High Performance

It is our strong recommendation that organizations do not make changes to their quality management systems until the formal standard is released in 2015.  
                           
My son just bought his first vehicle at the age of 15. His pride and joy is a 1995 Jeep Wrangler. No, he doesn't have a license but at the age of 15 ½ he has a learners permit and has graced the streets and sidewalks of our fair city with his presence. Performance Evaluation, section nine, is one section of the new ISO standard that I can truly say I am living out each and every time my son takes me for a training drive. I failed to mention that the Jeep Wrangler is a stick shift. On our way home from purchasing the vehicle my son was insistent and resolute that he knew how to drive a stick shift. After all, how hard could it be? You just Clutch, Shift, Gas and away you go..... so he proclaimed and I, being the good father, tried to inform him that it was a lot harder than he thought. If you have a child you will know that sometimes they just have to learn for themselves. So after thirty minutes of nagging, I pulled down an old farm road, parked the Jeep in some poor soul's driveway, and allowed my son to give it shot just to shut him up. After seven times stalling the Jeep and creating a crater in the farmer's driveway my son turns to me and says, "Dad maybe you better drive the rest of the way home." He had evaluated his performance and the empirical evidence led him to some immediate correction, corrective action, and preventive action all under the watchful eye of Top Management, Me.

Section Nine of the ISO 9001:2015 standard simply stated is, how we as a healthcare organization evaluate our performance as we traverse the highways and bi-ways of patient care, organizational advancement and continuous improvement. Just like my son driving a stick shift, section nine gives us four areas where an organization needs to focus: 1. The Clutch, Customer Satisfaction; 2. The Shift, Data Analysis; 3. The Gas, Internal Audits; 4. The License, Management Review.   
 
In the new standard Customer satisfaction primarily remains the same and once again maintains precedence for the organization to evaluate its quality management system. Here is a very interesting change in the verbiage. The organization shall monitor customer perceptions "of the degree"to which requirements have been met. Did my son get the Jeep into first gear? Yes, but the white padded whiplash collar might indicate that my requirements for a safe trip were not met to the degree that I had anticipated. Our patients may leave the hospital healthy but did they hate the experience? To what level or degree of excellence have we met our customer's requirements? Anticipate this change to necessitate value data. Another interesting change is that the organization shall obtain information relating to customer Views and Opinions of the organization and its products and services. You can anticipate a change to the wording of this requirement but not the intent. This requirement is very objective in its nature but the information "Real to our Patients" is very subjective to the success of our organization. My son's opinion of his driving as you might imagine is far greater than mine, however it is I his customer, whose opinion must grant permission for him to drive. So it is with hospitals. We may think that we are doing a great job and have the data to prove it but the objective opinion becomes subjective reality as our patients venture on to the hospital down the street. Now that we have the clutch in, let's shift gears.
It is in the analysis of data; the factual based decision making that allows any organization to shift from one level of excellence to another. This requirement is reflective of the ISO 9001:2008 requirement but now the requirements have been expanded. We have seven gears that we can use to propel us to the next level. The Analysis and Evaluation section states that the outputs of Analysis and evaluation shall be used to:   a) Demonstrate that our services provided to our customers are conforming b) Enhance customer satisfaction c) Ensure our QMS is effective          d) Achieve the objective of our business planning e) Determine the level of performance of our processes f) Determine the level of performance of our suppliers, vendors, contractors g) Find opportunities for improvement. It is my opinion that the accreditation and certification bodies will expect to see some evidence presented for each of these requirements. So now we have it in gear let's release the Clutch and Give it some Gas.

You will be happy to hear that for the most part the Internal Audit process remains the same with negligible changes to terminology, so we will move on to the last portion of section nine, the Management Review.
Just like that gas pedal that my son seems to be so fond of, Management Review is truly what is designed to propel the organization to success. While many of the requirements are verbatim from the 2008 version we want to highlight the most significant changes or the high octane requirements. In section 9.3, Management Review, it is now required to provide objective evidence in the minutes that changes in external and internal issues that are relevant to the QMS, including its strategic direction, are included. What does that mean, Woody? If you will recall when we first started this journey together in section 4. 1 and 4.2, we identified our own hospital context (what on the inside of our hospital are our strengths and weaknesses) and the needs and expectations of our outside interested parties were. Now it is time to see where we are succeeding, at risk, or have opportunity to excel as it pertains to those items identified. For our relevant interested parties if our performance, trends or indicators show that we are not meeting their needs, then these issues need to be brought to the attention of top management and action taken, as appropriate. Brand new to the management process is the inclusion of information or issues concerning external suppliers. The last and most intriguing requirement for me is the inclusion of the effectiveness of actions taken to address risks and opportunities. If you will recall back in section six, we were to identify and react to risks and opportunities within the organization. Now is the time for top management to see how we did and how effective our actions were. Now that top management has a plethora of information as to the status of the QMS, if can effectively allocate the resources needed, the gas if you will, to move the organization forward.

If you walk through section nine of the ISO standard step by step coordinating your activities and processes you will find that clutch, shift, gas might be tricky at first, but over time and with practice, you will find that you stall out less and less frequently.

Hope this helps.

White Knuckles on the Roll Bar

Woody

Who killed the Management ISO Representative?

“Professor Plum in the Break Room with the ISO 9001:2015 standard!”

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

One of my first responses to the new standard was, “Where did it go?” “What happened?” “It isn’t in there!”  “They killed the Management Representative!”  In the ISO 9001:2015 standard, at this time, there is no direct call out for the position of Management Representative.  However, if you look closely you can see that under section 5.3 Organizational roles, responsibilities, and authorities, you can see some of the same language used to describe the activities previously given to the management rep.

My second response was, “I’m not sure that I like this” after all who will ultimately be responsible for tying together all the loose ends of our quality management system?  Who will be my pipeline of communication to my organization on ISO matters?  Who will carry the candlestick providing illumination and insight to all the ISO questions in the organization?  Who will ride shotgun when the auditors show up?  Who will cut through all the ISO jargon that comes with our audit report?  Then as if a mighty wrench opened the valve of understanding it dawned on me, Management!  Management is the one who will fill the gap.  We killed the Rep. but have solved the mystery of how to get management truly involved in the quality management system.  We make everyone in a management position or role responsible for the success of the organization.

The ISO 9001:2015standard has once again maintained section 5 as the Management Section of the standard.  Many of the requirements are merely a reiteration of what was required in the 2008 version or were intended and implied, if not directly stated, as a requirement.  For this article I want to bring your attention directly to three profound changes, not only in the ISO standard, but, also how we will need to shift our perspective of the management role in the organization.

5.1.1 (d) Top Management Shall….. ensure the Integration of the quality management system Into the organizations Business Processes.

Can an organization say that they are compliant with the ISO 9001:2015 if:

·         Management washes their hands of the ISO program by sending it to this department or that department for implementation and maintenance, only giving it their attention when the auditors show up?

·         They never include such processes like finance, accounting, capital investment, investor relations, etc… into the quality management system.

·         Management has tasked one individual (the Management Rep.) to be the ISO super hero and develop, define, implement, maintain and continually improve the quality management system.

The new standard seems to make it very clear that the implementation of an effective QMS is always inclusive of the business processes that make up a very important part of the system.  This is very evident and relevant if you consider that the first section of the ISO standard is primarily focused on identifying and dealing with Risk to the organization both internal and external.  Is not one of the biggest potential risks how we run our business and our finances?  The effective ISO system is inclusive of all we do as an organization.  It is what we do, who we are, and there is no process in our organization that does not have an impact.

5.1.1 (i)  Top Management Shall ….. engage, direct, and support persons to contribute to the effectiveness of the quality management system.

Top management is now tasked with recruiting their personnel to become a participant in the development of the organization not just a spectator.  Top management is tasked with not only the direction of the organization, but also to be the directors of their people achieving organizational effectiveness.  Top management is tasked with ensuring that each person not only has a part, but is effectively playing that part for the success of the whole.  In short management has become the Generals of a great army of Management Representatives.

5.1.1 (k)  Top Management Shall..... support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

This has to be my favorite part because, even though we killed off the management representative, now we have top management actively involved in the mentoring of other relevant management roles so that they in turn can now demonstrate their leadership throughout the organization.  If each member of a good top management team were able to teach, train, mentor, and release two good department managers a piece, where would the organization be in a very short time?  Good leadership needs to replicate itself in those in authority below them.  We can literally create a QMS that has no need of an ISO expert, an ISO champion, an ISO department or even a management rep.  We now have an organization filled with business leaders on all levels effectively dealing with the risks that face an organization and leading their staff, their department, their process, and their organization to continual improvement and success.

So prepare the Eulogies and write the Obituaries.  It’s a great new day in ISO.

See You in 2015

Professor Plum

ISO 9001 Tips and Advice-Magnitude Level

ISO 9001 Tips and Advice 

Magnitude Level

Twenty years ago when I first started out in ISO the president of the company I worked for made a very insightful evaluation of the ISO 9001 standard. He said, "For years my people have been making stupid mistakes over and over, but with our Corrective Action process now they have to get creative to mess up!" He had captured the essence of corrective action. It's okay to "mess up" it's not okay to repeat it.

The question remains, how do you create a corrective action system that works and not a system that you have to constantly work? The answer is Magnitude Level.

Customer Complaints (required):  
Any customer complaint above “X” dollars to the customer or our organization, any customer complaint resulting in injury to the customer, any complaint that is reoccurs “X” number of time within “X” time frame, any customer complaint that at the discretion of the Management Representative or Management Review team requires formal corrective action.
Magnitude levels can be both Objective and Subjective.
Process Performance (required):
Any goal or objective that falls out of acceptance criteria by less than 5% for less than or equal to two months requires correction.
Any goal or objective that falls out of acceptance criteria by less than 5% for more than two months requires formal corrective action.
Any goal or objective that falls out of acceptance criteria by more than 5% for one month requires formal corrective action.
Now you have a system that my organization can actually live with and will provide return on investment.
Woody
ISO Consultants for Healthcare