Quantifying Quality
Quantifying Quality
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 which 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”:
• Number of successful external and internal audits as a percentage of the total number of external and internal audits: the higher the percentage of successful external audits (e.g., by existing/potential clients, regulators), especially when you have a large number of them, the better your “quality.” Passing one audit with flying colors is great but passing multiple audits with few minor or no observations is way better. It not only sets a trend regarding “legitimate” quality but it also validates the company’s degree of quality from different perspectives. This scenario allows any company to claim that its quality system has withstood scrutiny from a variety of companies and/or regulatory agencies over a long period of time.
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.
Measurements for Success
• Number of “directed” (i.e., “for cause”) audits as a percentage of total audits: because directed audits are performed to follow up on actual or perceived regulatory compliance problems, the higher the number of “directed” audits, the more questions will be raised about your “quality.” “Directed” audits could be external (i.e., performed by existing clients or regulatory authorities) or internal (i.e., performed by internal quality staff). The higher the number of problems confirmed, the weaker the quality system. Even if these types of audits indicate in general that there are no actual problems, or a minimal number of problems, a large number of such audits should prompt questions regarding why the perception exists that the degree of “quality” is such that an investigation is required.
Number of Investigations
• Number of repeating issues as a percentage of the number of audits performed: repeating issues are symptomatic of a quality system that does not correct or otherwise effectively address problems. While isolated incidents are not necessarily a reflection on the company’s overall quality, incidents that span multiple project teams and/or departments and/or are observed more than once may be indicative of quality-related problems. It is very difficult to convince anyone of the quality of operations when problems that are systemic in nature become evident.
The higher the percentage of audits that contain repeating issues, the more likely that this may be viewed as 1) management indifference, 2) lack of management involvement, 3) inappropriateness of personnel qualifications and/or 4) inability/unwillingness to invest in “quality.”
Lost Business
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”:
• Regulatory compliance decisions that are not defined in writing and/or are not defensible.
• Cumbersome and inflexible procedures that require more resources than necessary to execute them without “procedural deviations.”
• Inefficient procedures that require the same activity to be done more than once in order to be in compliance.
• Ineffective procedures that do not reach the desired objective of being in compliance after the first execution.
• Unclear procedures that result in too many on-going corrections in order to inject “quality” into operations.
• Too many procedures that company staff must follow without any value added.
• Contradictory procedures that lead to generating Notes-To-File, CAPAs, deviations, investigations, etc. because compliance to one procedure results in non-compliance with one or more other procedures.
The Costs and Benefits of Quality
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 and Len Grunbaum
Partners of The Practical Solutions Group, LLC
609.683.0756
Practical Solutions
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In News from FDA: Yet another weight loss danger in Japanese “rapid weight loss” pills. Read the story: foodconsumer.org
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FDA 483s: Effective Responses to Avoid Warning Letters
October 16, 2011Effective Responses to Form FDA 483
Guest Commentary: One Way to Avoid a Warning Letter … Maybe
The following sentence fragments represent but a very small sample of trumpet calls heralding that a firm may have fumbled an opportunity to avoid a Warning Letter after receiving an FDA-483:
• “We have reviewed your response and have concluded that it is not adequate because…”
• “The adequacy of the response cannot be determined because the response did not include…”
• “Your response does not address…”
• “We have reviewed your firm’s response and note that it lacks sufficient corrective actions regarding…”
• “We have reviewed your firm’s responses; however we continue to have concerns related to your firm’s compliance…”
• “The adequacy of your firm’s response cannot be determined at this time…”
• “Your response is inadequate because…”
We say this because of the following: while a response to an FDA-483 is not mandatory and does not represent a final Agency determination regarding firm’s compliance, a firm’s voluntary response often does impact the Agency’s conclusion of the need for follow-up actions, one of which may be the much feared and dreaded Warning Letter. How so, you ask? Here is how….
"FDA will conduct a detailed review"
This brings us to the quality of the response itself. In this context, the higher the “quality” of the response, the more likely the FDA will consider the response as “adequate” and, as a result, may not issue a Warning Letter. Since the firm’s management controls the quality and timeliness of everything that goes on, we suggest that the following guidelines be used to craft the response to the FDA-483 to increase the firm’s chances of avoiding the Warning Letter:
• Train the individuals involved in the FDA-483 response effort regarding what information should be included in the response and the format chosen to present the response.
• Assign someone to review recent FDA Warning Letters to identify those items where the FDA indicates that the response to the respective FDA-483 was not adequate and include these items in the training to ensure that known mistakes/failures are not repeated.
Focus Your Response
• Establish the true root cause of the observation. In doing so, look for the operational gap (e.g., inefficient project management oversight) that resulted in the regulatory deficiency (e.g., lack of timely document reviews and/or approvals) so that it can be fixed properly and permanently.
• Provide specifics regarding any corrective actions taken or proposed. It is not adequate to state that the problem was or will be corrected. Details regarding 1) what was/will be corrected (e.g., development of a remediation plan), 2) when it was/will be completed and 3) if applicable, the timeframe for training (e.g., as in case of a revised procedure) should be provided.
• Describe preventive actions that will minimize or eliminate the chance of recurrence of the problem in the future.
• Provide supporting documentation for every claim made.
• Show commitment regarding implementing all of the proposed activities by 1) specifying activities to be taken and target dates for their completion, 2) assigning accountability for the actions, 3) ensuring proper completion of each respective activity though internal audits.
The Importance of a Quality Response to FDA 483s
The firm can request that its FDA-483 response be published along with the FDA-483 itself, in which case the response should be such that it gives confidence not only to the FDA but also, where applicable, to existing and potential clients, that non-conformities have not and do not impact data integrity.
The bottom line is this: Do not ever get yourself in trouble with the FDA. But if you do, avoid unforced errors by 1) taking the time and making the effort to respond to the FDA-483, if you get one, in a timely fashion, 2) using the guidelines above in doing so, or 3) consulting with an expert to assist.
By Emma Barsky and Len Grunbaum, the partners of The Practical Solutions Group, LLC
Contact Emma & Len
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ExL Pharma has announced that FDA’s Dr. Leslie Ball will give the Keynote Address at the 2nd annual Developing CAPAs in the GCP Environment conference held 19-20 January in Arlington, VA. GxP Perspectives is a media sponsor.
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Read FDA Warning Letters A suggested practice is to search Warning Letters by topic or issuing office. Then sort by “Letter Issue Date – Desc” to find the most recent Warning Letters.
19 October 2011 update: FDA posted a Warning Letter to SmithKline Beecham (GSK), West Sussex, UK for serious cGMP violations stating: “Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.”
Read the Warning Letter
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On The Blogroll: Rebar Interactive (twitter: @rebarinte) has an excellent blog for clinical sites. If nothing else you MUST check out their post on:
“Patient Recruitment: Think That You Might Be Wrong,”
if for nothing else than the photo. A great blog post by Rahlyn.
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