•  laziness – personnel do not take the time to reference the procedure
• lack of understanding – personnel do not understand the imporance of their role in the process or the importance of referencing and following procedures as written
• ego – personnel believe they know a better way or believe that they are so familiar with the task that they do not need to reference the procedure
• poor morale – personnel simply do not care about the product or do not feel that they can make a difference

This failure mode goes hand in hand with “good intentions/ego”.

5 whys analysis

Every one of these failure modes is a management failure.  It is management’s responsibility to promote quality throughout the organization.  That includes teaching personnel about the value of their role in the process and the foreseeable impact of failure to follow procedures.  Management is responsible for ensuring that personnel are knowlegeable about the work they perform.  Management is also responsible for remediating situations and attitudes that jeopardize quality. 

If you are a manager and you have observed tendencies described in this post by your direct reports, you need to examine what you can do differently to affect a different outcome with your staff.   Preventive action for root causes of management failure must be assigned to executive management personnel having the authority to commit resources and command resolution.  Failures in leadership are problems that usually can only be resolved from the top down because they generally require management committment, management authority and the ability to allocate financial resources.

Part 1 of this blog series introduced 5 common causes for personnel failure to follow procedures.   This installment of the series will discuss failure modes and possible resolutions for the  Problem Statement: The SOP was purchased, borrowed, or migrated and does not reflect how the process is actually performed in the location that it is being used. 

The most obvious (and most used)  potential corrective action is to revise the procedure to reflect the manner in which the procedure is actually performed.  However this corrective action does not address how the event happened in the first place or preventing recurrence.   A why-why analysis would identify failure modes for the problem statement, thus enabling the selection of a preventive change.

For any single problem statement  there may be multiple failure modes that need to be investigated and resolved.  In a why- why analysis, for a mismatch between procedure and actual activities performed, the failure modes identified are likely to drill down to one of two prominent root causes:  1.  Failure in Quality Planning or 2. Failure in Leadership.  Failure in quality planning may be a failure in leadership or it may identify area for audit or signal the need for other quality system improvement activity.

why why analysis

(Note: Failures in quality planning and leadership indicate the need for additional internal audits to determine the magnitude of system or leadership problems.)

Preventive actions for root causes of management failure must be assigned to executive management personnel having authority to commit resources and command resolution.   Failures in leadership are problems that usually can only be resolved from the top down because they usually require management commitment, management authority and the ability to allocate financial resources to resolve.

Part 1 of this blog series introduced 5 common causes for personnel failure to follow procedures.   This installment of the series will discuss failure modes and possible resolutions for the  Problem Statement: The SOP describes an ideal process and not the process that is actually performed. 

The most obvious (and most used)  potential corrective action is to revise the procedure to reflect the manner in which the procedure is actually performed.  However, if the change was intentional and management intends for the procedure to be followed as written, revising the procedure to reflect actual practice is not a desirable option.  It is important to realize that the problem may not be that the document is wrong but the problem may be that personnel are not aware of a procedural change or that personnel are simply not following the procedure. It is a good idea to perform the why-why analysis  because it broadens the possible avenues for correcting the problem by identifying the failure modes.

For any single problem statement  there may be multiple failure modes that need to be investigated and resolved.  In a why- why analysis, for a mismatch between procedure and actual activities performed, the failure modes identified are likely to drill down to one of two prominent root causes:  1.  Failure in Quality Planning or 2. Failure in Leadership.  Failure in quality planning may be a failure in leadership or it may identify area for audit or signal the need for other quality system improvement activity.

(Note: Failure in quality planning and leadership indicate the need for additional internal audits to determine the magnitude of the problem.)

After the why-why analysis it is possible to target other avenues such as creating quality documentation,  training, improving personnel accountability, and  improving  management accountability to resolve the actual root cause of the problem.  Corrective actions may be assigned to any competent personnel with the authority and responsibility to take action.  Preventive action for root causes indicating failure in quality planning should be assigned to the head of quality for resolution. Preventive actions for root causes of management failure must be assigned to executive management personnel having authority to commit resources and command resolution.   Failures in leadership are problems that usually can only be resolved from the top down because they usually require management commitment, management authority and the ability to allocate financial resources to resolve.

The Root

The top 5 reasons (in no particular order)  that I have observed for failure to follow SOPs are:

5. The SOP describes an ideal process and not the process that is actually performed

4. The SOP was purchased, borrowed or migrated and does not reflect how the process is actually performed in the location that it is being used

3. Personnel are not motivated to follow a procedure step by step, as written, every single time

2. The process is poorly defined, the procedure is poorly written and personnel are not able to follow it

1. Good intentions/Ego

In my upcoming series of blogs, I will provide a discussion about each of these root causes, possible failure modes and possible corrective actions for each failure mode.

Stay tuned…

For Immediate Release: March 10 2011
Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA, Justice Department take action against McNeil-PPC Inc. 
Charged with manufacturing and distributing OTC drugs in violation of federal law

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Summary:  March 10, 2011 FDA filed a consent decree of permanent injunction against McNeil PPC and the company’s Vice President of Quality and the Vice President of Operations.    The McNeil Consumer Healthcare Division of Johnson and Johnson,  has had numerous and significant manufacturing problems and recalls of children’s Tylenol and other OTC medications over the past year or so.

McNeil is required to retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to perform audits to assess whether corrections have beeen made, violations have been corrected, and that adequate manufacturing processes are in place.

If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually.

Ticalion Commentary:  If up to 10 million annually seems like a big number,  consider Genzyme’s $175 million consent decree or Schering-Plough’s $500 million disgorgement consent decree.  FDA is serious about compliance and is raking in huge fines through consent decree.  There has been a sharp increase in auditing activity and warning letters over the past couple of years.   You can do the math.    If you have been issued a 483 you need to determine  whether you are not in compliance because you have been complacent and inattentive, you don’t have adequate resources or  because you don’t know how to get into compliance.  Be honest with yourself.  If you received the 483 because you have been complacent, get yourself in gear and refocus.  If you received the 483 because you don’t understand the requirements or how to be in compliance, call a professional.  In fact… call me 410-245-7237!    I don’t know of any consultant that would cost as much as a consent decree.