In many organizations, quality activities are carried out at a slower pace than other activities. Here are some reasons why.
Quality activities are under-funded because other investments are more attractive – There are typically three types of spending (1):
- (High risk) projects that if successful will be financial blockbusters. Example, research for a new tumor marker.
- (Bread and butter) projects that have a known return. Example, a new MRI machine.
- Quality and maintenance projects. Example, performing an FMEA to prevent medical errors.
Given the financial challenge facing hospitals, a quality type project is not as attractive financially as a # 1 or # 2 project. One cannot advertise the absence of medical errors – customers expect this. The rationale to spend any money is both to comply with regulations and to ensure that enough quality is in place to prevent errors and the resulting financial losses that would follow.
It’s not what most people signed up for – In medical diagnostic companies, engineers and scientists enjoy designing and building things. Focusing on quality activities is perceived as a diversion from design. In hospitals, clinicians sign up to treat patients and or to do research.
It’s often perceived to be adversarial – In diagnostic companies and hospitals, people don’t like to be audited as it is often perceived as an adversarial task.
It can require excessive documentation – Quality activities are at times driven by having to prove to inspectors that certain tasks has been performed. Often the inspectors rely on the site to produce documentation, which by itself doesn’t guarantee quality (2).
It can be confused with certification or accreditation – Passing certification or accreditation is necessary for many organizations to operate, but certification and accreditation don’t guarantee freedom from error. Other quality activities may be neglected because limited resources are devoted to certification and accreditation.
Management commitment is lacking – When management commitment to quality is lacking (e.g., management is faking it), people realize this quickly and pay less attention to quality activities. For example, a high level quality position is assigned to a second rate manager, or pressure is applied to release a product which has not met quality targets.
Are these problems present at your institution? – They may be if any of the following situations arise when trying to implement a quality project (3):
- Great idea – let’s do it on the next project
- But our situation is different
- It will take too long / is too expensive / is too complicated
The solution – There is no easy solution; however, by recognizing the above situations and pointing them out whenever possible, improvements in the climate that facilitate more focus on quality are possible.
- Krouwer JS Assay Development and Evaluation: A Manufacturer’s Perspective., AACC Press, Washington DC, 2002, pp 29-30.
- Krouwer JS ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43.
- Krouwer JS Assay Development and Evaluation: A Manufacturer’s Perspective., AACC Press, Washington DC, 2002, pp 7-15.