Friday, June 30, 2017

ISO 9001:2015 Internal Audits

“Is the Process Approach to Audits Just a Myth?”


By: Andy Nichols

Since ISO 9001:2000, it’s become increasingly common to consider that an organization’s Internal Quality Audits be performed using the so-called “Process Approach.” At the time of publication, that particular version of the International Standard for Management Systems contained no description of what the process approach was. The recently introduced 2015 version makes the “Process Approach” a lot clearer by describing what is envisaged, in section 0.3 of the Introduction to the Standard–and how it applies to the quality management system–development, implementation and improvement. Reading further, the text goes on to describe the Process Approach involving the “systematic definition and management of processes, and their interactions, so as to achieve the intended results.” There’s no mention of anything to do with conducting internal audits in any particular fashion.

Perhaps the Internal Audit requirements, found in clause 9.2, will reveal something…

This particular clause states that “the organization shall:

a) Plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the process concerned, changes affecting the organization, and the results of previous audits;”

Interestingly, even this statement, which deals with the actual planning and implementation of the internal audits, doesn’t require that those audits shall (or even should) be conducted using the “process approach.” In basic terms, it simply states that the audit programme has to consider the importance of the (quality management system) process concerned. Nothing requires an actual audit of a process! So, why has the mantra of “Process-based Internal Audits” become so pervasive?

Maybe “mission creep” has occurred from the influence of the Certification Body auditors who were required to change their approach to one of auditing process(es), around the time ISO/TS 16949 was published. This era ushered in the use (by CB auditors) of the “turtle” diagram for audit planning, which has become widespread throughout their client base, too.

Although not advocating against the internal audits of only processes, a risk-based approach to the considerations of what to audit and when can be very useful. Empirically, we know that risks occur in business, and they don’t always occur within a process. Traditionally, risks are associated with something new and/or changed or activities affecting an organization:

Product designs & specifications
Sources of supply
Personnel
Technology

By reference to the diagram below, adapted from James Reason’s “Managing the Risks of Organizational Accidents,” (ISBN-10: 1840141050), it can be seen that risks occur throughout an Operation.


Clearly, the selection of a specific process may help when considering what part(s) of the management system to audit, however, further planning may reveal that it’s not always the whole process which should fall under the audit spotlight… It may be a relatively simple activity contained within the process. Perhaps a review of a requirement (customer order) and a subsequent change to that requirement may mean that a second review isn’t as robust. In such a case, auditing the entire process may be unnecessary in determining where the change “slipped through the cracks.” Experience also shows that it can be the interaction between processes where issues manifest themselves – at the interface of two (or more) processes.

It follows then, that without a clear, specific requirement to audit (only) processes, an organization is free to choose a specific audit “scope” and “criteria” if those define something within the quality management system which represents risk to effectiveness in achieving intended results. In addition to considering a process as the scope of an audit, the following also may be used:

A customer and/or regulatory requirement – may be implemented in parts of multiple processes
A physical area or location – a warehouse, for example
A specific requirement from the ISO requirements – when establishing the QMS
A project – improvement, new product design, the implementation of a new technology, etc.
An activity – something which may be part of an overall process

For more help in establishing and managing an effective internal audit program, to meet ISO 9001, AS9100D or the IATF 16949 requirements, contact us at: ISO@the-center.org.




Meet Our Expert

Andy Nichols
Quality Program Manager


Andy has 40 years of expertise in a wide variety of roles and industries, with a focus on quality management systems in manufacturing organizations. In addition to his ISO 9000 Management Systems experience, he has worked extensively with ISO/TS16949, ISO/IEC 17024 and ISO/IEC 17025.

His broad practical knowledge of ‘Quality Tools’ includes: SPC, FMEA, Quality Circles, Problem Solving, Internal Auditing and Process Mapping. He has also been an IRCA and RABQSA accredited Lead Auditor.

To read Andy's full bio, visit click here.




Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.

Friday, June 23, 2017

Process Mapping: Addressing the Elephant in the Room

By: Chuck Werner

When teaching a new group of Continuous Improvement (Lean and/or Six Sigma) students, it’s always critical to emphasize the importance of the first “team” activity of any project or kaizen— the process map.

There are many benefits to process mapping. One is its highly visual nature. The ease of comparison between what we THINK happens and what actually does is another. It also helps to focus on what area(s) of the process are contributing to the problem or performance of the process. To illustrate the first and potentially most impactful output of the process map, let’s consider a very old, well-known story.

The Blind Men and the Elephant


Six blind men once lived in a village. One day, they heard that there was an elephant in the market. The men had no idea what an elephant was. And even though they could not see, they decided to go to the market anyway. Their goal was to gain an understanding of this wonder they had heard about, if only through touching it. The group went to the market square where each of them touched the elephant.

"The elephant is as a pillar," said the first man, who touched a leg.

"No, it is like a rope," said the second man, who touched the tail.

"Oh no, it is like a thick branch of a tree," said the third man as he touched the trunk of the elephant.

"It is like a big fan," said the fourth man who touched the ear.

"It is like a huge wall," said the fifth man who touched the belly of the elephant.

"It is like a spear," said the sixth man who touched the tusk of the elephant.

They began to argue about the “truth” of the elephant, each of them insisting that he was right. After a while, they became angry with each other. A wise man was passing by and saw their distress. "What is the matter?" he asked them. They said, "We cannot agree what the elephant is like." Each man then described what he thought the elephant was. The wise man calmly explained to them, "All of you are right. The reason every one of you is telling it differently is because each of you touched a different part of the elephant. The elephant has all of those features you described."

"Oh!" the men said, happy that they were each right and content in their understanding of the entire beast.

Teams, whatever their purpose, are usually cross-functional. This means they include “subject matter experts” from several areas of the process being studied—such as stamping, fixture operator, welder and inspector. Just as likely, they are drawn from different disciplines within the business, such as finance, maintenance, operations, quality and engineering. Similar to how the blind men only had knowledge of the part of the elephant they had touched, the information and expertise held by each member of the team is often compartmentalized.  Consequently, their thinking regarding root causes, countermeasures, and/or improvements, can only draw from their personal experience of the process, or those parts they have “touched.”

Mapping is the tool that enables us to take each part of the process as experienced and fit them together. By sharing these bits of information (in a systematic approach), and using them to populate a true picture of the process, we get an image that is more accurate. Additionally, each team member becomes more knowledgeable about the process itself. They begin to see how their “piece” fits in with those of their teammates.

This understanding of the whole leads to enhanced performance of the team through an understanding of the internal and external “customers” in the process. It also results in greater improvements, as all the members can bring a larger understanding to bear on the problem or process. It is through Process Mapping that we are allowed to finally see ALL of the elephant. Then we just have to figure out which bite to eat first.

But that is another story…



Meet Our Expert

Chuck Werner
Lean Program Manager and Six Sigma Master Black Belt


Chuck Werner has 27 years of experience in manufacturing, most of it as a Tier I automotive supplier. He achieved his certification as a Lean Six Sigma Black Belt in 1996 and his Master Black Belt certification in 2011. Additionally, Chuck is a certified ISO/QS9000 Lead Assessor, Training Within Industry (TWI) Master Trainer and is certified in OSHA Compliance and Accident Reduction. To read his full bio, click here.







Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at click here.


Friday, June 16, 2017

Keep Your Customers Coming Back!

Five ingredients that are sure to satisfy.

By: Tricia Onesian


Whether you prefer a burger grilled to perfection or a tasty summer salad loaded with sun-ripened berries, there’s no shortage of delicious summer fare at your favorite restaurants. I’m always reminded that the overall experience is far more satisfying when a restaurant serves up delicious food and excellent service. (I consider this a recipe for success!)

What can manufacturers learn from the restaurant industry about a positive customer experience? PLENTY! Taking great care of your customers is important for every industry. According to Lee Resources, 91% of unhappy customers will not willingly do business with you again.

Strive to give your customers the best possible service 
I’ve discovered the five key ingredients that will help your customers become repeat customers.
For best results, mix all of the ingredients together equally—and don’t forget my personal
favorite—#5!

1. Give a Little Extra – Go the extra mile for your customer. Send a thank you gift or give your customer a call just to say hello. Your customers will remember and appreciate a kind gesture. After all, 95% of consumers share bad experiences with other people (Zendesk). Be sure to give them a positive one!

2. Create an Inviting Atmosphere – We tend to only use the fancy silverware when we have guests, right? If your customers are touring your new, state-of-the-art facility or joining you for lunch, don’t just treat your customers as customers—treat them like family. And, make them feel like they are your only customer by giving them the time and attention they deserve.

3. Be Accommodating – Can you imagine if restaurants served dinner for only one hour or charged you for a little more salad dressing? Neither can I. Re-arrange schedules when necessary. Make a concerted effort to be understanding when things don’t go exactly as planned. Do what it takes to make the customer feel like you’re meeting their needs.

4. Become the Expert – Be a trusted advisor and the person your customers can always count on. Brush up on your skills and know your products inside and out. Think of it like this—once you’ve found the perfect burger, why would you go anywhere else? Your customers will rely on your wisdom instead of a competitor’s.

5. Serve It Up With a Smile – No one wants to deal with a grumpy server. The same is true for your customers. Be positive, helpful and always smile when you speak!

In a world where customer service is often lacking, give your customers more than they expect.
Whether it’s a second helping of food or amazing service, you’re bound to get repeat (and satisfied) customers.



MEET OUR EXPERT

Tricia Onesian
Inside Sales Representative


Tricia became passionate working with clients more than 25 years ago in various customer service and management positions with paper manufacturing and warehousing companies. Since joining The Center in 2016, Tricia has been enthusiastic about sharing how Michigan manufacturers can enhance quality, improve efficiency and propel growth. She is currently certified in ISO/TS 16949 Internal Auditor Training and as a Lean Manufacturing Champion.

To read Tricia’s full bio, click here





Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.



Friday, June 9, 2017

Engaging Your Evolving Workforce

Four Steps to Propel Success


By: Jamie Headley


For the first time in our nation’s history, four generations (and soon to be five) work alongside each other. Manufacturers now find themselves trying to balance age gaps that can span upwards of 50 years between the youngest and oldest employees. What can be done so every generation of your workforce is engaged? Here are four key actions that management should take to help their employees thrive:

1. Embrace different values – Each generation brings an array of skills and experience to the workplace. Different generations also are known for being motivated by and valuing different things. For example, Baby Boomers tend to be loyal to a company and value perks and prestige, while Millennials are highly engaged when they are passionate about a particular issue or cause. It’s critical for leaders to embrace each generation’s values because the one-size-fits-all approach no longer works.

2. Encourage mentoring opportunities – Promote a culture of generation-to-generation mentorship. Whether it’s a knack for utilizing the latest technology or possessing decades of in-depth knowledge on a particular subject, your staff should take advantage of their co-workers’ invaluable expertise. By creating a mentoring system in which the youngest employees learn from the seasoned professionals and vice versa, you will realize relationship-building at its best. The mentoring concept is an important element in the area of succession planning also.

3. Provide flexible training options – From onboarding to yearly training, be open to new ideas and flexible with each approach. Younger generations tend to have shorter attention spans, so training works best when it is broken down in segments that are five minutes or less. (Yes, using mobile devices to get your message across is a must.) Other employees might benefit from just-in-time learning—the skills are imparted immediately to help avoid loss of retention due to a time gap. Not sure which option is best? Ask your team for feedback.

4. Lead by example – Sometimes, the best way to learn is to listen. Develop unique and specific relationships with each person you have the opportunity to work with. A leader who encourages these one-on-one relationships focuses on the staff’s generational needs and values, creating an environment where employees want to work. So keep the lines of communication open.

While it takes time and a concerted effort to build and maintain a culture where multiple age groups are engaged in their work, generational differences actually can be beneficial to the overall operation—and success—of your business.


MEET OUR EXPERT

Jamie Headley
Senior Business Solutions Manager



Jamie Headley is a Senior Business Solutions Manager at the Michigan Manufacturing Technology Center (The Center). She works as an advisor to Michigan manufacturers in the Southwest region of the state, helping them to “manufacture smarter.”  Jamie is a seasoned operations professional with expertise in change management, strategic planning, leadership, process improvement, lean implementations, cost containment and operational excellence. To read Jamie’s full bio, click here.






Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.











Friday, June 2, 2017

Risk in ISO 9001:2015 Transition?

By: Dale Wicker
In the ISO 9001:2015 standard there are two basic terms encompassing risk: risk-based thinking and the compound term risk and opportunities. Risk-based thinking is intended to be the system or approach an organization takes when considering risks and opportunities. These risk and opportunities are only those that may affect the organization’s ability to enhance customer satisfaction and consistently meet customer requirements, and, as applicable, statutory and regulatory requirements.

In ISO, risk is defined as “the effect of uncertainty,” and when used is implying a negative sense, which is in agreement with the Merriam-Webster Dictionary definition. So, in every instance in which the term risk is used in the new standard, it is used in the negative sense and never in the sense of a positive effect.

Opportunity, however, is presented in a less clear manner. For instance, in NOTE for Clause 6.1.2 states, “Options to address risks can include . . . taking risk in order to pursue an opportunity…” which agrees with the general understanding of opportunities, where actions are put in place for favorable or positive effects. However, throughout the standard it seems to use risk and opportunities together in a negative fashion. This seems to imply that we are to look for opportunities in the negative effects of risks and take action to prevent them or mitigate them. While this is true, it tends to place opportunities in a negative light and not line up with the general understanding. For instance, it would be a good practice to also consider positive effects that may occur that could lead to better products, improved processes, cost reductions, etc. This would line up with the general understanding of opportunities.

So what’s all this risk rattling mean?

David Hoyle, writer and Quality Management coach explains:

• An uncertainty presents a risk if its occurrence may have a negative effect on an expected result and is therefore relevant.
• An uncertainty presents an opportunity if its occurrence may have a positive effect on an unexpected result and is therefore relevant.

So, what do you need to do? 

Don’t panic! You’ve probably been applying risk-based thinking and didn’t know it! For instance, when you analyzed nonconformities and took action to prevent their recurrence, you were addressing risk; when you introduced training, you were addressing risk; when you did contract review, you were addressing risk; when you put in place controls over design, purchasing, production and service delivery, you were addressing risks. If you are currently ISO 9001 registered, none of this should be new to you. You already do these things!  The only thing that is new is the definition, which is covering a lot of what the old preventive actions required anyway.

In summary, your organization needs to have a system or approach for risk-based thinking that is promoted by leadership (Clause 5.1.1) that addresses your risk and opportunities (Clause 4.4.1, 5.1.2, 6.1.1, 6.1.2, 9.1.3, 9.3.2, and 10.2.1). You  must assess the risk and opportunities in light of meeting customer, statutory and regulatory requirements, as applicable, while enhancing customer satisfaction.



Ask Our Expert

Dale Wicker
Quality Program Manager



Dale Wicker is a member of The Center's Quality Team. He manages and delivers training and assistance to organizations in the areas of quality improvements and environmental management systems. Some of his projects involve support with the implementation of a Quality Management System including: ISO 9001, ISO/TS 16949, AS 9100 and ISO 14001. Dale also conducts training and provides consulting on the supporting tools of Quality Systems. To read Dale’s full bio, click here.






Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.