What's The Cost of NOT Having a QA or SMS?

The following was in the news today:

Ga. peanut company officials indicted in contamination case

11 Alive News: 11:59 AM, Feb 21, 2013  

WASHINGTON -- Four former officials of the Peanut Corporation of America were named in a 75-count indictment Thursday on charges related to salmonella-tainted peanuts and peanut products.

The charges cap an inquiry that began in 2009 after the Food and Drug Administration and Centers for Disease Control traced a national outbreak of salmonella to a PCA plant in Blakely, Ga.

The salmonella outbreak sickened more than 714 people in 46 states and may have contributed to nine deaths, the CDC reported. The illnesses began in January of 2009 and led to one of the largest food recalls in U.S. history, involving thousands of products.

An FDA inspection of the plant found dirty, unsanitary conditions. The company's own testing had found salmonella contamination, but it continued to ship its products, according to the FDA.

In some instances, the company had the product tested again by a different laboratory and got a clean test result, FDA officials said.

Here we have an excellent example for Food Industry Safety Management Systems. The FDA complains that it does not have enough resources to really inspect all food processors. Why doesn’t the FDA require Safety Management Systems for all food processing facilities? When SMS is mandated, the regulators’ oversight becomes much easier to implement. The focus from Inspection is turned to Assessment of the System. 

This incident also points out the need for Upper Management of any company to have a moral obligation to assure the safety of the public whom they serve. It was determined, before shipping, that the batches of peanut product were tainted with Salmonella. It was a choice by the CEO to go ahead and ship the product. The cost of Non-Quality certainly outweighs the cost of having a working QA SMS Program....your thoughts.

Carnival Triumph: Evidence of Lack of Control.

Safety Management System Quality Assurance could have Triumphed in this event:

As I hear about events, like BP Oil rig, Batteries in the 787, Newtown...etc. Now the Carnival cruise ship Triumph. My Quality Assurance mind automatically goes back to the same thoughts. What will the Root Cause Analysis show of this event. Yes there was an engine fire. I researched Carnival incident history and guess what. This is not the first time Carnival had problems with fires in the engine area.  

According to the processes in SMS, which we are all very familiar with, analysis of all incidents, hazards and accidents must be done in order to come up with elimination or mitigation of the root causes to prevent these from happening again. Well, here we have another case of ignoring the “Variations” that have occurred in order to continually improve the system to prevent these incidents from reoccurring. 

In addition, in performing a bow-tie diagram, you could have figured out what would be the best decision to make after the fire and power outages to reduce the impact to the passengers and crew. What do we do if the bathrooms don’t work? How do we feed everybody in an orderly manner? How to we handle special need customers? Do we have a plan to get the passengers off the ship as soon as possible? These and many other questions should have been resolved BEFORE the incident takes place. 

Some questions come to mind while reading about this event : Why didn’t they seek to dock or tender the ship as soon as possible to reduce impact on the passengers. The cost of that would certainly be less then the fallout now. The ship passed several ports in Mexico in those 5 extra days. Also, the passengers had a hard time in getting meals. There was no procedure that could have formalized that processes to ease stress. Also, could there have been a contingency plan to mitigate the sewage problem in a more sanitized way then bags and buckets? Just a few thoughts that come to mind. 

Of course the best scenario is to PREVENT the incident from happening to begin with. Process Identification, then Analysis followed by Process Improvement. All of this could have been prioritized through Risk Assessment. 

THE LESSON: Unfortunately Carnival Cruise lines will know what the cost of this event will be. You can guess it will not be cheap and deeply impact on the company’s financial health. Not to mention the loss in future customer loyalty. That will be the biggest fallout from this incident. ..........Your thoughts

There’s Something Fishy about Cause and Effect!

I always refer to Fishbone diagram as the most widely used Root Cause Analysis tool in the world today. That is a hefty title but, I can state this with confidence. The Fishbone diagram is definitely one of the Basic tools of Quality. The Fishbone Diagram was created by Kaoru Ishikawa in the 1960s, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. 

Common uses of the Ishikawa diagram are product design and quality defect prevention, to identify potential factors causing an overall effect. Each cause or reason for imperfection is a source of variation. Causes are usually grouped into major categories to identify these sources of variation. The categories typically include:

• People: Anyone involved with the process
• Methods: How the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and laws
• Machines: Any equipment, computers, tools, etc. required to accomplish the job
• Materials: Raw materials, parts, pens, paper, etc. used to produce the final product
• Measurements: Data generated from the process that are used to evaluate its quality
• Environment: The conditions, such as location, time, temperature, and culture in which the process operates

(NOTE: The categories where derived by Dr. W.Edwards Deming. I consider measurement to be an output but Dr. Deming states, “The way we measure a process has an effect on the output..” from Out of the Crisis by Dr. W. Edwards Deming, 1982.)

How to create a Fishbone diagram:

Select the most appropriate cause & effect format. There are two major formats: 

The Dispersion Analysis Type is constructed by placing individual causes within each “major” cause, category and then asking of each individual cause “Why does this cause (dispersion) happen?” This question is repeated for the next level of detail until the team runs out of causes. The graphic examples shown in Step 3 of this tool section are based on this format. 

Cause and 

The Process Classification Type uses the major steps of the process in place of the major cause categories. The root cause questioning process is the same as the Dispersion Analysis Type. 

2. Generate the causes needed to build a Cause & Effect Diagram. Choose one method: 

-Brainstorming without previous preparation 

-Check Sheets based on data collected by team members before the meeting 

3. Construct the Cause & Effect/Fishbone Diagram. 

a) Place the problem statement in a box on the righthand side of the writing surface. 

Allow plenty of space. Use a flipchart sheet, butcher paper, or a large white board. A paper surface is preferred to allow the final Cause & Effect Diagram to be moved. 

b) Draw major cause categories or steps in the production or service process. Connect them to the “backbone” of the fishbone chart. 

Be flexible in the major cause “bones” that are used. In a Production Process the traditional categories are Machines (equipment), Methods (how work is done), Materials (components or raw materials), and People (the human element). In a Service Process the traditional methods are Policies (higher-level decision rules), Procedures (steps in a task), Plant (equipment and space), and People. In both types of processes, Environment (buildings, logistics, and space), and Measurement (calibration and data collection) are also frequently used. There is no perfect set or number of categories. Make them fit the problem. 

The example above uses the six most common major spines used in Quality Assurance diagnosing. 

c) Place the brainstormed or data-based causes in the appropriate category. 

In brainstorming, possible causes can be placed in a major cause category as each is generated or only after the entire list has been created. Either works well, but brainstorming the whole list first maintains the creative flow of ideas without being constrained by the major cause categories or where the ideas fit in each “bone.” 

Some causes seem to fit in more than one category. Ideally each cause should be in only one category, but some of the “people” causes may legitimately belong in two places. Place them in both categories and see how they work out in the end. 

#If ideas are slow in coming, use the major cause categories as catalysts (e.g., “What in ‘materials’ is causing . . . ?”). 

d) Ask repeatedly of each cause listed on the “bones,” either: 

“Why does it happen “ For example, under “Securing hardware old”, this question would lead to more basic causes such as “missing straps”, “tools missing”, and so on.

Once you have exhausted all of the possible causes, the team will use another tools, which I will discuss on future blogs,  to help narrow the causes down to one, two or three that will be worked on to mitigate or eliminate. Most of the information on Root Cause Analysis comes from the Safety Management System Memory Jogger II written by Sol and Dennis Taboada. Available at dtitraining.com 


Your thoughts...

SMS – a tool beyond the trial and error method

Safety Management System (SMS) is the new way of manage safety and  improve safety in aviation. After major accidents, great safety improvements were implemented.  Some of these accidents which created improvement to safety were the Tenerife Airport disaster including two Boeing 747, Linate Airport crash between a MD-87 and Cessna Citation, Los Angeles Airport when a Booing 737 overran a Metroliner and a mid-air collision with Aeromexico and a PA-28. From these and other disasters came great safety improvements as crew resource management, ground radar, standardized phraseology and introduction of runway status lights.  

Aviation safety has now risen above and beyond these 100 year of aviation trial and error method, to a system where there is zero tolerance to compromise aviation safety. We do no longer accept accidents as a tool to improve safety. 

Accidents happens in the way we do things. Nobody comes to work one morning planning to have an accident. They come to work to do their job the way they are trained and the way they are expected to by their supervisors and the organization they work for. 

A safe flight begins and ends at an airport. The airport operator has to manage time and place to avoid runway incursions, the airline has to manage crew and equipment to support operations and the pilots have to manage information and technical operations to ensure safe flight. 

SMS starts at the top level in the organization, with the accountable executive (AE). An AE is the CEO, President or Owner of the organization, or someone else who has final control of financial and human resources. The AE must make a firm commitment to safety and approve the safety policy. Accountability is to operate with zero tolerance to compromise aviation safety. This must be clearly identified in the safety policy, and clearly supported by the AE. Accountability must trickle down the organization to accountable management and accountable employees. To allow for organizational accountability, the organization must operate in a just culture and integrate a clear commitment to a non-punitive policy in SMS. 

Simplified, SMS is to identify, document, analyze, decide action, implement and review of hazards, incidents and accidents. A hazard is an item or process which could lead to an incident or accident. An incident is the happening of an un-planned event, or developed hazard,  which caused interruption of time. An accident is an incident which caused loss of property, human life or hospitalization of personnel.    

All processes in SMS are dependant on interpretation and action by people. Without people involved a process becomes void and can not function on its own. People applies their understanding of the process based on knowledge level, training, emotional factors and environmental factors. Therefore, the organization must tailor processes to personnel who are intended to carry out the process. It is not possible for SMS to perform effectively if processes becomes mass-mail and one-fits-all.

There are several methods available to evaluate the effectiveness of SMS, from Statistical Process Control (SPC), surveys, observations and communication. If there is one question to ask the AE to find out how solid and effective SMS is in that organization, it would be “How many hazard reports have you submitted this month”?

Submitted by – farnorthaviation