Core Tools and IATF 16949:2016 Overview

Several sections of IATF 16949:2016 now specifically reference the Core Tools, including:

Section 4.4.1.2: Product safety

Section 8.3.4.1: Monitoring

Section 8.3.4.3: Prototype program

Section 8.5.1.1: Control plan

Section 8.5.1.4: Verification after shutdown

Section 8.5.6.1: Control of changes – supplemental

Section 8.6.1: Release of products and services — supplemental

Section 8.7.1.4: Control of reworked product

Section 9.1.1.2: Identification of statistical tools

Section 9.2.2.3: Manufacturing process audit

Section 10.2.4: Error-proofing

Section 10.3.1: Continual improvement – supplemental

Here are some excerpts...

Section 4.4.1.2: Product safety

This section includes identification of statutory requirements; identifying and controlling product-safety-related characteristics both during design and at point of manufacture; defining responsibilities, escalation processes, reaction plans, and the necessary flow of information including top management and customers; receiving special approvals for FMEAs and Control plans; product traceability measures; and cascading of requirements throughout the supply chain.

Section 8.3.4.1: Monitoring

This could include, for example, the periodic update of customer APQP schedule milestones, gate reviews, and open issues lists related to development activities.

Section 8.5.1.1: Control Plan

• This section strengthened the control plan requirements and aligned IATF OEM customer-specific requirements into the IATF 16949 standard. It also elevated a NOTE regarding customer approval to a requirement, and strengthened the control plan review and update criteria and linked to the PFMEA updates.
• Control plans are needed for the relevant manufacturing site and all product supplied, and not just for the final product or final assembly line, as an example.
• Although family control plans are acceptable for bulk material and similar parts using a common manufacturing process, care should be given to identify the degree of difference that is acceptable to apply this common control.

Section 8.5.1.4: Verification after shutdown

• The necessary actions after the shutdown period should be anticipated in the PFMEA, control plans, and maintenance instructions, as appropriate.
• A multidisciplinary approach should be used to identify any additional actions needed to address unexpected shutdown events.

Section 8.5.6.1: Control of changes – supplemental

FMEAs should be reviewed for any manufacturing or product changes, prior to implementation. Production trial run activities should be planned based on the risk and complexity of the changes.

Section 8.3.4.3: Prototype program

Regardless of whether the work is performed by the organization or by an outsourced process, the prototype program and control plan are part of the scope of the QMS.

Section 8.6.1: Release of products and services — supplemental

• These updates strengthen the standard to ensure process controls align with the control plan.
• To achieve coherence between the control plan and the planned arrangements to verify product and service conformity, the organization should conduct a regular control plan audit that compares the current approval status of the product and process with the actual controls applied in the manufacturing process.

Section 8.7.1.4: Control of reworked product

The risk analysis and customer approval requirements are interrelated; FMEAs should identify and address risks related to each possible rework of the characteristics stated in the control plan.

Section 9.1.1.2: Identification of statistical tools

• Requirements for the identification of statistical tools feature clarifications regarding the documented deployment of the use of statistical tools from DFMEA, PFMEA, and the APQP (or equivalent) process.
• The tool chosen in the APQP (or equivalent) process must be included in design/process risk analysis and the control plan.

Section 9.1.1.2: Identification of statistical tools

• Requirements for the identification of statistical tools feature clarifications regarding the documented deployment of the use of statistical tools from DFMEA, PFMEA, and the APQP (or equivalent) process.
• The tool chosen in the APQP (or equivalent) process must be included in design/process risk analysis and the control plan.

Section 9.2.2.3: Manufacturing process audit

The audit must also evaluate the effective implementation of the process risk analysis, control plan, and associated documents.

Section 10.2.4: Error-proofing

• The organization needs a process that both identifies the need or opportunity for an error-proofing device/method, and designs and implements the device/method.
• The FMEA would document whether the method impacts occurrence (a prevention control) or impacts detection (a detection control).
• The control plan needs to include the test frequency of the error-proofing devices, and records must be maintained for the performance of these tests.

Section 10.3.1: Continual improvement – supplemental

Changes in this section clarify the minimum process requirements for continual improvement: identification of methods, information and data; an improvement action plan that reduces variation and waste; and risk analysis (such as FMEA).

The AIAG Core Tools Software Project team is working hard to help the international automotive global supply chain meet these requirements with an intuitive, easy to use, and inexpensive SaaS offering.

Want to learn more?  Attend the AIAG Quality Summit Conference, Sept 18 - 19, 2018 in Novi, MI.