External - Internal Audits (EIAs)

Quality Management principles and ISO Quality standards all talk about the critical importance of Internal Audit. If you don’t go through the active process of seeking information, then it is impossible to make informed decisions on progress and strategic planning. In the absence of internal audits one cannot use the term “continual improvement” because the word itself implies that you are actually aware of areas that need improvement.

I think that it is of value to talk about two different types of internal audits: one being where you do the assessments in your own organization (let’s call that a true internal audit) and the other is where you hire a consultant or colleague to come and do it for you. I think the term External-Internal Audit has value to describe this latter situation. Both approaches have value and both can provide useful information, but the latter (an EIA) may have greater cost but is more likely to raise critical information based on the knowledge and expertise of the person brought in to do the assessment.

I have mentioned in the past my strong preference on voluntary quality and EIA are another manifestation of that voluntary quality. The information may be done by an outside person, but the information is intended for internal consumption only.

I raise this because I am in the middle of an EIA in a mature and academically oriented laboratory in Canada. I am looking at the structure and function of the laboratory's quality system. It is a rather global review and we are taking our time to do it right so that they will end up with credible and useful information.

A question arose during the post-assessment discussion today about what is intended by the term “top management”. There was general understanding that TM means the folks who are in a position to make decisions for change based on their ability to make decisions on resources (also known as “the pursestrings”). I don’t think that is a correct understanding and in the public sector would almost assuredly be a terrible definition to envision or try to put into practice. The public sector by design is multi-layered with fiscal decisions being made at or very near the top. Almost assuredly the folks at that level are so removed from clinical or laboratory reality which again is by intent to reduce the risk of bias playing a role in fiscal decisions.

A more functional definition of TM (can we call them the function top management or FTM?) is that small group of people who are close enough to have an understanding of the organization’s mission and have the responsibility and authority to make decisions and change taking in mind all the resources available which may or may not include money. This is a really important group that when working well because they are high enough up on the food chain that they can think about the global organization, but are close enough that they can effect change at the local unit. It is a really good example of “Thinking Globally but Acting Locally”.)

Waiting for money to affect change is never a good idea. Positive assertive actions will begat money with a higher and sooner level of success than money will begat positive actions.

Updated for grammar September 2013