Common nonconformities in iso9001:2015 3rd party audits · 2018. 4. 6. · 8 Mohsen N. Movahed, Katie Lehoullier / TUV USA –Canada / 18.02.01 Common NCs: • The organization is

COMMON NONCONFORMITIES IN

ISO9001:2015 3RD PARTY AUDITS

Mohsen N. Movahed, Katie Lehoullier / TUV USA – Canada / 18.02.012

WELCOME INTRODUCTIONS

Katie Lehoullier

Host

Training Coordinator

TUV USA Academy

Email: [email protected]

Twitter:@TUV_USA

LinkedIn: TUV USA, Inc.

Phone: 844-488-8872 or 603 870-8023

Mohsen Norouzi-Movahed

Presenter

Senior Auditor, Veto Power (ISO9001, ISO14001, OHSAS18001, IATF16949)

QE&R, QMS courses tutor

Business Development and Sales Director – Canada

Email: [email protected]

Twitter :@TUV_USA

LinkedIn: TUV USA, Inc.

Phone: +1 519-452- 6901 , +1 416 919 0111

mailto:[email protected]



(Ref.: 2016 reports)GLOBAL PRESENCE: TÜV NORD GROUP

3

International Companies Projects

TUV USA SERVICES & MAIN ACCREDITORS

Mohsen N. Movahed, Katie Lehoullier / TUV USA –

Canada / 18.02.01

4

Mohsen N. Movahed, Katie Lehoullier / TUV USA – Canada /

18.02.01

5

1. Introduction to TUV NORD

2. Purpose / Outlines

3. 4.1 Understanding the organization and its context

4. 4.2 Understanding the needs and expectation of interested parties

5. 4.3 Determining the scope of the quality management system

6. 6.1 Actions to address risks and opportunities

7. 6.3 Planning of changes

8. NCs count per subclause in 250+ audits

9. Frequency of NCs in 250+ audits

10. 7.1.5.1 General <Monitoring and measuring resources >

11. 7.1.6 Organizational Knowledge

12. 8.2.1 Customer communication

13. 8.2.3.1 <void> <Review of requirements related to products and services >

14. 8.4.1 general <Control of externally provided processes, products and services >

15. 8.5.1 Control of production and service provision

16. 9.2.2 <void> < Internal audit >

17. How much has ISO 9001:2008 actually changed?

18. ISO 9001:2015 New requirements

19. Changed existing requirements

20. Some recommendations/ notes:

AGENDA


18.02.01

6

1. To share common failures in implementation of new / changed requirements

2. To make value for quality field activist through prevention of similar NCs

3. To make a robust understanding of the requirements

4. Not a training session but a friendly exchange of experiment

PURPOSE/ OUTLINE


Common NCs:

• The organization does not have a mechanism to monitor its external and internal issues.

• The organization Is not reviewing its external and internal issues in a timely manner.

• The organization has not planned to review and monitor its external and internal issues.

Key notes:

Context : the circumstances that form the setting for an event, statement, or idea, and in terms of which it can be fully understood and assessed.

SWOT weaknesses: static in time, too far external environmental factors

Review ISO3100:2009- Risk management, principles and guidelines

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT


Common NCs:

• The organization is not reviewing information about its interested parties –relevant to its QMS- and their relevant requirements in a timely manner.

• The organization has not planned to review and monitor information about its interested parties –relevant to its QMS- and their relevant requirements.

• The organization –producer of low pressure gas flow meter- has not determined Measurement Canada as its interested party and therefore its requirements are not recognized by its QMS processes.

Key notes:

Any party that can make your product/service provision inconsistent is one of your organization interested party

Meaning of consistency : the same behavior in time

4.2 UNDERSTANDING THE NEEDS AND EXPECTATION OF INTERESTED PARTIES


Common NCs:

• The organization has excluded its product design activities whereas its strategic direction (came out of its external and internal issues review), its customer delegated authorities to change product specifications –except assembleabilityrequirements-, record of the last five product changed and validated design required its QMS to include product design.

Key notes:

Strives to make the scope very specific

Makes it more difficult to justify an exclusion for Design, if the organization actually performs a design function, for example.

4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM


Common NCs:

• The organization has developed a risk mitigation plan in which all actions are notes “out of company control”.

• In some cases, the organization actions against identified risks are not effective to mitigate risk. For instance, Risk : packaging staff are not competent to pack brittle models of glasses, Action: Train operators WHEREAS no operator is good in English language and training was held in English.

• The organization has not planned actions to address its identified opportunities.

Key notes:

Uncertainty : Predictability : Confidence : ….

Risk: A state of uncertainty where some possible outcomes have an undesired effect or significant loss.

Intelligent system

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES


Common NCs:

• In some cases, the organization has not reviewed consequences of changes on its QMS within planning of change implementation. For instance, consequences of material ordering method change on warehouse available space

Key notes:

None

6.3 PLANNING OF CHANGES


18.02.01

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NCs count per subclause in 250+ audits


159

24

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275

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4 Context ofthe

organization

5 Leadership 6 Planning 7 Support 8 Operation 9 Performanceevaluation

10Improvement

Frequency of NCs in 250+ audits# of NCs # of NCs per subclause


Common NCs:

• In some cases, measurement results are not reliable. E.g: measurement of extruded rubber compound by a Vernier. Result of 3 continuous measurements proves unreliable output.

• In some cases, the organization is not using suitable measurement device to control a specification. E.g: Vernier with resolution of 0.1 mm to measure a width dimension 24 ± 0.1 mm.

Key notes:

Data quality

Repeatability and reproducibility

7.1.5.1 GENERAL <MONITORING AND MEASURING RESOURCES >


Common NCs:

• The organization has not have a knowledge base to maintain its internal and external knowledge.

• The organization knowledge base in not accessible for related users. E.g: process engineer does not have access to the libraries on SharePoint to review current knowledge when planning a change

Key notes:

Knowledge management cycles : Zack, Bukowitz & William, McElroy, ….

7.1.6 ORGANIZATIONAL KNOWLEDGE


Common NCs:

• The organization has not developed and communicated specific requirements for contingency actions against the only paint blending machine failures with its customer.

Key notes:

None

8.2.1 CUSTOMER COMMUNICATION


Common NCs:

• The organization has been committed to its customer to supply cherry fruit fly but record of reviewing its ability before making commitment does not show that it has determined and reviewed its ability to meet CFIA (Canadian Food Inspection Agency) requirements

Key notes:

Database of statutory and regulatory requirements

8.2.3.1 <VOID> <REVIEW OF REQUIREMENTS RELATED TO PRODUCTS AND SERVICES >


Common NCs:

• The organization has not determined criteria for external providers evaluation based on their ability to meet requirements. Current criteria that classifies external providers is the duration they have cooperated with the organization.

Key notes:

None

8.4.1 GENERAL <CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES >


Common NCs:

• In some cases, the organization has not implemented actions to prevent human errors. During the audit of SMD process, it was found that gas release button and machine shut down button are both at the same size and red very close to each other. It has the risk of operator error on pushing the wrong button.

Key notes:

Refer to 8.3.3 and 8.3.4

8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION


Common NCs:

• The audit program of the organization has not considered importance of the processes and the results of previous audits to determine frequency of the audits. Previous audit (Jun) of HR shows no NC but 5 NCs for maintenance process. Previous 6 months internal performance results shows that OEE was less than 75% in Sep, Oct, Nov and slightly over it in Dec. HR process KPIs were all at a good behavior in the previous 6 months. Audit program shows that next audit of maintenance process is not planned for Jan but HR process is planned to be audited that month.

Key notes:

Risk based audit program

Performance based audit program

9.2.2 <VOID> < INTERNAL AUDIT >

HOW MUCH HAS ISO 9001:2008 ACTUALLY CHANGED?

14%

7%

79%

ISO 9001:2015 vs. ISO 9001:2008

Annex SL New New Rephrased Existing

Mohsen N. Movahed, Katie Lehoullier / TUV USA – Canada / 18.02.01 21


4.1 “Understanding the Organization and its Context”

4.2 “Understanding the Needs and Expectations of Interested Parties”

4.4 “Quality Management System and its Processes”

5.1 “Leadership and Commitment”

6.1 “Actions to address Risks and Opportunities”

6.3 “Planning of Changes”

7.1.6 “Organizational Knowledge”

ISO 9001:2015 NEW REQUIREMENTS


1. Scope of the quality management system

2. Control of Documents

3. Management Commitment

4. Customer Focus

5. Management Review

6. Human Resources

7. Customer Property

8. Corrective Action

9. Preventive Action

CHANGED EXISTING REQUIREMENTS


1. Think risk-based in each and every activity in your QMS

2. Use supportive standard guides such as ISO3100:2009

3. ISO9001:2015 helps you more than before to align QMS with your business

4. Don’t go very deep and don’t be too superficial with requirements

5. Collaborate and share your best practices about ISO9001:2015 with TUV NORD

SOME RECOMMENDATIONS/ NOTES:


Training Schedule

USA

ISO 9001:2015 Internal Auditor Training

March 13-14 – Chicago, IL Area

May 17-18 – Salem, NH

Food Safety Trainings

Implementing SQF Systems Ed. 8

February 26-27 – Orlando, FL

March 29-30 – Chicago, IL (Area)

PCQI Human Food

March 26-28 - Chicago, IL (Area)

April 2-4 – Boston, MA (Area)

May 22-24 – Orlando, FL

Training Schedule

Canada

ISO 9001:2015 Transition Training

March 16 – Mississauga, ON

IATF 16949 Transition Training

March 8-9 – Mississauga, ON

May 24-25 - Mississauga, ON

Food Safety Trainings

PCQI Human Food

April 19-20 – Mississauga, ON

TUV USA ACADEMY


Thank you for attending

Technical or Quotation questions please contact [email protected]

Questions regarding Training Courses contact [email protected]

