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AUDITS

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by

agnes goor

on 24 January 2014

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Transcript of AUDITS

BEFORE

Audits to comply ISO requirements
Many different questionnaires, checklist,reports - all manual input
AFTER
Standardized Questionnaire
Maturity Assessments, include
- ISO requirements
- Customer expectations
- Company requirements
- where we wonna be....
AUDITS
NEW WAYS to
INTERNAL AUDITS

AUDIT or ASSESSMENT ??
BEFORE

Quality team as Auditors
5 certified auditor
AFTER
Cross-functional audit team
31 certified internal auditor


AUDIT TEAM
MATURITY CHECKLIST
8D APPROACH
REPORTS
All audits
visible at
same place
31 certified auditor
share ideas
external eyes
learning by doing
Audits as tool
for Continuous Improvement

Step1: Define expectation
Step2: Make assessment
Step3: Year over Year improvement
plan to reach world-class
BEFORE

No visibility on audits, actions

AFTER
Access to Audit database o Intranet by all
Reports

BEFORE

Audit report manually
Audit Performance not measured

AFTER
No audit report needed - all online
Reports by system

Database for all Audits
Quality
EHS
IT
customer
in standardized way
BEFORE

Hundreds of corrective action; follow up difficulties
AFTER
All actions registered into database dedicated by superior to action owner
Actions with due date followed by System - warning
Closed actions validated
IT TOOL
1. New Internal Audit Management Procedure for QMS, EHS and IM

QMS Document: PP-PP0001-01 "INTERNAL AUDITS PROCEDURE"

2. Internal Audit management database

Login to: http://hu712db05/




INTERNAL AUDIT PROCESS FLOW
Step 1:
Create a yearly audit plan by QMS Manager once in a year
Step 2:
Management review of the plan
Step 3:
Type the planned audits into the Audit Management Software
Step 4:
Approval of the yearly Audit Program by Quality Director and CEO
Step 5:
Auditor get automatic mail about audit request
Yearly Audit
Program Preparation
Execute Audit
Execute Corrective actions for non-conformities
Create new audit
Audit prepare (date and participants)
Execute Audit
Type answers, rating and auditor comments
Containment action with evidence
Root cause analysis and related preventive action with deadline
Audit approval Approved audit, ready to start
Step 1:
Inform audited area
Step 2:
Execute audit
Step 3:
Type into Audit Management software answers for given question and scoring the answers
Step 4:
System generate automatically non-conformity request according to rating
Step 5:
System generate audit report
Audit report send via mail for approval to the Area leader
Area leader dedicate action responsible
System send mail to responsible for execute actions
Step 1:
Implement Containment Action
Document by typing into the system the actions and upload evidence
NOTE: Deadline for containment action is 10 day
Step 2:
Root cause analysis
Document by typing into the system
Step 3:
Preventive action
Document by typing into the system the actions and upload evidences
NOTE:
Deadline for root cause analysis given by action responsible
In case deadline not kept, automatic mail warning
Step 4:
Action Validation by Quality
Planned audit for approval
Scored question list for approval and dedicating action responsible
Validation of uploaded evidence for preventive action
BEFORE

Problem description
Root cause
Corrective action
Effectiveness and validation missing

AFTER
D1: Problemdescription
D2: Containment action
D3: Root cause analysis
D4: Preventive Corrective action (PCA)
D5: Validation

Workflow and rigour
on systematic problemsolving

Only validated actions
can be closed
Who? Internal Auditor Team
Approved by: Area Leaders
Who? QMS Manager
Approved by: Quality Director, CEO,
Full transcript