Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO and QSR standards is a sure means for organizations in the regulated industries to keep the costs of noncompliance down, as well as in helping to meet customer requirements and ensure control over their suppliers and the regulations.
This requirement assumes greater significance when the fact that the suppliers are exempt from the jurisdiction of both the FDA and the Notified Bodies in the EU is taken into consideration. It is only over the organizations that use suppliers that these agencies have authority. So, it is entirely up to the organizations in the regulated industries to ensure that they meet the criteria set out in these regulations and that they conform to the supplier qualification and assessment criteria. It is entirely their responsibility to ensure that they have sufficient control over the processes that go into supplier management. The core of this arrangement between the organization and the supplier is risk management, which is a very critical mitigation tool in the supplier management system.
Expected in all stages of the QSR and ISO
Given that the full burden of ensuring supplier control rests on the organization; the latter has to ensure that it selects the supplier who is capable of thoroughly meeting the requirements set out by the regulatory agencies, on behalf of the organization. The supplier needs to be able to meet supplier qualification and assessment in accordance with the regulations set out by the QSR and ISO standards. However, contrary to popular belief, it is not necessary to spend a lot of money to ensure this. As many examples have shown, organizations can show compliance with ease with limited expenditure. How are they able do this?
A seminar on putting a compliant supplier management system in place
This is the essence of the learning from a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. This seminar will impart the skill and knowledge needed for putting in place a supplier management system that is both compliant with the ISO and QSR requirements and is yet cost-effective.
Jeff Kasoff, who is Director of Regulatory Affairs at Life-Tech, Inc., will be the Director of this seminar. Jeff has spent over 30 years in quality and regulatory management, during the course of which he has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startups to those with more than $100 million in revenue. Please register for this seminar by logging on to The importance of meeting Supplier Management criteria. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Complying with both QSR regulations and ISO standards
Jeff will help participants of this seminar gain insights and knowledge of how to accomplish their supplier qualification and assessment that meet both the QSR regulations and ISO standards in a cost effective manner. In his review of the QSR and ISO requirements for supplier evaluation; Jeff will give a definition of the types of suppliers that require evaluation. He will also describe the QSR/ISO requirements for supplier assessment.
Considering the inescapable link between risk management and supplier qualification and assessment, the Director will show how to implement a risk management plan that is effective and will help participants to add value.
Discussion on the core areas of supplier management
Jeff will devote considerable attention to supplier nonconformance, a critical area of supplier management. He will put participants at ease with the ways of how and when to issue the Supplier Corrective Action Request, a highly detested action. Before it gets issued, all the options need to be exhausted. Jeff will show which these are, as well as the knack of handling supplier nonconformance adroitly. While highlighting the importance of collaboration in the approach towards suppliers; he will explain the kinds of behaviors that risk alienating or losing suppliers.
While putting in place a supplier management and system that meet all required regulations and guidance documents is imperative to all businesses; it is more so for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. By default, this system makes dependence on suppliers inevitable.
Yet, having in place a system which ensures that they have sufficient control over their suppliers, as well as to assure auditors and regulatory agencies that the product is safe and meets all the quality requirements, is a must for organizations. Jeff will show how this can be achieved. Ensuring the cost-effectiveness of the compliant supplier management program is very important. Not doing so eats into the gains of compliance and being in control. Jeff will teach ways by which this scenario can be avoided.