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                              October - December 2011


Christine Park

Is Your Executive Management Team as Involved with the Quality System as They Should Be?

by Christine Park
Christine Park & Associates

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 this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems:

#1: "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..."

#2: "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)."

These examples are obviously blatant and send a strong message. Now is the time to step back and re-evaluate the role your executive management team is playing in your own quality system.

21 CFR 820 defines management with executive responsibility as "those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system." What does this really mean and how can you as a Quality Professional help your executive management team meet these requirements in the course of every-day business practice?

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 responsibilities for management with executive responsibility can be distributed into four key areas of focus:

  • Core competencies
  • Internal audit program
  • Meaningful metrics
  • Risk management

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