1. How have you shown continual improvement to process performance and product quality over the last year?
Through the use of a variety of diagnostic tools it is possible to demonstrate performance in terms of a snapshot in time and then to trend this over a given period to provide a measurement of how well you are doing both in terms of performance output and quality improvement.
As we work with our client base, we encourage the use of these types of tools which demonstrate areas of strength and weakness and these can then be identified and prioritized in terms of their criticality. Once this is completed, the appropriate resourced can be scheduled to close the gaps between the current state situation and some future state condition which represents a best practice scenario. The important thing here is to put in place proactive measures which will provide a rapid indicator of where the company stands relative to both industry equivalents/ competitors and federal statutes. So one employs both benchmarking tools together with a variety of criticality maps (sometimes referred to as heat maps), which provide a visual representation of the current status snapshot that is readily interpretable without having to focus too intensely on specific numbers which can be misleading.
2. In what ways do you ensure that your quality standards are consistent with your partner’s?
Quality governance and quality decision-making are often at the root of many of the problems that we experience within our industry and we feel that this is an important area that needs to be addressed if one is to truly establish a strong foundational platform on which to build a sustainable quality culture.
It is important that everyone within the organization understands what the quality goals of the organization are so that they can properly align the procedures and practices that they are responsible for on a daily basis, with the policies that form the overall quality policy for the company.
In addressing this area of potential weakness, it is important to focus on establishing more effective mechanisms of communication to assure that the appropriate harmonization of understanding is disseminated amongst all the parties involved.
One way of achieving this that has proven powerful is through the establishment of cross functional quality forums which initiate an appropriate level of dialogue to work through common problems and issues to establish sensible practical workable policies that lend themselves to sustainability. This dialogue may include process mapping, flowcharting and SIPOC (suppliers, inputs, processes, outputs and customers) analysis as these provide valuable information in a clear analytical format that promotes the harmonization of standards, the lifeblood for a successful quality partnership.
In particular, partners at multiple sites can benefit from this type of initiative through the communication of regional requirements that may not be immediately obvious to those involved in creating the corporate policy. This is particularly poignant in relation to globalization situations where the concept of one size fits all never exists.
Inevitably however, the success of these types of initiatives is only borne out provided the parties involved are prepared to have an open exchange of ideas which include challenging existing folklore and current best practices.
3. How has your organization confronted the increasing emphasis on sustainability initiatives?
In reviewing quality system failures with a number of organizations, several have embarked on extensive initiatives to improve their performance metrics through an emphasis on right first time.
Frequently as one looks in more detail at system failures, which can be identified through an FMEA analysis or an Ishikawa (Fishbone) analysis for example, one can determine the root cause of why something is occurring and then develop a rational remediation plan to correct and prevent the situation from occurring again. This should be the basis of all CAPA programs and is the basis of approaches offered by Smart Consulting Group to our clients.
Now through a prioritization process integrated with a lean, process excellence, continuous improvement strategy, we have demonstrated with our clients that it is possible to appropriate resource revolving quality system element requirements so that a more manageable solution becomes possible. Through our experience we frequently find that when a corrective measure requires a significant level of input, the probability for this to break down and result in a recurrence of the problem is high. Where possible, we ensure that complimentary quality system elements such as change management document control, calibration/maintenance and validation have sufficient overlap to assure that their KPIs (key performance indicators) starts to drift then multiple alert signals will be generated before the problem turns critical.
Use of metrics is a prerequisite to achieving compliance sustainability but they must be the right metrics and they must be widely disseminated using a format that is readily interpretable especially at the grassroots level. Communication of metrics generated through performance scorecards is an extremely useful tool to use which may be enhanced using communication boards at strategic points within the workplace.
This is an example of how lean philosophy can be married with compliance measures to generate a lean compliance culture which can have sustainable consequences.
4. What steps have you taken to establish sustainability as a primary focus?
The expectations for regulatory compliance have changed considerably over the way they were 10 years ago and we can expect this to be a continuously evolving process as we develop and commercialize new medical products and therapies. As is true in other industries, there is going to be a need to improve efficiency to remain competitive but this should not be at the expense of what needs to be done to assure quality and safety. So in order to achieve this we need to develop smarter approaches to how are going to tackle these challenges without making our practices cumbersome and uncompetitive. In the past, the role in dealing with severe regulatory compliance situations such as consent decrees and severe warning letters has been to overload the organization with new procedures and practices that nail down every facet that has the potential to be a compliance issue. Whilst this may have been done with great intent, the practical outcome has been that business efficiency declined resources were not being appropriately used in the areas where there was a potential to return the greatest compliance improvement for every dollar spent. Our approach is to generate a criticality matrix for all the compliance gaps that need to be remediated as a result of a GMP assessment/audit and then to selectively position resources that are stage-appropriate for the needs at hand so that there is an appropriate expenditure of effort where there is greatest need. This is all part of the risk analysis approach that must be a part of the quality system analysis in order to avoid situations where issues fall off the plate as a result of the available resources being outstripped by the number of problems requiring those resources. This type of approach is consistent with ICH Q9 and we feel that it provides a solid foundation to assure that resources can be made available on a consistent basis and this contributes to achieving a sustainable compliance scenario.
5. How will sustainability continue to influence the way you conduct business?
Looking at the requirements to be in compliance with GMP’s for the 21st century and the globalization of modern quality practices through the ICH guidelines, it is important that all companies put the foundational bricks in place that will enable them to adjust to the evolving standards and industry practices without damage to their competitiveness.
In a global marketplace where cost and efficiency are going to be prime drivers of competitiveness, resources applied to assuring quality compliance is built into every aspect of the manufacturing operation. These are going to be at a premium meaning the culture and mode of operation must be established to prevent muda (waste) from negatively impacting the overall compliance process.
Standardization of operating practices and in particular standard work is one important mechanism that can assure a higher probability of right first time operations and fewer deviation investigation incidents. For many manufacturing plants this is a very significant source of wasted expenditure, which in a lean environment cannot be tolerated.
A clear understanding of how management processes function is being increasingly harnessed by clients as they seek to improve their overall efficiency, effectiveness and regulatory compliance scorecard. We are advocating the use of SIPOC analyses (suppliers, inputs, processes, outputs and customers), since this provides a focus on customers and customer expectations, which invariably reduces mistakes through misunderstandings in communication.
Communication is a fundamental tool which is often overlooked in terms of its significance in creating a sustainable compliance environment. Some clients use daily meetings at various tier levels to communicate valuable information that is proactive in preventing problems, in addition to using those same meetings to resolve issues that could interrupt production and cause a compliance incident. This again provides a competitive advantage as well as creating the environment for sustainable compliance.
The emphasis therefore is going to be on the adoption of lean/process excellence principles which will decrease compliance incidents and provide the competitive edge for those adopting these approaches to become market leaders for their products.
6. What strategies have been implemented to guarantee GMP compliance at your facilities?
There is never one standalone technique that we employ to guarantee GMP compliance in a pharmaceutical facility. This idea is just not feasible as there are many influences which contribute to success in the GMP arena. One of the most important in our opinion relates to the culture of the organization in relation to its approach to quality.
Due to the changing compliance environment, many experienced practitioners within our industry are being caught up in a culture that is often not current in terms of industry standards and regulatory agency expectations. This frequently leads to a level of complacency which results in regulatory compliance deficiencies and bad results during an FDA inspection. An investment in change management to permanently shift the organizational culture towards one which embraces flexibility, cross functional cooperation and continuous improvement as a daily staple is necessary. This needs to be a senior management directed initiative which is driven through the grassroots organizations within a company since it is often at this grassroots level where the nitty-gritty compliance issues arise during manufacturing processes. Strategies which establish a dynamic dialogue between the FDA and the company through active membership of key industry associations as well as attendance at cosponsored industry agency meetings/conferences/forums, helps to set the foundation for a new agenda rather than being the recipient of someone else’s ideas that might generate unforeseen problems.
Another strategy which we feel is important relates the use of visual management practices which helps to subliminally condition workers at the operational level because there is a much more powerful connection than using the written word between the level of instruction and the task being performed. The old adage that a picture is worth 1,000 words is very true and measurable through the use of appropriate performance metrics and scorecards for key performance indicators (KPIs).
7. Evaluating potential risks for projects is essential in achieving regulatory compliance and overall product safety. What risk management practices does your organization employ?
With the establishment of ICH Q9 as a central part of the compliance landscape, the type of practices that we regularly use tend to follow those that are frequently outlined in FDA documents.
By generating a series of criticality (heat) maps that use red amber and green to signify the level of criticality for the seriousness of the situation, one can establish a harmonized risk assessment and mitigation approach that will provide a satisfactory framework upon which a whole series of related compliance measures can be knitted together to provide a workable, efficient, and reliable strategy. Combining these with the use of performance scorecards (which feed the data into these maps); one has a mechanism to provide an ongoing “living” snapshot at any moment in time.
Inevitably, changes in practices will cause changes in procedures and this may cause conflict if appropriate interference checks are not performed. One way of minimizing this type of risk is to use an integration map that highlights all of the document interdependencies that might otherwise cause some form of potential conflict associated with a compliance implication.
Mentioned earlier, the use of a tier level escalation process has helped a number of companies to ameliorate situations that were previously generating large numbers of deviations. This practice derives from lean philosophy and functions through the use of cross functional team representatives meeting daily prior to the start of manufacturing operations. At these meetings observations are raised and issues that may be the potential for a compliance incident are discussed, resolved and implemented. This preventive proactive measure is extremely cost-effective and neutralizes potential compliance situations before they arise. All of these elements can be tracked and trended using appropriate scorecard metrics. Situations that are not resolvable are escalated to a similar manager level meeting at midday, at which point a directive is agreed upon between manufacturing tech services and quality in relation to the best course of action to take. Failure to resolve at this level sends the issue to the executive site management level that same day whereupon senior management directives provide the new forward strategy. In our experience, this has proven extremely effective and very popular with both operational and quality staff with the added benefit of building cross functional cooperation which is essential for sustainable compliance.