Total Productive Maintenance - Major Non Conformance Findings

Posted in IATF 16949

As of October 2017, the top major findings were with Total Productive Maintance in the IATF 16949 certification audits.


IAOB released the top 10 major and minor IATF 16949 findings as of August 2017. Total Productive Maintenance ranked number two as a major finding, and number one as a minor finding.

This top billing prompts a review of the TPM requirements, examples of possible documented evidence, and differences that cause a major or minor TPM finding.

IATF 16949:2016 requirements for 8.5.1.5 (TPM) were expanded beyond those found in ISO/TS 16949 and can be split into planning and action. Comments highlighted in bold are only suggestions of items an organization could include to meet requirements.

Planning (requirements paraphrased):


a) Identification of process equipment – (possibly list of equipment in preventive maintenance program)

b) Availability of spare parts for equipment listed in (a) above – (in-house parts or parts identified at the distributor or manufacturer of the equipment)

c) Provision for resources for machines, equipment, and facility maintenance – (probably in-house and manufacture/service organizations' employee training records and contractor information)

d) Packaging and preservation of all equipment, tooling and gauging

e) Applicable customer -specific requirements.

j) Overhauls of equipment as scheduled events – (probably inside of preventive
maintenance schedule or separate listing)

Operation of TPM program (requirements paraphrased:

f) Documented maintenance objectives: examples from standard - OEE, MTBF, MTTR and preventive maintenance objectives - These are inputs to management review. Notice the "and" in the standard. This indicates two metrics at a minimum - TPM and preventive maintenance attainment.

g) Regular review of the maintenance plan and documented action, plan when objectives are not achieved.

h) Preventive maintenance methods - (must have objectives and goals. See f)

i) Predictive maintenance methods as applicable.

Potential NCs:


Major Non-conformances

1. Having a plan, but no activity, no metrics reviewed in management review

2. Implemented TPM system but all metrics are below goal and no action is being taken to correct


Minor Non-conformances

1. Overhauls not a scheduled event

2. Presenting a PM plan stating it covers all TPM events

3. No TPM metrics - just PM attainment


No extension for IATF 16949 - Important Deadline

Posted in IATF 16949

If you have not started the transition from ISO/TS 16949 to IATF 16949, it is time to prepare.


Currently, there are no plans by IAOB or ANAB (oversight bodies) to approve or grant waivers for organizations that do not transition by the planned deadlines.

  • September 15, 2018 - Only IATF16949:2016 certificate is valid
  • September 15, 2018 - Only ISO 9001:2015 and ISO 14001:2015 certificates are valid
  • September 15, 2018 - Only AS9100D or AS9120B certificates are valid
  • March 1, 2019 - Only ISO 13485:2016 certificate is valid
Organizations may recertify to the revised standard(s) at their recertification audit. If that is not possible, upgrade at surveillance, otherwise a special audit will be necessary.

IATF 16949 Common Findings - by the IAOB

Posted in IATF 16949

October 2017

IATF 16949:2016's top 10 major and minor nonconformance's have been released by IAOB as auditing of the revised standard is underway by third-party auditors. What's interesting - 3 of the 10 NCs have been written in both categories.

Shared Common Findings


  • 8.5.1.5 Total productive maintenance
  • 6.1.2.3 Contingency plans
  • 8.5.1 (ISO) Control of production and service provision
These examples might be helpful as organizations complete implementation of IATF 16949:2016.  Also, to view the current top 10 list of major and minor findings as released by IAOB.

Risk Analysis - Section 6.1.2.1 (new IATF 16949 standard)

Posted in IATF 16949

Here is some useful information about Risk Analysis in the new IATF 16949 standard.  Click Play to listen to Brandon Kerkstra explain.


  bullet green arrow 25Additional requirements for risk analysis now include:

bullet green arrow 25
At a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

bullet green arrow 25Retaining documented information (Records) as evidence of the results of risk analysis
   
   

Comparing the Context of the Organization in IATF 16949

Posted in IATF 16949

Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard



IATF 16949



ISO/TS 16949:2009

ISO 9001:2015

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for  consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

NOTE 3    Understanding the internal context can be facilitated by considering issues related to values,   culture, knowledge and performance of the organization.

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

2.a) the interested parties that are relevant to the quality management system;

2.b) the  requirements  of  these  interested parties  that are relevant to the quality
management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.


No equivalent clause

Generally organizations address this by developing a vision statement and a mission statement; these are developed into a long term strategic direction and a strategic plan. These further lead to shorter 3 to 5 year business development plans, which are supported by annual goals and objectives. For small to medium size organizations, these may be unstated and undocumented and be in the mind of the owner or may not exist at all.

The issues can relate to:

Legal (FDA, FAA, DOT, EPA, OHSA)
Market & competition Technology development Cultural & social directions Economic development International Trade
For automotive specifically legal issues could relate to

1. Passenger restraints
2. Engine air emissions
3. Braking systems
4. Exterior light illumination and others depending on the types of products and position in the supply chain

Organization’s interested parties include:
Owner(s) – individuals, investment
companies, corporate ownership, stockholders
Employees Regulators Customers Competitors
Trade Associations
State and local business community Owners
Suppliers
Neighbors

For automotive specifically, interested parties could include AIAG, SAE, DOT and EPA,  ISO/TS certification body

For Tier 2 and below, interested parties include the OEMs that their customers supply to.  



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Context of the Organization in IATF 16949 - Determining the Scope

Posted in IATF 16949

dETERMINING THE sCOPE: Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard



IATF 16949



ISO/TS 16949:2009

ISO 9001:2015

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:

3.a) the external and internal issues referred to in 4.1;

3.b) the requirements of relevant interested parties referred to in 4.2;

3.c) the    products    and    services    of    the organization

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is notapplicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

4.3.1 Determining the scope of the quality management system — supplemental

Supporting functions, whe
ther on-site





4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes

2.2.a) the scope of the quality management system, including details of and justification for any exclusions  (see 1.2),



Scope requirements are more explicit

Required Content

Types of products & services Application of all requirements from ISO 9001 that are applicable – if they have

activities/processes they are to be included Boundaries of the QMS

Justification for any exclusions

Scope determined by considering external & internal issues, requirements of interested parties & products & services





Automotive Specific:
Scope must include supporting functions, (remote and on-site).

Only permitted exclusion is product design and development and this


Request a quote for a review or an ISO standards audit

Click here for a quote from ASR a 
accredited IATF Registrar or call directly toll-free at 888-891-9002 or 616-942-6273.

Planning - 6.1 in IATF 16949

Posted in IATF 16949

Planning 6.0: Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard



IATF 16949



ISO/TS 16949:2009

ISO 9001:2015


6.1    Actions    to    address    risks    and opportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.
6.1.2    The organization shall plan:

a) actions    to    address    these    risks    and opportunities;

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

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.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’  needs




5.4.2 Quality management system planning

Top management shall ensure that

4.2.a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1,  as well as the quality objectives, and

4.2.b) the integrity of the quality management system is maintained when changes to the quality management  system are planned and implemented.



There is not a comparable clause in 2008 version; only the very general that planning of the QMS should meet the process approach requirements and quality objectives

This revision expects that the QMS addresses identified risks arising from the consideration of the context of the organization and the requirements of interested parties

The context of the organization might lead to risks such as:

Product risks – FDA, DOT, EPA (examples gas mileage requirements on vehicles; product shipping risks-hazardous materials; vehicle lighting requirements; food and drug risks)

The requirements of interested parties may lead to risks identified during contract review such as short delivery times or difficult product requirements or suppliers ability to provide raw materials or components


Most of our clients will identify risks during contract review and take actions such as negotiating delivery dates or taking exception to product requirements or evaluating risks during design activities (especially design reviews, verification and validation) or identifying risks when selecting and evaluating suppliers



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accredited IATF Registrar or call directly toll-free at 888-891-9002 or 616-942-6273.

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Automotive

  • IATF 16949
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