What is an AS9110 Gap Analysis?
Scheduling and Conducting the 9110 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 to the current system, but on the design of the current system, and if/how it matches the 9110 requirements.
- Note what is in place, and what will need to be developed and changed.
- Take complete notes, reference documents and examples.
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 teams memory.
- These results can be transferred to task lists for the implementation.
- Task Teams will be assigned responsibility for development of a procedure.