Engaged. Knowledge. Application
Is Your Executive Management Team as Involved with the Quality System as they should be?
We’ve all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two Warning Letters issued to date in 2011 with observations related to this area. While there are 26 references related to the role of executive management within the Quality System Regulation (QSR 21 CFR 820), these Warning Letters addressed two basic requirements of quality systems:
· “Failure of management with executive responsibility to adequately ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, the Quality Policy has not been established by any member of executive management ….”
· “Failure to establish and maintain procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).”
In most organizations, the company quality policy is derived by the executive management team and signed by the CEO or President of the company, along with the Head of Quality. The quality policy is then widely distributed to all employees with appropriate explanation to understand the intent and purpose of the policy. Additionally, the quality policy must be measurable and reviewed for adequacy as part of the management review.
The point is, NOW is the time to step back and re-evaluate the role your executive management team is playing in your own quality system. Here are some points to consider:
· When was the last time you reviewed and discussed the adequacy of your organization’s quality policy? Is this documented?
· How effective is your management review process? Do you provide data for data sake? Or are you providing appropriate analysis to help executives be more aware of product and process quality, so they can make more effective business decisions?
· When was the last time you reviewed with management executive responsibilities in the QSR and performed a gap assessment of your system against requirements?
· Can you ensure that you could provide adequate evidence that the executive management team is actively involved with the quality system?
Take a few minutes and evaluate your own system now. It may save you the agony of a Warning Letter in the future. Quality is not hard – It’s just good business.
About the Author
B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small start up companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com
For GMP, GCP and GLP Training Content, please visit the FDA compliance learning community of enKap at: http://www.enkap.com
Views: 3
Comment
Contact enKap
enKap Terms and Conditions
enKap Terms and Conditions
All sales are final
Legal Disclaimer
This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.
© copyright 2012 enKap
© 2012 Created by enKap.
You need to be a member of enKap community to add comments!
Join enKap community