GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development, manufacture, and distribution of health products such as drugs, medical devices, and biologics.
In its simplest form, the definition of "quality" is "how good something is." But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and provide little or no guidance regarding how they should be implemented?
In light of this, we would like to offer some ideas regarding how to measure - quantify - how good your "quality" is in tangible and practical terms. We contend that such metrics are useful in order for company management to make sound decisions regarding whether and/or where the quality system (i.e., the operational infrastructure that promotes and facilitates "quality") requires improvement. The following key indicators are not all-inclusive (nor are the items mutually exclusive), but they provide meaningful ways to assess your "quality":
While "looking good" to the outsiders is great, "feeling good" about what is under the covers is even better. Therefore, if thorough internal audits do not find any issues that either directly (critical observation) or indirectly (major observation) impact subject/consumer safety and/or data/product integrity, then "quality" is inherent to the operations.
You may wonder how a subjective term like "success" is defined in this context. Fair question. A result of "no audit findings" (e.g., no FDA 483s, no audit observations) is the clearest measure of success. A relative handful of "minor/cosmetic" issues is not perfect but is certainly acceptable in this context. To the extent that the number of observations may be "critical" or "major," as defined above, the audit will certainly be viewed as less successful or even unsuccessful. One should also remember that it is a common thing in the industry to consider a large number of minor observations as a major issue because this scenario gives an impression of a negative trend, the latter of which is not conducive to having quality operations.
In addition to the items listed above, there is another important quantifiable component to "quality," which is too often being overlooked or not being considered at all. This component is what we define as "the monetary expenditure associated with 'quality.'" Namely, we are talking about an operationally quantifiable parameter - cost of establishing and maintaining "quality" operations. Most will argue that "quality" is very expensive no matter what. We firmly believe that it does not have to be that way if the underlying causes, which directly and unnecessarily contribute to the extra cost of doing business, are either eliminated or minimized. Here are a few examples to give you a flavor of what can contribute to increased costs when it comes to meeting the regulatory responsibility of instituting and sustaining "quality":
The above-listed activities not only translate into the need to spend more time and money in an attempt to have operational quality, but a number of these items translate into further quality-related costs to the company. Examples of the latter include, but are not necessarily limited to, taking the time to respond to observations or even worse yet, an FDA-483 or a Warning Letter. We think the point we are trying to make is clear....
Our bottom line is that you can make both your QA and CFO happy by quantifying "quality" in terms that will be understood and appreciated by both. This means that sound decisions can be made regarding whether and/or where to apply precious company time and resources help ensure that your "quality" is as good as it can be without putting the business out of business.
Emma Barsky has over twenty-three (23) years of broad pharmaceutical experience in various areas ofclinical and commercial QA/QC; outsourcing; project management and technical chemistry; andmanufacturing and controls (CMC)-related operations. This forms the basis for her vast knowledge of the regulations and regulatory compliance for life science companies.
Since the launching of PSG, Ms. Barsky has leveraged her expertise to 1) conduct due diligence audits, 2)perform multiple operational, quality and computer system validation assessments, 3) develop andimplement regulatory compliance and operational strategies, 4) conduct field and fraud investigations, 5) help companies to either build or enhance their quality infrastructure in order to successfully pass customer audits and regulatory authority inspections, 6) host customer and regulatory agency inspections and 7)manage multiple projects that required the assistance of subcontractors.
Len Grunbaum has more than forty (40) years of experience as a business systems analyst, computer systems analyst and programmer, EDP audit and quality assurance professional and consultant. He is a recognized expert in the pharmaceutical industry, particularly in the areas of computerized systems; IT infrastructure; electronic records; regulatory training and the operations that support them; computer system validation; quality assurance; and compliance with 21 CFR part 11. He has written extensively on these subjects, won awards for best article, and has delivered numerous tutorials and training sessions to customers and industry groups. He has also provided compliance enforcement training to the FDA; helped to build quality infrastructures for life science companies and organizations that support them; prepared companies for customer audits and regulatory authority inspections; hosted customer audits and regulatory authority inspections; and was asked to assist with field and fraud investigations.
Mr. Grunbaum was involved in organizational effectiveness; operational design; business process management; and computer systems design/development in the insurance and financial services industries. He designed a computer auditing model for the New Jersey practice of KPMG Peat Marwick. He also managed the computer auditing efforts for a major practice office of Coopers & Lybrand (now PriceWaterhouseCoopers), including all offshore activities in support of a major pharmaceutical customer.