How To Face Audits

Agenda
• Introduction
• Pre Audit preparation
• During audit preparations
• Post- audit preparations
• Do’s and Don'ts
 Introduction
• What sort of Audit we Face:-
• Regulatory Audit
• ISO - 13485 (Turkey, Ukraine, CE etc)
• Internal Audits
• Safety Audits etc
 Regulatory Audits
• Why Audits
• Regulatory Audits
• For assessing compliance status
• For approving new facilities
• For issuing mfg permissions
• For renewing licenses
• For investigations (Recalls, serious complaints
etc)
 Internal Audits
• Improvement audits
• Compliance status
• System audits
• Pre- regulatory audits
• QA audits
 Introduction
• Audits helps you
• Identify your strengths and problem areas
• Get Solutions and Recognitions
 Do your home work - systematically
• Read your SOP thoroughly
• You should be able to know each and every part
of the SOP
• One should be confident, competent,
knowledgeable, credible with good
communication skills
• Must know all the process of the functions
• Auditor is new to our process, keep your
presentation ready and explain, if required.
 Check List
• Make Sure following documents are updated
• Responsibility and Authority (Job Description)
• Competency Matrix
• Training Need Assessment Form
• Training Calendar
• Training/ Evaluation Record
• Manpower List
• Specimen Signature
• Requisition for Recruitment of Manpower (MPR)
• Organization Chart
• Competency Criteria
• Quality Objectives
• Medical Examination records and their MOU’s
Note:- Auditor may ask records from i.e. Production, QA, QC,
Stores, SCM, D & D and R & D.
 During Audit
• Arrive before time on the day of audit
• Be balanced during the audit
• Be confident while answering
• Do not challenge, politely disagree if you are
very sure
• You should know when to retract
 Post Audit
• While waiting for the Audit report, update the
same to the seniors
• Start working on Corrective Action and
Preventive Action (CAPA) if you are being
informed on the Non Conformity (NC’/s)
 Do’s
• When you are not sure or you don't
remember Use “If I remember right....”
• Auditor does not expect you to answer
everything, so do not spoil the show
• If there are abnormal things happening and
you don't want to commit use “Normally it
happens this way...”
 Don'ts
• Do not use phrase like “ Not us, another dept
has done it....” it means you are not in sync
with other dept.
• Do not use phrase like “To be honest with you
or to tell you the truth”, it means previously
you were not so honest and true.
• Do not break the trust built so far.
Be wary of the “Long Silence Techniques”

• Auditor asks you a question

• You reply
• Auditor listens and maintains long silence
(purposely)
• You become anxious to break the silence
• You add more to answers (mostly unwanted!)
• Auditor got enough to grill you
• Don't be over anxious to break the silence,
answer and show to the point, not a word more
 The Language Muddle
• Never speak in the language which auditor
doesn't understand
• Seek permission and translate the things to
him
• Watch the body language- be polite, patient,
attentive and respectful
• Never speak anything on official.
• There is nothing unofficial for an auditor when
he is at your site, whatever he sees and hear is
official.
• You Learn from Experience
• You learn better from bad experience
• Face more and more audits

Thank You and Good Luck!!!