Blog: Using DataLyzer Software: An Auditors’ Perspective

Introduction

In the automotive industry, adherence to IATF 16949 is more than a certification. It’s a commitment to quality, risk reduction, and continuous improvement across the supply chain. With digitization reshaping the way companies manage quality, software solutions are becoming integral to meeting IATF requirements. From an auditor’s viewpoint, the software used to manage quality data must do more than store information but instead it must enable structure, traceability, and accountability.

This blog offers insights from the auditor’s perspective, explores key compliance requirements of IATF 16949, and explains how the DataLyzer software modules are designed and configured to support those needs.

What Do IATF Auditors Look For in Software Systems?

Auditors evaluating IATF 16949 compliance are not just reviewing your processes but they’re assessing how effectively your systems support those processes. The software used in managing FMEA, MSA, Control Plans and SPC becomes part of that review. Auditors commonly focus on the following software-related elements:

a) Compliance with Standard Methodologies

• FMEA must align with the AIAG-VDA format and or any specially requested format from Customer Specific Requirements (CSRs).
• MSA must include relevant studies such as Gage Repeatability, Reproducibility, Bias, Linearity etc.
• SPC must demonstrate correct application of statistical rules, control limits, and variation tracking.
• Proper linkages between FMEA, Process Flows, Control Plans and other documents.

If the software or the system deviates from recognized methodologies, auditors may issue findings.

b) Traceability and Version Control

Auditors will look for evidence that changes to records (FMEA ratings, gage studies, control limits, etc.) are tracked over time. That means:

• Version history is maintained.
• Each change is traceable to a user, timestamped.
• Change reasons are documented.

 This is particularly important as an evidence of a proper document information control.

c) Linkage Between Quality Tools

Clause 8.5.1.1 of IATF 16949 requires linkages between the Process Flow diagram, PFMEA, and Control Plan. Auditors expect to see this flow clearly. Any software used should support and enforce these linkages.

d) User Access Controls and Security

IATF 16949 requires that records be protected against unintended changes. The software or system must have: 

• Role-based access control.
• Secure login/ Authentication.
• Audit trails of important user actions.
• Optional electronic approvals.

e) Data Retention and Backup

Under Clause 7.5.3.2.1, documented information must be retained and retrievable as long as required by internal procedures or customer-specific requirements. Auditors may ask:

• How long are records stored?
• Are backups made regularly?
• Are old versions recoverable?

Software Capabilities That Support IATF 16949 Compliance

At DataLyzer, the tools are developed with IATF compliance at the core. Below is described how each of the software modules align with IATF clauses and auditors expectations.

a) FMEA and Control Plan Module

IATF Clause 9.1.1.1 requires implementation of FMEA among other systems to evaluate potential failures, their effects, and actions taken to reduce risks. The DataLyzer FMEA module:

• Fully complies to both the old AIAG and the new AIAG-VDA 7-step methodology, including structure analysis, function analysis, failure analysis, risk evaluation, and optimization.
• Includes automatic linkage to Control Plan and Process Flow to ensure consistency.
• Tracks version history, approval status, and change logs.
• This ensures that your FMEA is not a one-time activity but a living document updated throughout the product lifecycle.

 Below image shows an example of an AIAG-VDA FMEA format that can be generated from the DataLyzer FMEA software:

b) SPC (Statistical Process Control)

Clause 9.1.1.2 and 9.1.1.3 focus on statistical tools and statistical concepts to monitor and control process variation. The DataLyzer Qualis SPC module:

• Offers real-time monitoring using industry-standard control charts (X̄-R, X̄-S, p, np, c, u).
• Sends alerts when control limits are violated, prompting timely investigation.
• Supports rule-based interpretations, including Western Electric rules.
• Allows batch filtering, subgrouping, and capability analysis (Cp, Cpk, Pp, Ppk).

Within IATF16949 it is important that your organization responds to out-of-control conditions. The DataLyzer (mail) alert system helps drive proactive, timely and correct actions.

Below image shows how the DataLyzer Qualis SPC software prompts an alert when an SPC violation occurs.

c) MSA and Calibration Management

Clause 7.1.5.1.1 requires MSA for measurement systems while clause 7.1.5.2.1 talks about calibration records. The DataLyzer Qualis MSA module provides:

•  Gage R&R (both ANOVA and Average-Range method), Bias, Linearity, and Attribute Kappa Studies.
•  Both internal and external Gage Calibration studies.
•  Calibration and MSA master list, with tracking of due dates and gage MSA and calibration history.
•  Proper gage management with gage registrations, study reminders, tracking missing/faulty gage statuses and gage supplier management.

d) Audit Trail and Data Integrity

Clause 7.5.3 from IATF 16949 (associated with ISO 9001) requires organizations to control documented information for among many reasons which is also to prevent unauthorized changes. All of the DataLyzer software modules feature:

• Read-only historical data after approval.
• Role-based permissions for editing, reviewing, and approving.

This gives auditors confidence in the validity and integrity of your records.

e) Flexibility for Customer Specific Requirements (CSRs)

OEMs like Ford, GM, and VW have specific formats, rating methods, or risk thresholds. Our DataLyzer FMEA software allows:

• Specific FMEA format templates per customer CSRs.
• Custom severity/occurrence tables.
• Customer-specific FMEA and control plan headers and layout.

By aligning with your customer needs, the risk of nonconformities during CSR-focused audits will be reduced.

Why IATF Compliance Is Not Just a Checkbox but it’s a Culture

While software helps facilitate compliance, it cannot replace quality culture. Auditors are trained to look beyond documentation and ask:

• Are users trained and competent?
• Are risk tools used actively, or only during audits?
• Do you take preventive action, or only react to failures?

That’s why the DataLyzer software is designed not just for compliance, but for day-to-day use and organization-wide implementations:

• Easy-to-use interface encourages frequent updates.
• Configurable dashboards to keep users engaged.
• Modular licensing ensures each team (engineering, quality, production) can use the system appropriately.

Conclusion: The Role of Software in Successful IATF Audits

In an IATF 16949 audit, your software systems come under as much scrutiny as your processes. From FMEAs to SPC charts to gage lists, the structure and discipline of your data systems reflect your organization’s quality mindset.

At DataLyzer, we don’t just build the software tools for you but as your continuous improvement partners, we help organizations build resilience, discipline, and readiness. Whether you’re preparing for your first IATF audit or your sixth surveillance, ensure that your software is not just functional but audit-ready, traceable, and aligned with the standard.

Consider DataLyzer software as a reliable solution to support your IATF compliance journey with confidence and clarity!.