Clarity on PLM

I had the chance to talk with … a couple of vendors this year about Quality Lifecycle Management, or QLM. I posted earlier about What I Learned: Expanding PLM’s Pervue – Quality and Risk Management and promised to follow up with some more detail on the vendors. Here are my thoughts on my conversations with MasterControl. Before I get started, it’s important to state up front that MasterControl is not a pureplay QLM suppplier, but a broader solutions company that has strong capabilities in document management coupled with a history of helping companies in regulated industries. More on that later.

What do they Do?

Industry analysts like to put software companies into categories and neat little boxes so we can compare them to each other. This doesn’t fit the reality of most software companies or solutions, because – with the exception of some very mature enterprise solutions or point tools – the solution scope and footprint varies from vendor to vendor.Quality management solutions are particularly difficult, because they are often part of a larger solution (such as ERP, PLM, MES, or a combination of the above). As one commenter on my last post rightfully points out, “quality is a series of well defined business processes.” 

So what box do we put MasterControl in? You could start with “Document Management” and cover a lot of bases. In fact, MasterControl does offer document management capabilities for quality processes, including FMEA, CAPA, non-conformance, quality audit, regulatory submissions, and others. But that would not really suffice in an explanation. MasterControl also helps to manage change control, and even position themselves as a “compliant PLM” solution in some instances. Indeed, they can manage BOMs and other engineering and manufacturing data, including the DMR (device master record) for medical device companies. 

What do they Offer?

So not quite so easy to fit MasterControl into a single box, but one thing is certain – they should be considered when companies are looking for QLM. So while they don’t fit neatly into that box, they have a lot of capabilities in that arena and more. MasterControl focuses more on process compliance than product compliance, which is different (and potentially complementary) to some other, highly product-focused QLM solutions. One other consideration that is pretty unique is that MasterControl also helps regulated companies validate their software implementations. They also offer an integrated training module which helps track employee training records, which can be important to compliance efforts and audits.

Who do they Work With?

MasterControl works with a large number of manufacturers in the regulated industries, but also serves less regulated industries. Their customer list spans quite a few industries, including both discrete and process manufacturing industries. They also have a strong presence in midsize companies.

So that’s what I hear from MasterControl, I hope you found it useful. I have talked about two very different vendors so far, which points out how fragmented this market really is. What do you think? Is quality a missing link in PLM? What else should I have asked them?

I had the chance to talk with … a couple of vendors this year about Quality Lifecycle Management, or QLM. I posted earlier about What I Learned: Expanding PLM’s Pervue – Quality and Risk Management and promised to follow up with some more detail on the vendors. Here are my thoughts on my conversations with Dyadem. One early caveat is that Dyadem – while they support the QLM approach to quality – refers to themselves as a “Quality Risk Management” solution provider as opposed to QLM.

What do they Do?

Dyadem has used the terms “Risk Lifecycle Management” in addition to “Quality Risk Management” and QLM to describe what they do. In my conversations with them, I have found they are very thoughtful about what they call their solution. What is common to the descriptions I have heard from them are the terms “risk” and “quality.” Why? Because risk and quality are intrinsically tied together. Poor quality management results in excess costs, a very hard metric to get a handle on. Poor quality also opens companies up to significant risks in the market – from poor customer perception, high repair/warranty/replacement costs, or from potentially catastrophic results of product failure leading to legal action.

So Dyadem helps companies reduce the cost and risk of poor quality. How? For one thing, Dyadem tries to help companies learn from their repeated errors. Many quality issues follow a pattern of:

• Create a condition that leads to an error
• Make an error
• Correct the error
• Repeat

What’s missing? Learning from the error, and changing the underlying condition that led to the problem. I know this doesn’t sound like rocket science, but it is probably the core element of QLM – and one that is dreadfully missing in most manufacturing companies today. Corrective action needs to be applied to the underlying condition as opposed to the error itself. This is what the quality “lifecycle” is all about – feeding the cause of errors back to engineering so they can be designed out of products and/or manufacturing processes.

What do they Offer?

In short, Dyadem offers solutions that help companies identify their errors and put in place quality and risk management processes. Identifying errors comes from analysis of manufacturing and quality data. By crunching the numbers coming from the underlying manufacturing systems (such as ERP) they can help identify recurring problems. In addition, Dyadem offers solutions to put in place quality lifecycle processes including:

• Failure Modes and Effects Analysis (FMEA) – to identify potential and recognized errors and put in place corrective action to prevent them, preferably early in the product design cycle
• Fault Tree Analysis – to identify potential hazards that can lead to an error
• Process Hazard Analysis – to identify risks or hazards based on processes and put in place prevention measures (an example of this technique is HAZOP)

A trained eye will also notice that most of these techniques are adopted to comply with regulatory mandates in certain industries, as clearly Dyadem helps companies comply with quality and risk management regulations in addition to helping them reduce the cost and risk associated with poor quality.

Who do they Work with?

Dyadem works with discrete manufacturers such as automotive, aerospace, and medical device companies as well as process manufacturers like pharmaceutical companies. In fact, Dyadem offers separate versions of their flagship Stature product for process and discrete as well as some industry flavors of their other solutions, such a their FMEA-Med tool which (not surprisingly) helps medical device companies develop failure modes and effects analysis documents, which are important for FDA validation.

So that’s what I hear from Dyadem, I hope you found it useful. What do you think? Is quality a missing link in PLM? What else should I have asked them?

I had the chance to talk with … both Dyadem and MasterControl earlier this year about their Quality Lifecycle Management (QLM) solutions. The conversations are examples of how PLM is expanding to cover additional product-related processes. Quality is among a number of product lifecycle processes - including compliance, service, product costing, direct sourcing and potentially others- that are logical extensions to PLM. QLM, however, is still a standalone solution for the most part. So what is QLM, and how does it fit into the product lifecycle and into product lifecycle management (PLM)?

Note: OK, this is really a combination of two 1:1 conversations, I wonder if that is a 2:1 or 2:2? So let’s call it a “What I Learned” and follow up with the Dyadem and MasterControl stories later this week.

What is Quality Lifecycle Management?

Quality is an important aspect of any product, and key to the profitability of a product across its lifecycle. Quality management plays critical roles in the product lifecycle, including:

• Accelerating time to market (particularly in regulated industries where products must be approved for sale)
• Ensuring and documenting compliance to industry or customer quality processes
• Improving customer satisfaction and response to customer complaints
• Reducing the cost of poor quality
• Minimizing corporate risk
  
• Applying lessons learned from product use to enhance product designs (closing the loop in the product lifecycle)

Quality lifecycle management includes managing the quality of the product as well as the quality of product-related processes. One quality lesson we have learned as an industry over the years is that managing quality in through inspection is not as effective as managing quality in by design and through good process. For that reason, managing quality processes is as important as managing results.

One example of a QLM process is managing product quality in design by correcting problems before they surface with approaches like Failure Mode and Effects Analysis (FMEA). FMEA (specifically design FMEA, or DFMEA) is a great example of where QLM can help because it can directly impact product quality, but can also impact time to market and compliance. FMEAs are mandated in certain industries and by some customers, and can delay product launch if not available (although hopefully we aren’t putting them together at the end of product development, but actually using them in the beginning). Corrective and Preventive Action (CAPA) is another example of a process that attempts to close the loop in the product lifecycle, by tying actual quality issues back to be addressed in earlier phases of the lifecycle (through another design revision or modified manufacturing plans, for example).

How does it Fit in the PLM Ecosytem?

There are a number of competing and complementary solutions that can help manage product and process quality. These include specialized Quality Management Systems (QMS) in addition to ERP, Product Lifecycle Management (PLM) and QLM. In the ideal scenario, I would place the majority of the quality planning functions in PLM, which probably requires a PLM/QLM hybrid. Then, the execution would be tracked in ERP/QMS and fed back into a QLM capability in PLM to close the loop. Unfortunately, most PLM systems do not have needed QLM capabilities, let alone a solution that can compete with standalone applications. To be fair, two PLM solutions that I know have invested in these capabilities Agile and Aras. QMS also plays an important role, typically adding strong analytics capabilities to monitor and improve product and process quality. Of course, QMS solutions are also a logical choice to provide QLM capabilities. In short, the landscape is full of good solutions to choose from, but it takes some work to sort it all out. For more on the expansion of PLM solutions into related processes, please see PLM, Please Take 3 Giant Steps Forward.

Implications for Manufacturers

Manufacturers today can’t afford the risk and cost associated with poor quality. In most industries, the base quality of products has improved pretty dramatically over the past decade. And for many industries (such as Medical Devices or Pharmaceutical) there are mandatory processes that must be complied with.  So managing quality is not optional, it is a cost of doing business. The area where I see an opportunity for manufacturers to gain an advantage of their competition, however, is to apply quality management concepts to the product lifecycle – closing the loop between product design and the rest of the lifecycle. This is where the opportunity for QLM really comes into play.

So that’s what I learned, I hope you found it interesting. What do you think? I will follow up with more from the vendors later this week.