The ingredients of a truly effective internal audit program

 

AFirst Sliden internal audit program of an organization’s Quality Management Systems is a core requirement from both the ISO and the FDA. At its barest, an internal audit system can be understood to be an assessment or inspection of an organization’s Quality System. Audits are a very beneficial and positive tool for continually ensuring that an organization’s internal management systems are up to the mark and keep meeting regulatory requirements on a consistent basis.

An internal audit program is the most effective and useful tool in helping an organization discover its loopholes and deficiencies in the Quality System, which is absolutely essential to help it pass regulatory hurdles. The purposes of an internal audit, as set out by ISO 9001, which describes Quality Management Systems audits, are to ensure that:

  • The Quality Systems of the organization comply with the requirements of ISO 9001 and its latest versions
  • They show compliance with the requirements of other regulatory bodies such as the FDA
  • They comply with the quality requirements the organization has
  • The organization makes effective implementation and maintenance of the QMS.

ISO 9001 does not require the internal audit procedure to be fully documented. An organization has to only, to use the ISO’s own words, “maintain an audit program” and retain the documents relating to the audit and its results and information contained in them.

Multifold benefits of auditing

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Auditing, both external and internal, bring many benefits. Besides meeting the purposes as set out by ISO 9001 and others such as the FDA; auditing helps organizations:

  • Identify the areas in which they need to make improvements
  • Apply best practice relevant to the particular industry
  • Take preventive actions that could nip potential problems in the bud
  • Ensure greater customer satisfaction.

Compliance with audit requirements is considered drudgery

Despite the noble intentions behind internal and external audits; three fourths of organizations consider audits as being very cumbersome, unpleasant and baneful. Most of them carry out audits with no conviction. They carry them out only because they have no other choice. Most businesses fail to see the value behind the efforts needed for carrying out audits that meet regulatory requirements.

Carrying out audits without any sense of purpose results in more drudgery and unpleasantness. The result of carrying out audits for the sake of it, rather than with purpose is there to see: More Warning Letters, 483’s, penalties and other actions such as even Consent Decree, from the FDA.

Learn to carry out effective audits more willingly and effectively

The ways by which organizations can overcome the mental barrier to carrying out audits and put in place a well-planned, compliant audit program that reduces the risk of noncompliance will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulated industries, will be offering.

Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the Director of this seminar. To enroll for this webinar and gain complete understanding of the means for planning and implementing a Quality Systems audit that meets regulatory requirements,

Please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900854SEMINAR?wordpress_SEO. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete understanding of the rationale and ways of carrying out compliant audits

This seminar will be highly useful in helping audit professionals in organizations devise an effective audit program with is compliant. It will put participants on the path to a thorough quality audit program that meets regulatory requirements. Such a well devised quality audit program is a powerful tool in helping organizations to understand, reduce and communicate risks relating to quality and compliance.

Susanne will open the participants’ minds to continuous improvement, which starts with the awareness of issues and opportunities. The absence of an effective audit program deprives management of an understanding of the issues within their Quality System. As a result, management is oblivious to the lacunae in the Quality System and the risk bring for the organization. Such a situation denies the management the opportunity to assess the impact a faulty Quality Management System audit has on product quality and the risk it poses to the customer. Susanne will draw participants’ attention and focus on the red-flags and explain to them the ways by which they can reduce compliance and quality risk.

This seminar will consist primarily of lectures, interactive discussions and practical exercises. Susanne will equip the participants with the tools and techniques they need for ensuring compliance of their Quality Systems audits. They will walk away with an understanding of the key concepts and their practices, along with the ways of implementing them and use them as reference for future use

 

Article on “A Tour of the FDA”

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.

So, what is a tour of the FDA like?

A tour of the FDA helps to get a broad understanding of the this regulatory body and get some idea of the various departments it has, as well as the functions of these departments. To get an understanding of what the FDA does, a reference to its mission statement could give some direction:

“(The) FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This is just the opening line of the FDA’s mission statement. Reference to its other statements, which have now included a reference to containing terrorism, will serve as a good guide to a tour of the FDA. In short, the FDA regulates nearly every item used and consumed by the American public.

The history of the FDA

The legal sanction for carrying out its mission is mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act). An amazing fact that a tour of the FDA reveals is that it is one of the oldest regulatory bodies in the world, with its earliest jurisdiction having covered regulation of drugs in the year 1848. The Department of Agriculture, to which President James Polk appointed noted chemist Charles Wetherill, can be considered the earliest endeavor to regulate medical products of daily use in the US.

How is the FDA organized?

A tour of the FDA is incomplete without a reference to the way it is organized. Its structure consists of this hierarchy:

  • Office of the Commissioner
  • Office of Foods and Veterinary Medicine
  • Office of Global Regulatory Operations and Policy
  • Office of Medical Products and Tobacco
  • Office of Operations

Under these broad heads, a tour of the FDA shows the way into which it is divided into several offices and organizations. Important among these include:

  • Office of Regulatory Affairs (ORA)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Devices and Radiological Health (CDRH)
  • National Center for Toxicological Research (NCTR)

Want to know more: Article on “A Tour of the FDA”