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One of the newest requirements to both ISO 2015 & AS9100 2016 is the whole concept of Context of the Organization. The intent of this requirement is for organizations to take stock of all of the internal and external influences on their business. The thinking is that a company really cannot properly build their QMS until all of these influences are understood.

One of the sub-requirements is to define the “Interested Parties” to the business, and to identify what their needs are. Interested Parties are defined as those that effect your QMS. Conversely, management need not consider entities that do not have an effect on the QMS, although this should be a very short list, because as I preach to my clients, a “B” can be functionally swapped out for the “Q” in QMS as it is actually a Business Management System for the entirety of the organization.

So what do you have to do? Excellent question because any requirement means that something is expected to be done. A simple analysis at the next management review meeting will suffice, using a tool such as my attached Interested Parties Worksheet. Only parties that have an interest in how your company performs need be examined. Once this is done, the management team determines whether any changes to the QMS are needed based on this information, and then duly noted in the management review minutes. Refreshing this activity then becomes an annual exercise.

Contact me to see how I can help you develop your Context of the Organization process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

Don’t panic about risk…

In ISO 2016, risk-based thinking is the most dreaded part of the new standard for most companies. Risk really does permeate every function of any organization, so the increased emphasis from every quality standard is certainly justified and good business practices. The most common question I get is “How do I even start?” Getting your management team together to answer these 5 questions will get you started on the right track.

 

 

 

 

 

 

Contact me, right away, to see how I can help you implement risk-based thinking as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

 

The 2015 revision has eliminated Preventive Action. Actually, it has really been repurposed and branded as “Risk”. Most companies are typically doing risk management but not calling it risk (quoting, contract review, pFMEAs, etc.). The objective of the new emphasis on risk is to have companies address uncertainty in processes that will affect the quality of the customer’s delivered goods or services. As with preventive action, things such as trends, history and customer feedback will be drivers of risk mitigation.

Under 2015, risk-based thinking (RBT) permeates every facet of the company with the expectation that you look at everything with a “risk-based eye” (what can go wrong and what do we do if it does). When addressing risk in your Quality Management System, be sure that you look beyond simply determining the “chance” that something happens and evaluate “the effect of an uncertainty” on your business and QMS objectives.

There are five (5) attributes to enhance risk management:

1. A company should accept accountability for their risks and develop comprehensive controls and risk mitigation strategies.

2. Risk management should be a part of a company’s continuous improvement strategy.

3. Identify and train individuals with accountability for risk management.

4. Decision making within the company should include consideration of risks and the application of the risk management process where appropriate.

5. Maintain consistent and periodic reporting to all stakeholders of the company’s risk management performance.

In the real world, we all know that extensive analysis and identification of high risk orders will not prevent the president from overriding it and saying “I understand, but we are taking this order!” That is fine, the intent of the standard is that you go into everything with your “eyes wide open” by acknowledging, and consciously accepting any risk (hopefully with additional countermeasures put in place to minimize it).

Contact me to see how I can help you implement risk-based thinking as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

At first blush, ISO 2015’s removal of the requirement for a quality manual has a lot of quality managers thanking their lucky stars! However, when you ask yourself “Can I really do that?” two compelling reasons will dictate that the answer is probably going to be a resounding no.

The first reason is that for decades the quality manual has been the top level, policy document in almost every company, in every industry. Old habits die hard, and most organizations will not be willing to change this just because the latest iteration of the standard says they can.

The second, and most important reason is that your customers probably won’t let you. Customers like quality manuals because it provides them a snapshot of your entire QMS in a single document. They don’t want to wade through a dozen individual procedures, policies and work instructions, especially if a quality manual review is the first tool in their new supplier screening process.

There is a third reason that will apply to some of you; your other QMS certifications won’t allow you to drop the quality manual. For instance, Aerospace’s AS9100 says, “You will maintain a quality manual, period.”

I advise all my clients not to abandon their quality manual, however, I do recommend they simplify them. Quality manuals can often be 20-40 pages long; I show them how to create a 4-page quality manual that will pass ISO and AS9100 with flying colors (yes, you read that correctly).

Contact me to see how I can help you do the same.

920-841-3478

Steve@TheRightApproachConsulting.com

 

 

 

 

Vince Lombardi said “The achievements of an organization are the results of the combined effort of each individual.” That is kind of what ISO’s new verbiage around Interested Parties is all about, all of the people & entities that influence a business.

ISO officially defines interested parties as those that effect your QMS. Conversely, management need not consider internal or external entities that do not have an effect on the QMS. The key here is to focus on the relevant interested parties.

So… what are some examples of relevant interested parties?

• Customers: The people who use your product directly affect your ability to satisfy their needs. You need to understand the needs, expectations, and requirements of these people, because how they will use your product or service determines how your products or services need to be created. These can be some of your most important interested parties.

• Governments & regulatory organizations: Many industries have legal requirements that their products and services need to meet, and there can be a great cost to not meeting these. In addition, it’s important to understand the expectations of other organizations, such as industry watchdog groups, which might identify what levels of performance and durability are expected by your ultimate customers.

• Employees: Even if your employees don’t buy or use your product or service, they will want to work in a safe and comfortable environment that creates products and services that will meet the needs of your end customers. Nobody wants to create faulty products or services.

• Shareholders: Since your financial bottom line is directly affected by the costs of your products or services, your shareholders will be interested in how well your QMS performs. In particular, the expectations around continual improvement could be extremely important for this group of interested parties.

Contact me to schedule an ISO 2015 GAP Analysis & receive a free Implementation Plan.

920-841-3478

Steve@TheRightApproachConsulting.com