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© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
How to conduct Stage 1 and Stage 2 Audits As per ISO 9001 – 2015 & ISO 19011
FREE Professional Development Seminar Series
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
At the end of the class, please fill the training feedback and referral forms!
Return the form at the reception!
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Outline
• About 3FOLD Education Centre• Brief on ISO 9001:2015 and ISO 19011• Overview - Audit Process• Planning for state 1 audit• Conducting stage 1 audit• Making stage 2 audit plan• Making working documents• Conducting stage 2 audit• NCR reporting, Corrective action and • Audit report• Q &A• Certificate collection
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
About 3FOLD• Established in 2008
• Branches in Abu Dhabi and Dubai.
• Approved by KHDA, PMI, ASQ, IMA, AACE and CQI IRCA.
• An ISO 9001:2015 Certified Training Organization.
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
1. Scope 2. Normative references
3. Terms and definitions 4. Context of organization
5. Leadership 6. Planning
7. Support 8. Operation
9. Performance evaluation 10. Improvement
I N T R O D U C T I O N
Brief on ISO 9001:2015 Standard
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Standard ISO 19011 :2011
ISO 19011 is an international standard that sets forth
guidelines for management systems auditing.
• A clear explanation of the principles of management systems auditing.
• Guidance on the management of audit programs.
• Guidance on the conduct of internal or external audits.
• Advice on the competence and evaluation of auditors.
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Decide
Surveillance
Stage 2
Stage 1
Preparedness
Adequacy
2. Readiness
Conformity Assessment
3. Certification
CA & Improvements
4. Effectiveness
Commitment & Sign-Off
1. Contractual Process
Certification Roadmap
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Planning of Audit – ISO 9001:2015
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
The Quality audit is define as “ a systematic & independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives”.
For certification it is termed as Stage 1 and Stage 2 Audits. Stage 1: Adequacy auditStage 2: Compliance audit
Remember:
“Say what you do and do what you say”
(1) Adequacy audit:- (System or Management audit)
determine the extend to which the documented
information adequately meet the requirements
of standard.
(2) Compliance audit:-
Which seeks to establish the extent to which the
documented system is implemented and
observed by the work force.
Audit – ISO 9001:2015 QMS
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
• Performed to determine the state of readiness
• Identify key areas and technical expertise and exclusions
• Conformity of the documented system with the audit standard and applicable legislation is assessed
• Deficiencies are reported for corrective action, prior to the Stage 2 Audit
Stage 1 Audit - Overview
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
Source: ISO/TC176/SC2
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
Source: ISO/TC176/SC2
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
Source: ISO/TC176/SC2
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
PROCESS A
PROCESS C
PROCESS B PROCESS D
Inputs to A
Inputs to B Outputs from A
Inputs to C Outputs from C
Outputs from B Inputs to D
Outputs from D
Outputs from other processes
Outputs from other processes
Source: ISO/TC176/SC2
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Measurem
ent, Analysis, and Im
provement
OI
IO
I O
I O
I O
I O
I O
I O
Resource Processes
Product Design
Process Design
Project Planning
Production
Management Processes
Measurem
ent, Analysis, and Im
provement
OI
IO
IO
I OI O
I OI O
I OI O
I OI O
I OI O
I OI O
Source: ISO/TC176/SC2
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Stage 1 Audit - Overview
PLAN: Establish the objectives and processes necessary to deliver results in accordance with customer, statutory and regulatory requirements and the organization's policies;
DO: Implement the processes;
CHEAK: Monitor and measure processes and product against policies, objectives and requirements for the product and report the results;
ACT: Take actions to continually improve process performance;”
Source: ISO/TC176/SC2/N544R3
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
• Verify context, issues, risk and scope
• Ensure adequacy of documented information
• Ensure scope, purpose, methods and team size is matching with application
• Assess readiness for stage 2 audit
• Focus on Stage 2 audit planning
• Ensure system is matured and improvement process
• Identify potential problems
Conducting Stage 1 Audit
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Documented information needed to be maintained by the organization
for the purposes of establishing a QMS. These include:
− The scope of the quality management system (clause 4.3).
−Documented information necessary to support the operation of processes(clause 4.4).
− The quality policy (clause 5.).
− The quality objectives (clause 6.2).
−This documented information is subject to the requirements of
(clause 7.5)
Conducting Stage 1 Audit
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Although ISO 9001:2015 does not specifically requires any of them,
examples of documents that can add value to a QMS may include: − Organization charts ,Process maps, process flow charts and/or
process descriptions, Procedures, Work and/or test instructions, Specifications, Documents containing internal communications, Production schedules, Approved supplier list, Test and inspection plans, Quality plan, Quality manual, Strategic plans − Forms
Conducting Stage 1 Audit
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Sample audit planTiming Auditor 1 Auditor 2
08.00 Opening Meeting
08.30 Managing Director – Context, Interested Parties, Leadership and Planning
09.30Determination of requirements
Legal RequirementsPurchasing/suppliers
10.00 Production Planning/Risk Raw Material Stores
10.40 Production - Tablets Production - Steriles
12.30 Lunch
13.30 Process Nonconformity Corrective Action Dispatch/ Shipping
14.00 Laboratory Quality - Audits & Review
14.45 Maintenance Control of Documented Information
15.15 Calibration Continual Improvement Measurement Analysis
16.15 Training and Competence Corrective Actions
17.00 Report Preparation
17.45 Reporting Meeting.
Close
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Preparing working document- Checklist
InquiriesEvidence and
Results
Production Area (8.1)
❖Interview Production Manager about production planning. Plan, results.
❖Observe equipment and settings
Employee interviews (5.2.2, 7.2)
❖Are you aware of the quality policy?
❖How does the policy relate to what you do?
❖What type of training have you had on QM?
• Question / Checkpoint
• Objective evidence
• Reference the requirements of audit
criteria
• Reference of documents / records
• Reference verifying documents (records)
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
• Conducting the Opening meeting
• Communication during the audit
• Collecting and verifying information
• Ensuring implementation as per documented information and standard requirements
• Preparing audit Conclusions
• Conducting the Closing meeting
Conducting Stage 2 Audit
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Objective evidence
Objective evidence exists showing that:
►Positive Findings
►Opportunities for Improvement
►Observations
►Non-Conformances
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Nonconformity Report (NCR)
NC Shall include:-
1. NC Statement (An element of the system which went wrong) What is
the Problem ? Describe clearly, concisely and factually.
2. The evidence (what , where or when actually was found) Where did it
occur or When it occur?
3. Why is it a non – compliance ? I.e., against which requirement ? The
requirement (what was supposed to be)
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
NCR and corrective action procedure – Audit Report
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Re-Cap
• Brief on ISO 9001:2015 and ISO 19011
• Overview - Audit Process
• Planning & Conducting Stage 1 audit
• Planning & Conducting Stage 2 audit
• Making working documents
• NCR reporting, Corrective action
• Audit report
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
ANY QUESTION ?
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
Upcoming Schedule
•Course Title •Date •Frequency •Timing
•ISO 9001:2015 QMS LA•ISO 45001:2018 OHSMS
•May 25 to June29, 2018•May 12 to June 09, 2018
•5 Fridays•5 Saturday
•PM•AM
© 2017 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD
END OF SEMINAR
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