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ISO 13485:2016, when implemented by industry-specific specialists, provides for continued improvement, emphasizing defect prevention, and the reduction of variation and waste in the total supply chain while improving the financials. That is why generic ISO 13485:2003 is hurting your business, prescribing an overabundance of lengthy generic procedures and generic auditors; hence, the new industry-specific ISO 13485:2016.

One of the most notable benefits original equipment manufacturers (OEMs), plastics processors, and precision tool makers offer is that they start and lead the product manufacturing process, showing the biggest trends in the industry. They offer a glimpse into what companies, big and small, are investing in, and more importantly, what they consider to be the top needs of manufactures – from the CEO to the workers on the plant floor and everyone in between. High performance and clarity of operations strategy are a common pairing because it is operational processes and functions that OEMs, plastics, and precision tooling companies deliver to customers.

In the past, organizations implemented management systems to meet the requirements of applicable international standards due to customer or marketplace pressures. They were viewed as an additional cost to the business rather than actually providing a platform for finding opportunities for process, product, and service improvements.

With the issuance of the 2016 revisions to ISO 13485 and ISO 14001:2015, organizations are required to demonstrate measurable performance improvement. By proper use of the management system requirements, organizations can achieve sustainable business success. The sustained success of an organization is the result of its ability to achieve and maintain its objectives in the long term. The achievement of sustained success for OEMs, plastics processors, and precision tooling companies is a complex and demanding challenge as they operate in an ever-changing environment.

This series of articles, ISO 13485, is a guide for how companies have used the management system requirements of ISO 13485 and ISO 14001 to realize cost savings.

ISO 13485:2016 improves the financials by asking: How much does quality cost? Most companies would be hard-pressed to translate quality into real dollars and cents. What they do realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

We need to understand OEMs, plastics processors, and precision tooling organizational elements are aligned, or else different parts of our operation will head in different directions. Fundamentally speaking organizational elements are:

  • Processes
  • Sourcing approach
  • Infrastructure
  • People

However, processes come first because the purpose of operations is to deliver a service or product to customers, which requires the right processes. If we don’t understand the processes we want, then it’s hard to choose suppliers, build infrastructure, or select people that consistently deliver. The highest level of a process is a value stream. We need to know our value streams as they are today, what we want them to look like in the future, and the gaps we need to fill – a value steam map for each department.

Measure current processes

Unavoidably, value stream clarity means we need to have competencies in measurement. Simply put, without measurement we are in the dark, and few operational leaders really enjoy that experience. This means that the first step after mapping your current processes is to measure them. This is often the starting point for a genuinely advanced operation. The measures must address effectiveness (or the extent we are meeting customer needs to a defined level of quality), efficiency (how much it is costing us to do so), and sustainability (the extent to which we are burning out our people or infrastructure). No assessment of today is complete without at least a point-in-time assessment of performance; later we will want to try to make that continuous and in real-time.

If we know our current processes and our quantified performance, we can now be clear on what our future processes will look like and targets for how they will perform. The next step is to decide the core: what we will do ourselves as opposed to outsource. In these decisions we are first assessing what we can do better than anyone else at a given level of cost, or what gives us a unique competitive advantage.

When we know what our future processes look like, what our measurable targets are, and which pieces we will do ourselves (as opposed to outsource), then we have real clarity of operations strategy. Now we have a platform on which to make decisions about people and systems because we understand what we want to do, and which pieces we will be delivering ourselves. Only at this point can we feel confident about all the workforce is on the same page.

Waste elimination

The fastest way to improve performance is waste elimination, but first you have to find the waste and prioritize. I recommend that organizations do two important things:

  • Collect data on specific value streams in order to reduce waste
  • Develop the infrastructure and means to measure on an ongoing basis.

It is important to focus on the first of these two imperatives.

A value stream is the high level of activities that are conducted, generally sequentially, to provide a customer with an outcome. For example, product research, design, marketing, sales, fulfillment/installation, and servicing. Processes tend to be practically defined as specific parts of a value stream, for example the product development process or the sales process.

CEO/owners needs to know in detail when to use data collection methods. And, they should assure themselves that they have access to competent personnel who can use the right approach. These days, the journey need not be a long one (given the development of modern tools and techniques), but there is still no alternative to good information being the basis of good decision making. That goes as much for waste elimination as any other leadership consideration. Otherwise, it is exceptionally difficult to emerge from the fog of loose information and hearsay.

About the author: Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. He can be reached at 706.694.2977 or lewis.yasenchak@windstream.net .