It’s a daunting feeling leading-up to an assessment, and there are many questions that may cross your mind.
“Are we ready for the audit?”
“I wonder how we are going to do.”
“What if I forgot something?”
As many QA professionals will tell you, the question of audit readiness is a bit of a misconception. Try as we might, there is little that can be done to influence outcomes as the audit approaches. The reality is that audit results are baked into your records well before the assessment begins. The best you can do is trust that your system is implemented properly and have faith that the evidence will support it.
Nevertheless, there are several prep activities you can do to help make the assessment go as smoothly as possible and get your team positioned for success with any post-audit activities. Here are a handful of tips you may find useful when preparing for an assessment:
1. Revisit the Criteria
There is no need to quote chapter and verse when it comes to ISO standards or your quality system. Simply having a good grasp of the relevant checklists and documentation will be beneficial towards the audit. That includes supplemental criteria like traceability, logo use, and proficiency testing checklists. Again, no need to memorize these, but knowing how to navigate them and how they are relevant is key. Depending on your organization’s structure, you may ask key personnel to spot check standards/methods and any supplemental criteria.
2. Survey Your QMS
Take time to review the major components of your quality management system and confirm that records are easily retrievable. There is no need to perform another internal audit here but reacquainting yourself with the system’s major processes and outputs will help with recall and retrievability when you’re working with assessors. To that end, review your organization’s most recent internal audit and management review. Get a sense of the continuity between your organization’s various processes and what has transpired since the last assessment. Be prepared to speak about any changes to your management system due to internal/external impacts including corrective and preventative action, and review items like risk analysis, customer feedback and complaints, and nonconforming work investigations.
3. Survey Test Technologies
Check record availability for the test technologies (categories of methods) on your scope and confirm that records are easily retrievable, including records on equipment/calibration, maintenance and facilities, and validation activities. To further your success, don’t forget to check validation records for any instrumentation that utilizes user-developed or modified software.
4. C025 – Cross-Reference Document
This document acts as a roadmap for your assessment. Make sure your C025 cross-reference is up to date with current record and documentation references. You and the lead assessor will be referring to this document throughout the assessment process. The more effort and detail you put into the cross-reference, the more it will come in handy during the assessment.
5. Scope Expansions
Check in with your lab managers and identify any proposed scope changes prior to the assessment. Notify your Accreditation Officer and A2LA assessors of any new/revised standards or methods you wish to add to your scope so that they can budget for that time in their assessment agenda. Be sure to have relevant records in place to support any scope changes such as training records, equipment/calibration records, work instructions, report templates, and evidence that your organization has rights to the standard. Doing a quick comparability analysis and helping the assessors understand similarities between new methods and your existing scope is also very helpful.
6. Set Expectations
Work with your team to set their expectations for the assessment. A quick review of assessment processes and auditor methodologies (document review, interview, witnessing) will help them understand the process and hopefully help calm any anxieties before the audit. Most of all, assure them that no one will be taking blame for individual deficiencies. Ensure they understand that the objective of the audit is to evaluate your organization’s conformance with the criteria and, that among other things, its intent to promote continual improvement of your activities. This communication is worth emphasizing regardless of whether your organization is made up of new recruits or industry veterans.
7. Don’t Stress!
Have a good attitude about the assessment and try to accommodate assessor requests as best you can, while also thinking about the needs of your organization. Think of yourself as a mediator between the audit team, the criteria, and your organization. Make sure your organization’s work is presented and reviewed fairly, and don’t be discouraged if you run into a disagreement or two along the way with assessors. Disagreements happen. Deficiencies happen, too. What is important is showing that your organization’s system is resilient enough to overcome those issues via corrective actions and a positive QA culture.
8. Additional Resources
A more formal description of the entire accreditation process, including audit preparation, can be found here: I105 – Typical Steps in Preparing for the Accreditation Process.