Monday, July 30, 2012

Ready for an audit? Prepare for Success!

All companies may be audited at one point or another – no escaping the Tax Man if your number comes up! ISO-certified companies require periodic inspection by a registrar to maintain their certification status. If food, drug, cosmetic or life-saving devices are manufactured or repaired, then a visit from the country-specific government health agencies (e.g., FDA for USA) can be expected.

Are you and your company ready to be audited? Do you know what steps you should take to make the audit as smooth as possible?


Audit preparedness is everyone’s responsibility!

  • Create a culture of awareness Does your team understand what an audit is? Do they understand their role in the audit, and why your company is being audited?
  • Do what you say you do Do you understand your job responsibilities? Are job descriptions updated? Is your resume / CV up-to-date? Did you ensure your documentation is filled out completely, accurately and is free of good documentation practices (GDP) errors? Are organization charts up-to-date?
  • Quality is Job One Ford had it right in the 1980s with this marketing campaign! Quality is the responsibility of each and every employee. Do you know your company’s Quality Policy? Can you explain it in your own words? Can you identify defects or non-conformances in your job function? Do you understand the impact of defects or non-conformances on consumer safety and product quality? Is non-conforming product clearly identified and segregated from in-process or conforming product?
  • Training: “What I do, I understand." – Confucius Training is a key element for any employee to do his/her job properly. Auditors will be looking for verification of this in the form of your training records. Are your training records up-to-date and available for review? Have you been trained and certified to all procedures required on your job's training matrix? Are you performing any work that you are NOT trained/certified to?
  • First Impressions are Lasting Impressions Is your work area is neat and orderly? Do you have controlled or uncontrolled documents on your desk? Are you using the latest revision of your procedure(s)? Did you verify the revision? Are post-its or scraps of paper being used to document activities? Are your work areas clearly identified?
  • Practice, Practice, Practice!! Best way to get ready for an audit is to perform practice or mock audits. Running through a simulated audit can identify any deficiencies that need fixing, help ease those auditor interview jitters, and get everyone in an audit-readiness state of mind!

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