Friday, July 14, 2017

Drowning in ISO Paperwork?

How to Stay Afloat


By: David Bradley

ISO 9001:2015 blends documents and records into a single concept called “Documented Information” and no longer requires any documented procedures. If you’re still in the ISO transition phase, you might be thinking that certain procedures for handling documents and records got a lot more complicated—but did they?

If your procedures for documents and records served you well under the 2008 version, they will probably do the same for the 2015 version. Just because they are no longer mandated does not mean they should be discarded. (This holds true for any document or record you had under the 2008 version.) So, how can you tell if you can discard any of your old documents or if you need additional documentation you did not have in the past?

To help prevent paperwork overload, ask yourself the following questions:

1. Is the document required by the standard? If the standard requires you to have documented information, does this document meet that requirement? If the answer is yes, then you need to keep (or perhaps generate) the document. Or, you may need to modify the document to meet the requirements or intent of the standard. If the answer is no, then proceed to the next question.

2. Is the document required by either your customer or governmental (regulatory) entity? If either your customer or the government requires the document, then you need to keep it. As with question one, you may need to modify it to meet the requirements. If neither your customer nor the government mandates the document, then advance to question three.

3. Is the document required? You may have documents that are not required by anyone external to the organization, however, the absence of the document could result in unwanted variation. Think of pain here. If we remove the document, could you experience pain? There also may be pain because of the document. Perhaps the document prohibits the flexibility required to effectively and efficiently engage the process. If it is required by necessity, then you must keep the document. Again, modification may be necessary for the document to meet your operational needs. If it is not required by necessity, then jump to the final question.

4. Is it desirable to keep the document? While some documents are not required, they still might be worthwhile to keep.

By asking these questions, you can quickly identify documents that will remain part of your Quality Management System and those that can be discarded. When tossing documents, it’s often helpful to keep a copy in archive.

In any instance, your documents should be up to date with the requirements and your processes.
As processes are performed, verify the documents are still the appropriate reflection of the current practice. As you engage your customers, verify any change to customer requirements. Also, many regulatory documents are reviewed or revised on a yearly basis. Keep track of those changes as well.

Your documentation should assist you in providing a quality product or service. Remember, a well-run system will work for you, not the other way around. Use common sense and frequently ask yourself the previous questions to help maintain a successful Quality Management System that keeps documentation at a minimum level—and your head above water.



Meet Our Expert

David Bradley
Quality and Environmental Services Program Manager

David Bradley has been The Center’s Program Manager in QMS for 18 years and is a member of the Quality Team. His expertise includes ISO 9001, TS 16949, AS 9100, ISO 13485 management systems, Automotive Core Tools, ISO 14001 Environmental Management Systems and OHSAS 18001 programs. To read David’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, July 7, 2017

Build (and Maintain) a Thriving Business

Align Your Mission, Vision and Strategic Plan


By: Ron Quinkert


Most businesses are formed because of an owner’s vision. But, what happens when that vision isn’t conveyed to the employees, and it doesn’t evolve into a carefully drafted mission statement and strategic plan? Unfortunately, this is a common problem—and it sets up the business to fail.
Whether you’re a small or mid-sized manufacturer, you must be keenly aware of three essential elements to build and maintain a successful business—a mission statement, a vision statement and a strategic plan. Leadership must be accountable for making sure all employees’ work continues to support each area. Let’s take a closer look…

Mission Statement
According to Google, a mission statement is a formal summary of the aims and values of a company or organization. Leadership must emphasize the current mission statement to all employees and clearly communicate the purpose and primary, measurable objectives. Remember, your mission is your company’s purpose and should actually inspire and unite employees around a common good.

Vision Statement
A vision statement helps describe the organization's purpose. Vision statements also include the organization’s values, give direction for employee behavior and help provide inspiration. While the mission statement is often in broad terms, the vision statement narrows it down. A key point to consider, a vision statement is how to accomplish the mission, plus it’s measurable.

Strategic Planning
Per Wikipedia, strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy. It may also extend to control mechanisms for guiding the implementation of the strategy. A strategic plan is a living document and shouldn’t be hidden in a drawer. When opportunities arise or shift, revise it! Don’t forget, any changes need to be shared with the entire organization.

Once you’ve rolled out your new mission, vision and strategic plan, here are a few ideas to help keep your workforce engaged:

Surveys
Ask questions about mission, vision and values to see where your staff stands. If you find that your employees’ answers are inaccurate or inconsistent, you’ll need to help them better understand how to contribute effectively.

Decision-making
When a company outlines its mission, everything and everyone begins to head in the same direction. It becomes apparent who is working on the mission—and who isn’t—and allows management to take the necessary steps to get the team on board.

Company-wide Meetings
Regularly share news about how the company is striving to reach its goals. Not only is a well-informed workplace much happier and more productive, but this also helps the entire organization focus on what’s truly important.

Individual Goals
By analyzing how an employee helps achieve the company’s mission, vision and strategic plan, management can make it more relevant to the individual. This not only helps with engagement, but makes the work more meaningful.

Set Up Your Business (And Your Team) for Success
Need help generating or revising your mission, vision and strategic plan? The Center is your best resource. Contact Ron Quinkert today to get started: RQuinkert@the-center.org



MEET OUR EXPERT

Ron Quinkert
Senior Business Solutions Manager

Ron Quinkert is a Senior Business Solutions Manager with the Michigan Manufacturing Technology Center and has 20 years of automotive sales and manufacturing experience. He works directly with manufacturers in seven Southeast and Central Michigan counties. He is a seasoned professional with expertise in team building, automotive product and manufacturing processes, tool design, operational audit practices, procedures and improvements. To read Ron’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 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.