Monday, 24 March 2014


In all likelihood, your company has already encountered difficulties harmonizing quality management systems (QMS) with product life cycle management (PLM) systems. Synergies between engineering, manufacturing, supply chain management, and service will not materialize on their own—even in a closed-loop QMS. Part one of this three-part series describes how integrating the QMS and PLM can improve quality management processes throughout the enterprise.

Leveraging PLM integration to strengthen your business case

If you can make a strong business case to justify the investment in new QMS capabilities, executives are more likely to buy in. Specifically, PLM and QMS integration is one aspect that you can use to strengthen your business case and win buy-in from top business decision makers.

Closed-loop quality management begins at the highest levels of your organization. Without buy-in from key stakeholders, your quality management initiatives will fall short of your expectations. In a worst-case scenario, cost of quality may actually increase as the result of poor leadership and error-prone software implementation.

Of all the enablers of closed-loop quality management, winning buy-in from executives is arguably the most critical. You must be able to make the case to your organization’s leadership hierarchy by highlighting specific synergies and potential improvements over current benchmarks.

PLM and QMS integration improves FMEA and CAPA collaboration

Integrating PLM with the QMS offers several advantages for engineering-intensive companies, including:
  • Improved communication among engineering, manufacturing, and post-production monitoring
  • Designing for quality from conception to post-market analysis
  • Facilitating more efficient corrective and preventative actions (CAPA) based on PLM integration
  • Automating the workflow of failure modes and effects analysis (FMEA)

In the past, manual processes have impeded the efficiency of identifying and correcting nonconformances from a value-chain perspective. Automated FMEA processes and PLM-based CAPA can enable faster cross-functional collaboration than ever before.

Synergies become more visible when functions outside the engineering domain are able to collaborate faster with harmonized QMS with PLM systems. Given the intensity of competitive pressures, silos of information are no longer acceptable in today’s global manufacturing industry; best-in-class organizations have already realized the cost savings of QMS integration with PLM and other business management systems.

Where to begin: Cross-functional collaboration in action

After winning buy-in from the top business-decision makers in your organization, the next most important step is evaluating and benchmarking current PLM capabilities. To achieve the best results, you should look to develop a cross-functional team to conduct this critical analysis.

Traditionally, PLM systems have been widely used among engineering-intensive companies. The problem is that in a large, globally distributed organization, disparate PLM configurations can make integration very troublesome, even if your company anticipates quality issues well. From a cross-functional perspective, harmonizing PLM systems with a QMS gives your company the benefit of closed-loop FMEA and CAPA processes. Engineering data can no longer afford to remain idle in isolated silos of enterprise applications. PLM-to-QMS integration only increases the efficiency of mitigating quality management issues as early as possible during the design process.

In short, when you harmonize QMS and PLM systems, your company will be able to document tangible improvements in FMEA and CAPA QMS processes. To shed more light on a sound QMS implementation, part two of this series will cover how manufacturing operations management systems fit into the closed-loop QMS equation.

Sound quality management systems touch every level of your organization, from conception to post-market monitoring. Not surprisingly, manufacturing operations management (MOM) systems benefit from quality management system (QMS) integration. In an ideal scenario, closed-loop quality management principles can increase your company’s ability to respond to and mitigate quality issues early in the design process.

However, this situation is not always the case, which places the onus on MOM-to-QMS integration to catch quality issues before products reach the global market.

One of the key challenges of a manufacturing-intensive organization is how to improve collaboration among shop-floor operators and quality testing personnel. MOM systems provide companies with a means to efficiently bring products to market—and, most important, on time and at a lower cost.

Time is of the essence on the shop floor. Best-in-class organizations have already discovered how to harmonize their MOM systems with enterprise QMS. On the front lines of a bustling manufacturing environment, operators need immediate—if not real-time—access to any nonconformance notifications. Otherwise, poor-quality products may continue to be fabricated despite the immediate call to action.

Pinpointing the root causes of nonconformances is useful for preventing these lapses from occurring in the future. The problem is that a company’s critical data may reside in isolated, manual (i.e., paper-driven) quality management processes. Eliminating these manual processes with an automated QMS will only improve efficiency over the long run.

As touched on before, product life-cycle management (PLM) systems align closely with failure mode and effects analysis (FMEA) and corrective and preventive actions (CAPA). Including MOM systems in this QMS equation only creates further synergies throughout the enterprise.

MOM-to-QMS integration and quality management processes

As an effective method for preventing nonconformances from recurring on the shop floor, CAPA processes alongside MOM systems benefit from QMS integration, too. For manufacturing-intensive organizations, MOM integration is arguably the most important pain point. In an automated QMS, the advantages of harmonizing QMS with MOM systems surface in unforeseen ways.

Harmonizing QMS with MOM systems allows organizations to benchmark the cost of quality more effectively. Ideally, establishing a baseline of current capabilities will help improve cost of quality, but aside from cost benefits, MOM-to-QMS integration also helps improve statistical process control (SPC) and hazard analysis and critical control points (HACCP).

Specifically, by integrating and automating HACCP processes, an organization may actually improve compliance over time. Also, automated HACCP processes can help locate areas of weakness during production. As such, synergies with nonconformance/CAPA process become even more apparent.

Beyond QMS and MOM integration

MOM-to-QMS integration certainly has several benefits when automating traditionally manual quality management processes. Fine-tuning the synergies created by harmonizing QMS with MOM systems and PLM systems is the next step.

In the past, your organization may have experienced much difficulty eliminating manual quality management processes. The reasons for this difficulty are many, but essentially, they all boil down to the problems that disparate QMSs create. Harmonizing QMS and MOM systems enables your organization to rid itself of slow, error-prone manual CAPA and HACCP processes.

CAPA processes cross several different functions within a typical enterprise. Without utilizing a QMS as a hub of data exchange and collaboration, companies will likely achieve minimal results when optimizing manufacturing operations. To make closed-loop quality management a reality, companies must acknowledge that MOM systems benefit from QMS integration, too.

MOM systems and CAPA quality management processes go hand in hand. In a fully harmonized QMS, MOM systems touch PLM systems via increased data exchange and collaboration. To tie all QMS aspects in this series together, you need to include supply-chain management into your planning. Part three will address this.

Sources: LNS Research, Quality Digest, IQS.

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