How to conduct Stage 1 and Stage 2 Audits

Transcription

1 How to conduct Stage 1 and Stage 2 Audits As per ISO & ISO FREE Professional Development Seminar Series

2 At the end of the class, please fill the training feedback and referral forms! Return the form at the reception!

3 Outline About 3FOLD Education Centre Brief on ISO 9001:2015 and ISO 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

4 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.

5 Brief on ISO 9001:2015 Standard I N T R O D U C T I O N 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

6 Standard ISO :2011 ISO 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.

7 Certification Roadmap Decide 1. Contractual Process Commitment & Sign-Off 3. Certification Stage 2 Conformity Assessment Stage 1 Surveillance 2. Readiness Preparedness Adequacy 4. Effectiveness CA & Improvements

8 Planning of Audit ISO 9001:2015

9 Audit ISO 9001:2015 QMS 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 audit Stage 2: Compliance audit (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. Remember: Say what you do and do what you say

10 Stage 1 Audit - Overview 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

11 Stage 1 Audit - Overview Source: ISO/TC176/SC2

12 Stage 1 Audit - Overview Source: ISO/TC176/SC2

13 Stage 1 Audit - Overview Source: ISO/TC176/SC2

14 Stage 1 Audit - Overview Outputs from other processes Outputs from other processes Inputs to A PROCESS A Outputs Inputs to B PROCESS B Outputs from B Inputs to D PROCESS D Outputs from D from A Outputs Inputs to C from C PROCESS C Source: ISO/TC176/SC2

15 Measurement, Analysis, and Improvement I O Stage 1 Audit - Overview Management Processes I O Process Design I Product Design I O Production O I O Project Planning I O I O I O Resource Processes Source: ISO/TC176/SC2

16 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

17 Conducting Stage 1 Audit 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

18 Conducting Stage 1 Audit 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)

19 Conducting Stage 1 Audit 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

20 Sample audit plan Timing Auditor 1 Auditor Opening Meeting Managing Director Context, Interested Parties, Leadership and Planning Determination of requirements Legal Requirements Purchasing/suppliers Production Planning/Risk Raw Material Stores Production - Tablets Production - Steriles Lunch Process Nonconformity Corrective Action Dispatch/ Shipping Laboratory Quality - Audits & Review Maintenance Control of Documented Information Calibration Continual Improvement Measurement Analysis Training and Competence Corrective Actions Report Preparation Reporting Meeting. Close

21 Preparing working document- Checklist Question / Checkpoint Objective evidence Reference the requirements of audit criteria Reference of documents / records Reference verifying documents (records) Inquiries 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? Evidence and Results

22 Conducting Stage 2 Audit 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

23 Objective evidence Objective evidence exists showing that: Positive Findings Opportunities for Improvement Observations Non-Conformances

24 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)

25 NCR and corrective action procedure Audit Report

26 Re-Cap Brief on ISO 9001:2015 and ISO Overview - Audit Process Planning & Conducting Stage 1 audit Planning & Conducting Stage 2 audit Making working documents NCR reporting, Corrective action Audit report

27 ANY QUESTION?

28 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, Fridays 5 Saturday PM AM

29 END OF SEMINAR Please Fill the FEEDBACK & REFERRAL FORM and RETURN IT to the RECEPTION.