Building an IATF 16949 QMS That Works Beyond the Audit

Achieving and maintaining IATF 16949 certification requires organizations to establish processes, controls and documented information that meet the requirements of IATF 16949, applied together with ISO 9001:2015.

But certification should not be the only measure of whether the quality management system is working.

The real test is what happens between audits.

Does the QMS help the organization identify and manage risk? Do Control Plans reflect what is actually happening in production? Are lessons learned feeding back into FMEAs? Are Customer-Specific Requirements understood by the people responsible for implementing them?

A strong IATF 16949 quality management system should support the way the organization operates — not exist as a separate system maintained primarily for certification.

Start With the Process, Not the Paperwork

Documented information is an important part of any quality management system, but having a procedure does not automatically mean the process is effective.

The focus should therefore extend beyond whether the required documentation exists.

Organizations should also be asking whether processes are achieving their intended results, whether procedures have been effectively implemented and whether the controls within the system are supporting consistent performance.

This is where the process approach becomes particularly important.

Procedures support processes. They should not become the primary objective of the QMS.

When documentation begins to exist mainly as evidence for an audit, there is a risk that the organization develops a system that looks effective on paper but does not accurately represent how the business operates.

Integrate Customer-Specific Requirements Into the Business

IATF 16949 provides a common framework, but automotive organizations must also evaluate and incorporate the requirements of their individual customers.

Customer-Specific Requirements (CSRs) therefore need to be identified, understood and integrated into the relevant areas of the organization.

This responsibility should not sit with the quality department alone.

Depending on the requirement, people within engineering, production, logistics, material handling and other functions may all need to understand the CSRs that apply to their activities.

The objective is not simply to maintain a list of customer requirements. Those requirements need to make their way into the processes and procedures used by the people responsible for delivering them.

Use Internal Audits to Understand What Is Really Happening

Internal audits provide organizations with an opportunity to look critically at their own processes before weaknesses become larger problems.

That opportunity can easily be lost when auditing becomes a checklist exercise.

Effective internal auditing requires competent auditors who can evaluate processes rather than simply confirm that documentation exists. IATF 16949 sets specific internal auditor competency requirements that must be demonstrated and maintained.

That includes understanding applicable ISO 9001 and IATF 16949 requirements, the process approach and risk-based thinking. Depending on the area being audited, auditors may also need appropriate knowledge of tools and documentation such as FMEAs and Control Plans.

A useful internal audit should provide insight into how effectively the process is operating and where genuine risks or improvement opportunities exist.

A complete internal audit programme should also cover the three required audit types: quality management system audits, manufacturing process audits and product audits. 

Keep Core Tools Connected to the Process

Core Tools are most valuable when they remain connected to day-to-day operations.

FMEAs, Control Plans and other quality planning documents should not be treated as documents that are completed for a particular submission and then left unchanged.

Processes evolve. Risks change. Problems occur. Improvements are introduced.

The relevant quality documentation needs to reflect those changes.

An FMEA should continue to represent the risks associated with the product or process, while the Control Plan should remain aligned with the controls actually being applied.

If the documentation says one thing while the production process does another, the QMS is no longer accurately representing reality.

Make FMEA a Cross-Functional Activity

The effectiveness of an FMEA also depends on the people involved in developing and reviewing it.

One person is unlikely to have complete visibility of every potential risk associated with a product or manufacturing process.

A multidisciplinary approach brings together different knowledge and experience from across the organization. Engineering, quality, production and other relevant functions can each identify risks from a different perspective.

Where the organization has no design responsibility, this multidisciplinary work centres on the Process FMEA and its link to the Control Plan.

This helps make the FMEA a practical risk-management tool rather than simply a completed document.

There also needs to be a clear connection between the FMEA and the controls that follow from it.

Risks, special characteristics, Control Plans and the controls implemented within production should form part of a connected system.

Make Sure the Control Plan Reflects Reality

The shop floor provides one of the clearest tests of whether the documented quality system is working.

The controls taking place within production should align with what has been defined in the Control Plan and supporting documentation.

Problems arise when additional controls or error-proofing measures have been introduced in production but are not reflected in the relevant documentation, or when documented controls are no longer being applied as originally defined.

For example, if an additional error-proofing control is introduced following a customer complaint, the Control Plan should be reviewed and updated as appropriate to reflect the change.

Production teams can provide valuable input when Control Plans are reviewed because they work directly with the processes and controls every day.

This creates an opportunity to connect engineering, quality and production more closely while ensuring the documented system remains aligned with actual operating conditions.

Feed Problems Back Into the QMS

Problem solving should not end when the immediate issue has been contained and corrected.

Customer complaints, nonconformities and other process failures can provide important information about weaknesses within the wider quality system.

Where a problem identifies an ineffective control or previously unidentified risk, organizations should consider the impact on the relevant FMEA, Control Plan and associated processes.

This allows lessons learned to become part of the system.

Rather than repeatedly responding to individual problems, the organization can use those problems to strengthen its understanding of risk and improve the controls intended to prevent recurrence.

Connect Quality With Leadership and Business Performance

An effective QMS also requires more than the involvement of the quality department.

Leadership involvement is an important part of establishing a system that is integrated into the organization.

Processes need ownership. Performance needs to be monitored. Relevant KPIs need to be reviewed. Training needs to take place when required, and risk-based thinking needs to influence actual decisions rather than simply appearing in documented procedures.

Problem solving and corrective action also need to address genuine root causes, supported by appropriate data and followed through to effective action.

When these elements work together, the QMS becomes part of how the organization manages performance rather than an additional layer of activity created for certification.

From Conformance to an Effective Quality Management System

IATF 16949 certification remains important, but preparing for an audit should not be the point at which the quality management system receives the most attention.

A better way to identify whether the system is delivering value every day is to ask:

• Are processes understood and controlled?

• Are customer requirements integrated?

• Are risks actively managed?

• Do the FMEA, Control Plan and shop-floor reality agree with one another?

• Are audits identifying meaningful opportunities for improvement?

• When something goes wrong, does the organization learn from it and strengthen the system?

These are the areas that help move an IATF 16949 QMS beyond conformance and towards a system that supports consistent quality, defect prevention, reduced variation and waste, continual improvement and customer satisfaction.

Turning these everyday questions into consistent practice is where focused, experienced support can make a difference.

Strengthen Your IATF 16949 QMS with ENCONA

ENCONA supports automotive organizations in developing and strengthening their quality management systems through IATF 16949, Internal Auditor and Core Tools training, as well as auditing and consulting support.

Whether your organization is working toward IATF 16949 or looking to improve the effectiveness of an established QMS, contact ENCONA to discuss your training and support requirements.