gov 2015 slide 1 iso 9001 auditor training d'angelo advantage consulting llc rita d’angelo...

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ISO 9001Auditor Training

D'Angelo Advantage Consulting LLC

Rita D’AngeloAFDO San Diego, March, 2015D’Angelo Advantage LLC Consulting

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Description of the Course

This course will provide the learner an overview and a “hands on” approach to perform an audit, verify compliance and/ or non-conformances and provide a report to leadership within your organization.


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Learning Outcomes

The participant will: Understand the ISO 9001 Quality Management

System requirements , definitions, terms and ISO 9001 standard

Understand the process approach to auditing Apply principles learned to define the

objectives, scope and criteria of the audit Verify the conformity of the known standard

against the current process Prepare audit reports


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Definitions


Audit: The on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process or production stepNonconforming record (NCR): A permanent record—made in writing—for accounting and preserving the knowledge of a nonconforming condition for the purposes of documenting facts or eventsNonconformity: The nonfulfillment of a specified requirementPreventive action: Action taken to remove or improve a process to prevent potential future occurrences of a nonconformance. Quality audit: A systematic, independent examination and review to determine whether quality activities and related results comply with plans and whether these plans are implemented effectively and are suitable to achieve the objectivesRoot cause: A factor that caused a nonconformance and should be permanently eliminated through process improvement

ASQ 2015

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Agenda

What is ISO? ISO 9001 Standards 2015 DIS

Revision Establishing the audit Preparing the strategy The Process approach to auditing Exercise: Audit checklist

preparation Audit learning process Conducting an mock audit Exercise: Conduct YOUR audit


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Understanding ISO 9001


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What is ISO?

“ISO” in Greek “isos” , in English “isosceles” meaning “equal”

ISO Standards: A set of standards that apply to all users equally

Standard: Is a guidance document in a specific

discipline/ technical area developed through expert consensus


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ISO 9001: What is it?

ISO – International Organization for StandardizationGeneva, Switzerland

Based on ISO/IEC 17025 and ISO 9001 Worldwide Federation with 19, 500 standards

in 163 countries

1946

ISO's first standardIn 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference temperature for industrial length measurements developed by

A panel of experts, within a technical committee

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ISO 9001 Standard


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1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization (Quality Management

System)4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of

interested parties4.3 Determining the scope of QMS4.4 Quality management system and its processes

5 Leadership (Management Responsibility)5.1 Leadership and commitment 5.2 Quality policy5.3 Organizational roles, responsibilities and authorities

6 Planning for the QMS (Resource Management) 6.1 Actions to address risks and opportunities 6.2 Qquality objectives and planning to achieve them 6.3 Planning of changes

Structure of ISO 9001:2015

http://asq.org/standards-iso-9001-2015.html

1/3

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7 Support (Product Realization)7.1Resources 7.2Competence 7.3Awareness 7.4Communication 7.5Documented information

8 Operation (Measurement, Analysis and Improvement)

8.1Operational planning and control8.2Determination of requirements for products and

services 8.3Design and development of products and services 8.4Control of externally provided products and

services8.5Production and service provision8.6Release of products and services8.7Control of non conforming process outputs,

products and services



2/3

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9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.2Internal audit

9.3Management review

10 Improvement

10.1 General

10.2 Non-conformity and corrective action

10.3 Continual improvement



3/3


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ISO 9001 sets the criteria for a quality management system and is the only standard in the family that can be certified

Ensure customers get consistent, good quality products and services, which in turn brings many business benefits

Purpose for Accreditation


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Goals of Auditing

1. Identify organizational problems and risks

2. Identify best practices and share with other groups

3. Reduce variation

4. Identify opportunities

5. Improve organizational performance

6. Increase customer satisfaction


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Process of an Audit

Establish the Audit

Conduct the Audit

Review Documents

Prepare the Strategy

Audit Report


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Establish the Audit

Planning Phase

D'Angelo Advantage Consulting LLCD'Angelo Advantage Consulting LLC

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Process Approach to Auditing


http://www.slideshare.net/abrhamabebe/9101changes

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Review Documentation


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ISO 9001 Standard

Technical Standard

Prior Non-conformances

Safety citations

Facilities documents (procedures, policies, Quality manual) etc

Documentation Prior to Assessment


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Prepare the Strategy


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Plan for the Audit

Step 1: Develop audit strategy

1. Research prior audits2. Identify risks3. Review any external audit results4. Receive direction from leadership5. Consider leads from accreditation agencies6. Review strategy with organizational

leadership


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Auditing Forms


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Gather Forms1. Audit documentation form2. Develop an audit check list


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Planning for the Audit

Step 2: Form the Team

1. Choose team members skilled and educated in each area of discipline

2. Ensure auditor training is current


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Step 3: Schedule the Audit

1. Develop a schedule to ensure are sections of the standard are covered

2. Discuss the schedule with the team

3. Share the schedule with organizational leadership


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Audit Schedule


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Step 4 : Schedule the opening and closing meeting


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Objectives Opening Meeting

Introduce audit team members to the auditees and senior leadership Review the scope, objectives and provide a short summary of the methods and procedures to be used during the course of the audit Clarify the details of the audit plan Verify time and date of any interim meetings Verify time and date of closing meeting

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Objectives Closing Meeting

Present leadership with a copy of the preliminary audit report No new information is presented here

Discuss the positives aspects of the company, leadership, staff and best practices Present the report and discuss conclusions including non-conformances Discuss the follow-up, report closure process and time frame for completion


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Audit Report

1. Cover page2. Introduction3. Purpose and scope that was contained in either the

audit plan or notification letter4. Results and summary: the overall conclusions and

recommendations.5. Detailed results: a listing of all findings.6. Supplemental clarifying information (Asq 2015)


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Establish the Audit Roles


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Lead Auditor

1.Plan and schedule the audit2.Form the team3.Provide documentation and review with the team4.Assign standard segments to the team5.Plan an conduct opening meeting6.Assist the auditors7.Review conformances8.Discuss obstacles and challenges with leadership9.Lead closing meeting10.Provide audit report11.Manage audit closure


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AuditorReview the following:

1. Prior documentation and audit reports2. Non- conformances3. ISO 9001 Standard

Perform the Audit1. Interview staff 2. Ask objective questions3. Review documents4. Seek audit lead if necessary5. Complete audit form6. Review the non-conformance with management7. Submit and review documentation with the Lead8. Attend closing meeting9. Discuss non conformance and answer any questions


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Audit Preparation Exercise

1.Review the standard

2.From your audit strategy choose 4 clauses to audit your process

3.Generate 1 question from each clause


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Audit Learning Process


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Research Involvement: 1. Department and area of interest

1. How many employees?2. How many tests?3. Problem area?

2. Management, supervisors, leads3. Employees who may be interviewed

Understand Management and Staff


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ASSESS THE SYSTEM , NOT who did it.

ASK? What system weakness allowed this non-conformance to occur?

What to Assess?


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1. Converse with staff2. Ask open ended questions3. Observe activities 4. Review Records ( make copies of non-

conformances)5. Review Documents(procedures)(Note: This is a guide and these steps can be rearranged)

Steps to Assessment


Copy and Maintain Documented Evidence

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Keep open conversation-2 way questions open ended notes Review 5-6 documents

Internal Assessments: review 10-20 documents

Collaborate with team if unclear

During the Interview


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Use the following: How, What, Where, Why, When….. Where can we find Could we have a look at Can we review….. Show me….. What happens when….. How have you met ….. So, can you tell me of your last

management review….. What is your role in management review….. Walk me through….. You seem very busy. How do you deal

with….. Can you tell me more of how that occurs…..

How to Phrase Questions


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ISO 9001 Assessment: Assessors Look for Conformance NOT Non-Conformances

Internal and External Inspections: Inspectors Look for Problems and Deficiencies

Difference Between Assessment

& Inspection


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“Essential requirement” contain “shall” and are mandatory

Recommendations are“Good practice/best practice”

ISO 9001 Terminology


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Non-fulfillment of any requirement to a major degree:

QM/procedures/protocols- do not address requirement

Procedures not consistently followed

Non-conformance consistently occurring, including repeat of non-conformance in the majority of requirement

Non-conformance has potential to directly impact safety*

Non-Conformance


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DO NOT USE- PAST TENSE, or “Should” Avoid providing solutions to problems this prevents an opportunity to do a root cause analysis Never specify names of individuals responsible for the Non ConformanceAudit language There is no evidence… There is insufficient evidence Current practice does not reflect Current documentation Not all There is lack of evidence Not all _____ The procedure for _____ has not been fully implemented

Not every…Restate clauseThe requirement for____ has not been fully metAs applicableAttach – and for example……

Terminology


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Conduct the Audit

Training


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7.2 The Organization shall: Determine the necessary competence of persons

doing the work under it control that affects its quality performance Ensure that persons are competent on the basis

of appropriate education, training and or experience

Take actions to acquire the necessary competence and evaluate the effectiveness of actions taken

Retain appropriate documented information as evidenced of competence

7.2 Competence


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Auditor/ManagerAuditor: How do you provide and document continuing education for employees?

Manager: Our staff are in-serviced when assigned to new area. The employee completes an evaluation before they work alone

Auditor: Can I see documentation?Manager: Yes

Auditor: Reviews records, policies and procedure to determine compliance

Scenario 1- (7.2 Competence)


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Auditor-Reviews employee training records revealing inconsistent education. Policy/procedures stated: Evaluations required before employee can work independently

Steps: 1. Requirement # ( Hint: ISO 7.2 Competence)2. Category (major/minor) 3. State Requirement: 4. Comments (Phrase your citation):

Scenario # 1


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Requirement: 7.2Category: Major Non conformance Requirement States: Determine the necessary competence of persons doing the

work under its control that affects its quality performance Ensure that persons are competent on the basis of appropriate

education, training and or experience Take actions to acquire the necessary competence and

evaluate the effectiveness of actions taken Retain appropriate documented information as evidenced of

competenceComments: There is inconsistent documentation of records of education prior to performing task

Scenario #1:Non-Conformance


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Auditing Findings Form


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Exercise: Conduct Your Audit

1. Perform the role of auditor role with your neighbor

2. From your check list interview the auditee for objective evidence based on your audit process 3. Document any non-conformances noted

4. Present to the group: What you’ve learned

What you would have done better


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Lessons Learned

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QUESTIONS??

[email protected]


mailto:[email protected]

gov 2015 slide 1 iso 9001 auditor training d'angelo advantage consulting llc rita d’angelo...

Documents

understanding iso

iso international organization

quality audit

current process

strategythe process

quality system

process improvement

quality activities