What is an AS9100 Gap Analysis?
If you are looking to implement the AS9100 Quality Management System (QMS), one of the first things you should do is compare your current (QMS) to the AS9100 standard. This is usually called a Gap Analysis. It is important to understand what the Gap Analysis involves, and what information it will provide.
The most important tool for the Gap Analysis is the Gap Analysis Checklist. This is a list of the requirements in the standard, written in question format. The Implementation Team will use this list to compare the QMS that is in place with the standard requirements. When using this checklist, the organization provides recommendations of what documents should be looked for, examples of what will meet the requirements and other guidance on creating a QMS that meets AS9100 standard.
When you use the gap analysis, it becomes the roadmap for your QMS. The gap analysis will allow you to see what areas of your existing QMS (if you have one) are acceptable and which ones need revision. The implementation team now knows where to focus their efforts.
Once you complete the checklist, you should use the information to make a task list for your organization. For each section of the standard, you will want to prepare a list of items that need to be implemented, redesigned, or documented.
- Every question on the checklist can be answered with comments stating what is in place or what is not in place.
- Make notes explaining what practices do not meet the standard.
- Make notes on where additional documentation is required.
- Make other observations relating to compliance with the standard.
The team must be familiar with the standard in order to perform an effective audit. If your team has not been trained on the AS9100 requirements, be sure to provide training before performing the gap analysis.
Scheduling and Conducting the AS9100 Gap Analysis
Scheduling the Gap
- Review the project plan: Who did you identify to conduct the gap?
- Determine if you will review by process/procedure or by area of the facility. Our approach is usually to audit by process/procedure and compare.
- Schedule time to review each section of the standard.
- Arrange your Gap Analysis checklists so each member will have the sections of the standard that are applicable in the areas they will cover.
Conducting the Gap Analysis
- Follow the schedule that you have prepared. Review each process/area of the facility to evaluate the current quality system.
- For each requirement (or set of requirements) of the standard you will want to identify the status of the current system.
- Focus on what is in place, and what is not in place.
- Remind the team that you are not focusing on compliance or non-compliance with the current system, but on the design of the current system, and if/how it matches the AS9100 requirements.
- Note what is in place, and what will need to be developed and changed.
- Take complete notes, reference documents and examples.
Reporting
Summarize the audit findings in the form of a task list. You will usually identify several categories of tasks:
- Processes that comply with the standard and are documented.
- Processes that comply with the standard and must be documented.
- Processes that do not comply with the standard and must be redesigned.
- Processes required by the standard that are not currently in place.
When the gap analysis has been completed, meet with the team to summarize the results:
- This meeting should be held shortly after the review, so that information is fresh in the team’s memory.
- These results can be transferred to task lists for the implementation.
- Task Teams will be assigned responsibility for the development of a procedure.
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