Most audit failures aren't about process gaps. They're about documentation that doesn't reflect reality. Here's the checklist we wish existed before our first Rev D audit.
When AS9100 Rev D replaced the previous revision in September 2016, it introduced one of its most significant and least understood changes: the replacement of "documents and records" with the single term "documented information."
This was not a terminology change. It was a signal about how the standard thinks about documentation in a modern quality management system — less focused on document format, more focused on whether the right information exists, is controlled, and is accessible when and where it is needed.
If you have been preparing for a Rev D audit using documentation practices developed under Rev C, this is the first thing to understand: auditors are not just looking for documents. They are looking for evidence that documented information is created, updated, and controlled in a way that supports consistent process execution.
When an auditor begins their document review, they tend to start with the same set of evidence. Not because these are the only requirements, but because they are the areas where findings are most common.
Quality Management System Scope — Clause 4.3 requires a defined, documented scope. Auditors want to see it, and they want to see that it accurately reflects your actual operation. A scope broader than your processes is a finding waiting to happen.
Quality Policy — Clause 5.2 requires a documented policy that is communicated and understood at all levels. Operators at the process level should be able to explain what it means for their specific job.
Quality Objectives — Clause 6.2 requires measurable objectives with evidence of monitoring, ownership, and documented review history.
Risk and Opportunity Register — Clause 6.1 requires documented actions to address risks and opportunities. One of the newer requirements and among the most commonly missing.
Process Documentation — Core manufacturing and support processes need documented information sufficient to demonstrate consistent execution: work instructions, control plans, and process FMEAs for aerospace applications.
Competence Records — Clause 7.2 requires evidence that people are competent to perform their roles. Training records and qualification matrices need to be current and traceable to actual persons and processes.
Calibration Records — Clause 7.1.5.1 requires documented evidence for monitoring and measuring equipment. Auditors spot-check specific equipment used in critical processes.
Documented Procedures for Key Processes — Internal audit (Clause 9.2), management review (Clause 9.3), and nonconformance control (Clause 10.2) all require documented procedures.
Customer-Specific Requirements — Any specific customer quality requirements incorporated into your QMS. Auditors check whether these are documented and whether your processes reflect them.
Design and Development Records — Clause 8.3 has extensive documented information requirements if design activity is in scope.
Supplier Evaluation Records — Clause 8.4.1 requires documented evidence of supplier evaluation, selection, monitoring, and re-evaluation. Auditors typically pull three suppliers and look for evaluation evidence.
Internal Audit Results — Clause 9.2 requires documented results of internal audits and corrective action follow-through to closure.
These patterns appear consistently across AS9100 Rev D first and third-party audit reports. Address them before your auditor does.
The single most common major finding in manufacturing process audits. The procedure says one thing. The process does another. Often the difference is a small engineering change that updated the drawing but not the work instruction. Sometimes it is more significant.
The fix requires a systematic review cycle, not just reactive updates when something obviously changes. At minimum, work instructions should be reviewed annually against the current revision of all referenced drawings and specifications.
Many organizations have document control procedures that technically meet the standard but do not work in practice. Operators work from printed procedures that may or may not be current. There is no controlled distribution, no obsolete document retrieval process, and no verification at the point of use that the instruction reflects the current revision.
Auditors do not just check that your document control procedure exists. They ask operators which revision they are working from and whether they know how to verify currency.
Equipment used in critical measurements needs calibration records. Auditors identify equipment in use, look for calibration labels, and ask to see records. Lapsed calibration on equipment that was in use is a finding. Undefined calibration intervals are a finding.
Training records exist. Qualification matrices exist. But neither is clearly linked to specific process requirements. An auditor wants to trace a specific manufacturing step to a specific competence requirement, to a specific person, to documented evidence that the person demonstrated that competence.
With four weeks before an audit, this structured approach addresses the highest-risk gaps.
Week 1: Conduct a documentation inventory. List all procedures, work instructions, and records required by your QMS scope. Identify gaps and currency issues. Prioritize by audit risk.
Week 2: Resolve the highest-risk gaps. Focus on manufacturing process documentation, calibration records, and competence records for production personnel — the three areas auditors examine most closely.
Week 3: Run an internal process walkthrough. Have a QE follow the documentation at each station and identify anywhere operators are deviating from, supplementing, or ignoring written procedures. These gaps will surface as findings if the auditor walks the floor.
Week 4: Conduct a focused internal audit using the AS9100 Rev D requirements directly. Audit to the standard, not to your procedures.
The goal is not perfect documentation in 30 days. It is documentation that accurately reflects how you operate, with operators who can demonstrate they understand what the standard requires.
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