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By: Shravan Dubey
Facing Audits/Inspections
Internal Audits / Self Inspections
Customer Audits
Kinds of Audits
Audits
Regulatory Audits
Other audits (ISO, EHS,
CQA, commercial
visits)
Intentions of Audits
To verify the systems /process as committed by the firm, in view of patient safety.
To collect the evidences (that the correct medicine with
assured quality is achieving to patient)
He may be our relative
or we own!!!
Reason for Audits
To verify the:
Assessing compliance status
Approving of new
facilities
Issuing new
permissions
Renewing of license
Periodic visits
Investigations purposeRecalls
Serious complaintsCounterfeits
Due diligence
Business or
technical capabiliti
esPeriodic reviews of complianc
es
Importance of Audits
New business opportunities Business continuity Market leadership advantages Easier and faster regulatory approval System compliances To improve quality management systems To improve the quality of product To meet the cGMP
Facing of AUDIT
Opening Meeting
Do’s Welcome of Auditors
Self introductions Share business Cards
Scope of audit should be discussed Limited general talk with mild smile Notify auditors up fronts
Opening Meeting
Do’s Effective presentation with soft colors Tea or Coffee should be ready Bouquet or flower should be on table
Map the facility describing various area Print out the copy of presentation Keep ready the Organizational chart
Remember!!!First Impression is the last
impression
Opening Meeting
Don'ts Absent during welcome Long talk Absence of subject matter Exceed smile Through business cards Take long time for discussion Whisper
Preparations for Audit
Back room should be strong Subject matter experts should be present All possible documents should be available Runner for fetching of document in time Person as “SCRIBE” to keep notes Extra stationary should be available (transparent folders,
stapler, stapler pins, office files, etc…. Washroom facility should be in executive conditions Lunch should with suitable food
Preparations for Audit
All Quality Documents should be reviewed Product related informations should be
available APQR from last three years (minimum) Process flow diagram Vendor details and documents RM details (using in manufacturing) Hazardous material handling informations Information about Product manufacturing
at site Facility housekeeping along with
surroundings Safety practices Safety slogans Emergency numbers, ambulance
availability Preventive maintenance documents
Paste control documents Recruitment policy Attendance system policy Outside training details Workmen training details Dressings of employees should be clean Personnel hygiene awareness
Back room
Review of documents quickly before of it goes in to hands of Auditor.
Give and take record Qualification records All department SOPs Site master file, VMP, Quality Manual Stability data Particular product validation (process and cleaning), BMR,
Specifications Site lay out Experts for subjects
Facility Tour
Facility housekeeping should be excellent Outlook should be perfect (Painting, Lightening and
scheduling) All shop floor personnel should be confident for their work Be clear and be transparent with respect to our work Knowledge of subject which is being done Flawless tour from Material entry to Material exit If found any deficiency : first convince the auditor if it is
actually not which auditor under stood. If it is deficiency then accept it and commit to resolve.
Documentation
Do’s Should be given within 5 minutes Should be in presentable condition. Serve the document on desk to desk Remove documents if it is review (with permission) Reply only those questions which are asked Be clear during Q&A with inspector / auditor Speak with confidence Answer with facts along with evidences Every thing which is said to auditors should be on record
Documentation
Don’ts No mixing of documents No additional reply or over answer Don’t use work “I think” Don’t argue during discussion (by third person) Use word “excuse me” if any addition Don’t afraid of silence Don’t leave alone the inspector / auditor Don’t laugh more than enough
During the Audit
Unacceptable points: Become defensive and start arguments Make blunt refusals on the requests Speculate or guess an answer Respond to questions outside your expertise Attempt to answer a hypothetical question Intentionally mislead of lie Start blaming others or departments for the mistakes Make any personal comment on the quality of the investigator Generate questions by offering un-requested information or asking questions
of the Investigator Recording investigator discussions in the audit room
Your behavior
Should be Polite Good listener Good Acceptor Positive attitude Technically sound Well experienced subject
matter Gentle Well dressed Good convincer Supportive
Should not be use “I” Think Suppose Believe Usually Sometimes By practices To be honest
Wrap up
Take a diary for notes (general observations) Thanks speech for auditing the facility Share the learning's Keep eye contacts Ask “is there any critical issue”. Arrange to provide documents (is asked by auditor during audit) Gifts hand over session if required Leave them up to their Cars Say “bye and take care”
Response
Say thanks after receiving of observation report Provide time line for the completion of compliance report Share the compliance report along with evidences Follow up for the receipt of the compliance report Follow up for the closing of observations
Thank You