Interacting with an Auditor

Types of languages

Verbal No-Verbal = body Lenguaje

No-Verbal Language

This can be more expressive than a word.Types of expressions:

Visual Contact

Gestos

Body Postures

Actitude

Be ready to Answer

Know your area of responsibility as the palm of your hand.  Study the procedures to be audited and verify that they are in compliance.  Define the Action Plan if you are not in compliance.  For questions about the implementation of some assignments, rinse before starting the audit.  Ensure that key members of your area are trained and available during the audit.

Before of Audit

Be ready to Answer

• Be calm.

• Be sure you clearly understand the question.

• Answer only what you are asking. No more information than had been requested.

• If you do not have the answer on hand, ask for time to get the correct answer.

In the Audit

Be ready to Answer

• Always go straight and tell the truth.• • If you are unsure, do not respond and

find the right person to answer.

• If you are not the expert on the subject, direct the question to the expert.

In the Audit

What to do during the audit?

• Listen carefully the questionIf you can rephrase the question.If you need the auditor to repeat and explain the question for you to have it more clear.

Speak clearly and slowly.

Speak only in their area of expertise.If you are unsure, do not respond.

Say only what you know you can confirm by objective evidence.

What does to do….

• Be consistent with what is going to say. This can

be documented in the FDA notes.

Stop when you know who has given his answer.

Always tell the truth.

What does to do….

• Do not enter into conversation with the auditor.The auditor is not your friend.Do not guess or make up an answer.Do not lie.Do not give more information than you requested.Do not speculate, you can give your reply later.Do not wait for the auditor requested information.

Do not

• Nape of evidence with post-its, notes written in pencil or unsigned quality records.

Do not try to change any existing practice without consulting and getting approval from management.

Do not react negatively about comments or observations made by the auditor.The comments will be reviewed by the group audit manager with the auditor.