Free ISO 31000 Webinar

Please join us for the free upcoming ISO 31000 webinar on June 11th. Simply click the following link and fill out the short form to confirm your spot!

https://uk189.infusionsoft.com/app/form/iso-31000-free-webinar


Thank You,

RISKY BUSINESS

ICH achieves ISO 31000 Risk Management Certification

“It isn’t the Risk that scares me, it’s the uncertainty that comes with it.” Anonymous

“Healthcare”

You don’t need to google that word very long to come to the clear understanding that this industry has to deal with an incredible amount of “risk”.  Just looking at some of the terms that healthcare professionals use on a daily basis will give you some insight; risk manager, adverse event, sentinel event, near miss, high risk drugs, wrong site/wrong patient/wrong procedure, infection prevention and control, unanticipated death, patient safety system, physician rehabilitation, infectious blood, radiation protection, nuclear medicine, informed consent, restraints and seclusion, hazardous materials, emergency management…all this from page one.  As I have developed newsletters, webinars and class materials on the ISO 9001:2015 Standard, I can’t help but become overwhelmed by the stated and implied requirements for the identification, analysis and mitigation of risk and opportunities.  So it shouldn’t come as any great surprise when I began to realize that this new standard is significantly raising the bar and work load on healthcare organizations when it comes to dealing with risk and opportunity.  Here at ICH, we need to change the way we do business if we expect to assist those who have chosen to be our clients in changing the way they do business.  How will we help organizations who encounter risk on a daily basis control, mitigate and eradicate all the risks they encounter? 

That question led us to ask ourselves another, “How do we propose to help organizations navigate their way through all the current risks that they encounter, especially in light of the ever looming prospect of a new revision to the ISO 9001 Standard?  The answer was to do that which we would encourage our clients to do: seek out and learn from the best of the best.  Enter the ISO 31000 Risk Management Standard.  We realized very quickly how integral this standard can be for an organization when coupled with the understructure of a strong and sustainable business management system.  We saw how the 31000 standard fits hand in glove with the 9001 standard’s latest revision.  We came to grips with the fact that organizations who truly understand risk management need not be concerned with the changes in the new standard, but should embrace it as a wonderful tool to stop the madness that healthcare risk imposes on each and every person in the organization.  As healthcare organizations travel through their journey from compliance, to performance, to risk mitigation and finally to opportunity, this standard walks by their side, providing the guidance needed to see hope become reality… the hope that “we truly can make a difference on the face of healthcare in America”. 

It is with this thought in mind that I am very proud to announce that ICH has become the first healthcare organization to achieve certification to the ISO 31000 Standard in the United States.

We look forward to bringing all that we have learned to your organization at your request.  Healthcare has always been a “Risky Business”.  However, at ICH we hope to remove a little of the pressure from your shoulders. 

Woody Conway

For more information on the 31000 standard or 31000 consulting services contact:  Rebecca Detling

937-569-4134  

rdetling@ich-global.com

Avoid Titanic Failures with ISO 9001

Titanic Failures

             ISO 9001:2015 standard:ISO 2015 Life Preservers-On Sale Now!

It is our strong recommendation that organization do not make changes to their quality management systems until the formal standard is released in 2015.

White Star Line: Titanic

The story of the Titanic is amazing and great movie. So many things could and do go wrong and have such cataclysmic effects. When you look deeply into the story and history of the Titanic, the question surfaces, "What were they thinking?" Here are just a few of the things that went wrong some you may know, some you may find quite prophetic as you and your organization plan for the ISO 9001:2015 transition.

-Only 20 lifeboats.

-Compliant with code for a 10,000 ton ship, there was no documented code for a ship of 46,000 tons like the Titanic.

-There was only 6 - 7 hours of testing and never at any testing at top speed for maneuvering.

-Life safety training only involved lowering two life boats, giving an inaccurate time of evacuation.

-Binoculars and Searchlights were in short supply.

-State of the art Marconi wireless telegraph system had just a few people trained to operate and/or receive messages.

-There was a fire in the coal bunker that started just prior to the voyage and took several days to extinguish. It is believed the fire may have weakened part of the ship's hull, which aided in the sinking.

-Four cautionary warnings of ice were received between one to six hours prior to the collision.

So why all the statistics and the history lesson? It's in the history that we learn what mistakes not to make.

The ISO 9001:2015 standard has gone to great lengths to encourage an organization to take a long hard look at what the risks and opportunities are and then to proactively respond to them. Section 6 of the ISO standard ties all risk and opportunity assessments together into the planning process for mitigation or continual improvement. We can no longer only look within our organization for threats and opportunities for advancement; we must also look at the empirical data that surrounds our context for avenues of success.

The very first requirement of section 6, requires organizations to include issues (Risks and Opportunities) identified in 4.1, understanding the organization and its context and 4.2 needs and expectations, or interested parties in their quality management system planning. If you had been on the board of directors for the White Star Line, the creators of the Titanic, what would have gone into your planning process?

6.1.1 a) Would 6-7 hours of testing at partial speed given you the assurance that your organization could achieve its intended results? The assurance the ship would safely arrive?

6.1.1 b) Would 20 lifeboats although very much compliant with the "Codes and Standards" of the day, met your criteria to prevent, or reduce, undesired effects?

6.1.1 c) Would the revolutionary Marconi wireless telegraph system have shown evidence of achieving continual improvement?

What would you and your organization have done differently, given the opportunity? What would your strategic plan for success have addressed?

6.1.2 a) Would you have taken actions to address these risks and opportunities, maybe purchased a few more binoculars and search lights?

6.1.2 b) Would you have delayed the launch to integrate, implement and evaluate the effectiveness of the lifesaving protocols?

Any one singular action take to address the known risks would have either decreased the number of lives lost or could have potentially prevented the collision with the iceberg altogether. Section 6.1 closes out the section on Quality Management System Planning with a wonderfully freeing statement. "Actions taken to address risk and opportunities shall be proportionate to the potential impact on the conformity of products and service".

You may feel your organization is just waiting for an iceberg to come floating along and all is lost. However, all is not lost, yet; can you take just one small step today? Start by identifying the biggest risk and begin to address it. Find the easiest risk to correct and address it.

Prior to the voyage, if the Titanic had adequate equipment and supplies, proper testing and training, cautionary warnings heeded and safety plans practiced, many lives could have been saved. If the voyage had been delayed to extinguish the fire in the coal bunker of the Titanic, the great movie may have had a much different ending!

The ISO 9001:2015 standard is only asking you to assess and address those things that could sink you and your organization, to ensure a desired ending.

ISO 2015 Life Preservers-On Sale Now
Woody Conway, ICH Lead Trainer
RABQSA Certified Lead Auditor

SO NOW THAT YOU FINALLY UNDERSTAND THE 9001:2008 STANDARD…“WHY CHANGE EVERYTHING?”

It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.

“Just when you thought it was safe to go back into the water…”  It wouldn’t surprise me that many of you are feeling this way as the new ISO 9001:2015 standard looms on the not so distant horizon. 

When you think about it, isn’t that what ISO has been preaching for years, Continuous Improvement?  It is refreshing to know the International Organization for Standardization practices what they preach.

When people ask my goal as a consultant, teacher and auditor, I reply that my job is to ensure the organization sees Return on Investment, Litigation Security and most importantly, Patient Safety or Customer Satisfaction.  When you look at the new standard you can’t help but notice the heightened awareness to RISK.  Risk that an organization might face can come in the form of a thousand different possibilities like little piranhas that can swiftly eat away at the success of an organization or it can come in the form of a great white shark that can immediately devastate an organization. 

What the new standard is attempting to accomplish is to set up a series of life guard stands for an organization whereby the threat can be identified far off in the distance before it can do any real harm.  In section 4 of the ISO 9001:2015 standard the organization is asked to take a good hard look at itself, its customer and any other interested parties that play a relevant role in the success of the organization.

           

                                                 

As the organization begins to evaluate their context, “the pool of water that they are swimming in” they very quickly discover that they themselves may be the cause of some of their greatest risks.  Maybe due to resource constraints, equipment constraints, facility constraints, etc., they may have reached their capacity to fulfill customer needs.  The ISO standard simply asks us to identify and then, in a controlled fashion, mitigate those risks.  Maybe we take swimming lessons and develop a stronger stroke so that we can stay ahead of the competition.

In our current culture customers demand higher levels of quality without additional expense. As an organization clearly identifies these needs and expectations, the risk to the organization will be revealed.

If we identify what it is that our customers truly want and expect, we can now begin to address these issues, not only for the good of the customer, but also for the financial strength of the organization. An organization can maintain cost and see a nice profit, if they change their culture.  To begin to change this culture, an organization needs to improve processes and build quality into the process, instead of inspecting it into their processes. They must work to reduce the number of process failures to consistently and reliably reproduce the product. By doing this, we can feed the sharks what they want instead of letting them eat away at our success.

“Interested party” is the name the ISO standard has given to all others who hold a relevant role in the success of an organization.  This category can be large; however they are not very difficult to manage.  Regulatory bodies want their codes to be complied with; investors want their money; suppliers want their invoices paid.  The smart organization will identify, assess and mitigate the threat that each interested party plays in their success.  If my supplier, my “swim coach”, isn’t helping me stay ahead of the competition, I have to get a new swim coach/supplier.  If I ignore the “Do not swim in shark infested waters” sign I may need to get a bigger sign or put up larger barricades.  Identifying risk from interested parties can keep our organization healthy and safe.

When you believe in your organization strongly enough you will see that Identifying, Assessing and Mitigating the RISKS to your organization is something that you will grow to appreciate.

See You in 2015 and enjoy your safe swim.