP; include the results of the tests performed, raw materials used, etc.; contributes to regulatory compliance initiatives.

  • Traceability of components and processes: An evaporation manufacturing process consists of depositing a chemical on the aluminum substrate, a process which must be tracked by batch of compound and by tools used to configure each detector.

  • Machine performance: Equipment specifications are captured and stored, including stops, breakdowns, maintenance actions and adjustments are all recorded.

  • After-sales repair and service: Future repair requests are evaluated against this data to best determine if part, or entire device, replacement is needed.

To meet regulatory requirements, extensive data collection is now automatically part of the production for each device and is stored for 10 years. Using an electronic format simplifies searching for data, which helps improve Trixell’s post-production processes. As occasional repair or warranty work is performed, problem diagnosis is facilitated with a digital 'as-built’ record by product, helping to provide enhanced customer satisfaction and lower support costs.

Given the certainty of government regulations and the need to comply, embracing this challenge with a solution to improve quality while achieving each of the required data collection, process monitoring, and reporting requirements makes a lot of sense and even helps demonstrate to your company the value that can be added from your project.

Author Information

Gordon Benzie oversees marketing for Apriso. Reach him at gordon.benzie@apriso.com .

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