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QUALITY | SAFETY | AUDIT | RISK

IATF 16949:2016
The future of automotive
manufacturing is process
readiness

Quality and Safety Management Solution


Q-Pulse | WHITE PAPER
®

IATF 16949:2016 is the most important quality standard for the automotive industry. One of the
drivers behind this standard is the rapid growth of the supply base in emerging markets and the
need to improve reliability of processes and risk mitigation.

Written as an industry specific companion to ISO 9001:2015, IATF 16949 sets out the QMS
requirements for all organisations in the automotive supply chain. As a companion, organisations
must also comply with ISO 9001:2015. Both standards prescribe a process based approach to
quality management systems in order to provide high quality products and services.

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OPERATIONS

DO
CUSTOMER &
OTHER 4 9
6 CHECK CUSTOMER
PLAN

RELEVANT CONTEXT OF
PLANNING PERFORMANCE SATISFACTION
INTERSTED ORGANISATION
EVALUATION
PARTIES
ACT

PRODUCTS
REQUIREMENTS 10 &
IMPROVEMENT SERVICES

Why is IATF 16949 Compliance Important?


By adopting IATF 16949:2016, organisations do not just commit to QMS excellence, they commit to customer satisfaction
through the delivery of high quality products or services. The customer typically being another automotive organisation.

The standard was written as a result of extensive industry consultation. The IATF was formed to create a consensus
between manufacturers and their respective trade associations. IATF members, and key to the drafting of
IATF16949:2016, include BMW Group, FCA US LLC, Daimler AG, FCA Italy Spa, Ford Motor Company, General Motors
Company, PSA Group, Renault, Volkswagen AG and the vehicle manufacturers respective trade associations – AIAG (U.S.),
ANFIA (Italy), FIEV (France), SMMT (U.K.) and VDA QMC (Germany).

These industry leaders are committed to the importance of quality standards in the automotive supply chain because it
means the parts and products they receive are quality assured. Many readers will recognise these names as customers.
IATF 16949:2016 was drafted to standardise supplier quality processes and by complying with this standard you can be a
trusted supplier.

This whitepaper will cover:


• Key compliance themes of IATF 16949:2016
• Overview of compliance requirements falling under each theme
• Critical capabilities for automotive quality management software

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®

Understand requirements and your business and manufacturing


performance
Process is king in IATF 16949. Organisations are expected to understand and document all processes, including the
processes of relevant external parties such as suppliers. Mapping of processes at a granular level are the only way to fully
appreciate your business performance – opportunities for continual development – and the potential impact of product
quality or safety failings.

Process planning is a prerequisite for risk management or mitigation. Before you can exert control over risk you must
understand the sources of risk. The first substantive clause of IATF 16949 asks automotive organisations to understand
the factors and stakeholders that impact the QMS. Clause 4 ties the QMS to business strategy, challenging the outdated
view of Quality as the responsibility of a select few.

CLAUSE 4 Document conformity to all customer, statutory and regulatory


KEY COMPLIANCE requirements
REQUIREMENTS Do your part to ensure product traceability through the supply chain

Document processes for management of safety related products and


manufacturing processes

Have the ability to identify safety-related characteristics

IATF 16949:2016 then goes in to detail on processes that are key to automotive industry performance and the importance
of documenting performance.

CLAUSE 8 Document the design and development process of products and services
KEY COMPLIANCE Operational planning that specifically recognises customer requirements,
REQUIREMENTS logistics, and acceptance criteria

Document process and criteria to evaluate the performance of external


providers

Clear communication between customers and the supply chain to build


shared understanding of requirements

CLAUSE 9 Retain information on dates of process change


KEY COMPLIANCE Verify adherence to all plans and processes
REQUIREMENTS

CRITICAL CAPABILITIES FOR THE IATF16949 PROCESS APPROACH

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®

Exert control over the sources of risk within and out with your
organisation and how to evidence this
The previous section detailed the various processes that the organisation must consider. As meeting customer
satisfaction and product safety are fundamental to IATF 16949:2016, ensuring the reality lives up to these plans is a core
requirement of the standard. Risk management is the tool through which organisations can keep their processes on
track.

IATF 16949 adds to the ISO 9001:2015 requirement for risk-based thinking with automotive industry specific tools for risk
management – PPAP, APQP & FMEA. Organisations must be able to provide assurance on manufacturing feasibility and
accept responsibility for conformity at all points of the supply chain below them.

CLAUSE 6 Identify and evaluate all internal and external risks to manufacturing
KEY COMPLIANCE process and assets
REQUIREMENTS Consider automotive specific risks such as product recall, product audits,
field returns, repairs, complaints and scrappage

Establish preventative action process that takes note of the severity of the
potential risk

Create and follow contingency plans for continuity of supply

CLAUSE 8 Validate your ability to make product at the required rate


KEY COMPLIANCE Document pre-launch and production control plans that includes
REQUIREMENTS manufacturing process controls, methods for monitoring of control and
reaction plans, where appropriate.

Ensure personnel are trained well enough to achieve design requirements

CRITICAL CAPABILITIES FOR MANUFACTURING RISK MANAGEMENT

8
OPERATIONS
APQP DFMEA FMEA
WORKFLOW

DO
4
6
CHECK
PLAN

CONTEXT OF
PLANNING ORGANISATION CONTROL PPAP PROCESS FLOW
PLAN WORKFLOW DIAGRAM

ACT

CA/PA TRAINING SUPPLIER


AUDIT

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®

Continual Improvement with more than Best Intentions


As quality management becomes a shared goal across your company, one of the benefits envisaged by the IATF is a
culture of continual improvement. Everyone involved in the Manufacturing process, Operations or Quality from time
to time recognise things that could be done better. Clause 10 focuses on continual improvement. This clause requires
organisations to be thorough in their investigations of issues, be open to opportunities for change and drive through the
required change.

Key compliance requirements of IATF16949:2016, Clause 10:

CLAUSE 10 Establish documented process for problem solving, warranty management


KEY COMPLIANCE and continual improvement
REQUIREMENTS Good communication with customers, including getting their approval of
your problem solving approach

Appropriate use of FMEA for error proofing of devices, control plans and
retention of test results

Capture and analysis of customer complaints

Include manufacturing process improvement action plan within continual


development plan

CRITICAL CAPABILITIES FOR EFFECTIVE CHANGE CONTROL

Clause 10 requires that change be planned and carried out in a systematic manner. A capable quality management
software standardises and automates the change control process to make reviewing and assessing the likely effects of
change more efficient. The system integrates change control with quality management processes.

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Q-Pulse | WHITE PAPER
®

IATF 16949:2015 Compliance Using Q-Pulse


Q-Pulse is the proven quality, compliance safety and operational risk management software
solution for thousands of organisations across the world. Since 2016, Q-Pulse has also included
automotive industry specific functionality for process validation.

PROJECT CONTROL
With Q-Pulse PPAP you can set the elements required by your process, change it based on customer requirements, assign
ownership, record start dates and define the all-important deadline for each element. The status tab gives instant visibility
of progress and elements at risk, so remedial action can be taken to keep the process on track.

RISK AND FMEA


The methodical Failure Mode and Effect Analysis (FMEA) functionality within Q-Pulse PPAP makes it easier to identify
which aspects of the manufacturing process is most likely to go wrong. Time is saved by using the process flow diagram
as the basis, to which potential failures, effects, causes, prevention and detection information is added. Q-Pulse
PPAP automatically calculates a risk priority number, making the decision whether or not to take corrective action a
straightforward one.

PROCESS FLOW
Building the process flow diagram within Q-Pulse PPAP saves valuable time that could be put to better use. Simply input
the operations, process steps and use the library of process step symbols to generate the document.

CONTROL PLAN
Q-Pulse PPAP ensures that all characteristics and processes are properly tested for quality. All manufacturing machinery,
inspection equipment, sample sizes, sample frequency and reaction plans are methodically documented with time saving
measures. Colour coding ensures that no characteristics or processes are missed from the plan.

SUPPLY CHAIN PORTAL


Manufacturing requires the sharing of information between interdisciplinary teams internally and supply chain partners.
Ideagen’s supply chain portal supports efficient sharing of product data across teams and geographies with the use of a
web portal.

APQP WORKFLOW
Q-Pulse NPI is a customisable workflow app used by automotive manufacturers to establish and manage a gated process
for implementing new parts or assemblies. Create workflow elements as required by project, assign accountability, task
management and statusing.

CAPA MANAGEMENT
Q-Pulse CAPA module provides a centralised corporate reporting system for your organisation, bringing with it the ability
to solve problems quickly and thoroughly to minimise impact and lessen the chance of re-occurrence. The module uses
pre-defined or standard reports to provide a repeatable process to capture and manage information effectively.

AUDIT MANAGEMENT
By taking advantage of the Audit module, the complete auditing lifecycle is at your fingertips, from planning, scheduling,
preparing, reporting and tracking of actions through to closure. The Audit capability can be made available off-line to the
main system to facilitate remote sites, suppliers or audits where the network or web infrastructure is incapable of reliable
connectivity, with data being seamlessly consolidated at a time that suits you.

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®

DOCUMENT CONTROL
By utilising the Q-Pulse Document Control module, you are armed with an information portal for all types of documents
of value – and not just those subject to formal change control.The module addresses the complete document
management lifecycle, including all actions and notifications associated with change requests, drafting, publishing,
approvals, change history and distribution.

COMPETENCE MANAGEMENT
The Competence module provides a user-friendly way to demonstrate compliance and allows organisations to progress
from record holding through training planning to competency management, encouraging organisations to continually
seek opportunities to operate or conduct business more effectively.

CUSTOMER MANAGEMENT
Every customer comment, positive or negative, is valuable. The Customer Management capability within Q-Pulse provides
the facility to keep a record of all customers who have made a comment about a product or service. The information can
be viewed and analysed and the response time monitored; any complaints not being addressed can automatically be
escalated for action.

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Contact Ideagen to discuss how our software solutions can support
your certification to IATF 16949:2016.

info@ideagen.com

+44 (0) 1629 699100

www.ideagen.com

Ideagen Plc
Ergo House, Mere Way, Ruddington Fields Business Park, Ruddington, Nottinghamshire NG11 6JS

e : info@ideagen.com | w : ideagen.com

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