Lessons in Six-Sigma Quality Control for Compliance The greatest sources of inspiration are often found in the strangest places. Thus, compliance management can take a lesson from lunchtime in Mumbai, where a Briggs Every day in Mumbai, the biggest city in India and one of the largest in the world, a cadre of barefoot, semi-literate lunch deliverymen and a very few women called dabbawalas deliver a few hundred thousand hot, home-prepared lunches to office-bound workers all over the congested city.
Does FDA look at and trend product liability litigation for food, drugs, medical devices, cosmetics, etc. The FDA is not blind to reality. If people, through product liability litigation, are having to take matters into their own hands to go after companies for putting ineffective or unsafe products on the market, FDA could be seen as not performing its task.
So yes, FDA pays very close attention to product liability litigation. How does an FDA investigator prepare for an inspection? Prior to an inspection, the investigator s will create an inspection plan that is largely based on the following information: Consumer complaints that have come in since the last inspection Adverse events that have come in since the last inspection Any recalls or other field activities that have occurred since the last inspection Any product submissions and applications, specifically to find critical components or ingredients or processes that were of concern to FDA reviewers Online research through the web.
Online web research can be further Case 2 quality compliance at the into three main areas: FDA investigators treat a closeout or follow-up inspection as a normal inspection. You can be cited for new or additional items.
FDA reviewers of a submission will identify areas of concern for the investigator to look at during the inspection such as GCP data integrity controls.
PAI inspections may cover everything from nonclinical supporting GLP-compliance, through GCP compliance, to GMP compliance, and even delve into how the company will monitor and control the product once it is approved and on the market.
Thus, 21 CFR 11 controls will be reviewed and inspected throughout the PAI, not just during review of the design and development e.
Will FDA investigators ask for supplier audit reports? That said, by internal policy, FDA discourages investigators from asking for the report in the hopes that this will encourage firms to be more candid and clear in supplier audits.
This last point is often overlooked. How does computer validation play into regular inspections? Part 11 will come up throughout an inspection as it is a regulation that cuts across all quality system subsystems.
If records are used or kept in digital form, or if a computerized system is used to automate a regulated process such as production, lab testing, etc.
FDA looks to see if you are verifying the functions that you use of a software or a computerized system in your environment, especially those functions related to data integrity. Do not validate Excel, just the use of the macro within your environment.
Questions that the FDA investigator might ask include: How do you know the results of the macro are correct? Did not drop off various data inputs?
These types of Part 11 validation are the ones to concentrate on. FDA treats all photographs, videos, documents, notes, etc. All such items go through FOIA to redact such sensitive information before they are released. Then, in your response to the inspection, make sure to identify the photograph and any specific confidential or trade secret information that may have inadvertently been captured by the FDA photograph.
This will help FDA to redact the appropriate information while providing you some degree of assurance that they understand and acknowledge the situation. However, FDA is currently not positioned to take advantage of this.
The agency is planning to start a pilot program wherein part of the inspection will be conducted remotely e. Keep in mind that at its core, FDA is a regulatory enforcement agency.
As such, during inspections, it is technically collecting evidence. For companies doing all the right things, it is in their interest to have FDA investigators physically visit and see firsthand how well the company is doing. FDA is well aware of this.
In order to address this, expect FDA over the next few years, to take a two-step approach to an inspection: Management discussion items are non-compliance observations not written onto the Form FDA Management discussion items are compliance deviations that the FDA investigator believes to be of lesser significance than the documented s.
However… Management discussion items can still end up as warning letter citations because the FDA district office or FDA head office believes they are more serious than originally assumed. Thus, if you address management discussion items in your response to FDA, you may want to notify the district that you are working to resolve the items as well as the written observations.
Finally, be aware that management discussion items can be treated as repeat violations if found again in a follow-up or a second FDA inspection.A qualified Risk, Quality and Compliance Professional with +10 years of work experience within the public and private sector industries of Manufacturing, Engineering, Community Care, Consulting Environments and Facilities Management with a focus on improving business efficiency and ensuring compliance to local & international standards and relevant laws & legislations.
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CASE STUDY SEMINAR TWO 1 Quality Compliance at the Hawthorn Arms Andrea Conklin Baker College, HRM B, Dr.
Bob Goldwasser October 8, This preview has intentionally blurred sections. Sign up to view the full version%(14). 2 Introduction: The Case for Compliance The ultimate mission of every college and university is to create and communicate human creativity and knowledge through research, teaching, and free.