When it comes to manufacturing, quality is usually of utmost importance. This is especially true for industries such as aerospace, automotive, healthcare, aviation, and those where human lives are on the line. We’ve previously blogged about the difference between Standard Calibration (ANSI/NCSL Z540.1) and 17025 Accredited Calibration, and considerations for choosing a calibration provider. While a calibration provider can make a huge difference in your overall manufacturing landscape, there may be times when you need to prepare for a third party equipment calibration audit.
While never fun, equipment calibration audits do happen. Here are four tips to prepare for the audit.
- Do Your Homework
It’s important to understand the scope of the audit and if you’re unsure, be sure to ask for clarification. This will help you define what to plan for – process, calibration, purchasing, etc. The goal is to never be surprised by what an auditor will ask to see. It’s also important to understand the difference between policies, records, and procedures, and be sure that you can produce them.
Begin with the past in mind – auditors quite often begin with the results of a previous audit. Another important thing to do is to make sure you are following your own policies, which is often one of the top sources of deficiencies.
Be sure to read and understand the Standard that you are being audited to and make sure you have a copy (it’s usually required). Then check if there are additional requirements from the Auditing body. It’s always a good idea to understand your “can’s, may’s, should’s, and shall’s,” and be prepared to explain what you do and why should you deviate from requirements.
Utilize a checklist when you can. Some auditing bodies or customers have a checklist they ask you to complete beforehand.
- Gather the Facts and Evidence
Prior to the audit, be sure to gather proof that you do what is required of you; that you do what you say you do. This could include:
- Policy documents
- Organizational charts
- Posted signage
It’s important to understand where certain things are and to “get your ducks in a row.” This might include previous audits, management review documentation, proficiency tests, training records, and environmental data.
Using a calibration program management tool is very helpful in maintaining your records and ensures that requests for information or documentation can be fulfilled quickly and easily. Tektronix customers can use CalWeb®, our cloud-based calibration management application, to store calibration certificates and service records, manage OOT investigations, and track the calibration status of your entire asset pool.
- Prepare the Work Area
There is no need to repaint and scrub your work areas, but there certainly should be some attention to basic housekeeping and orderly storage of materials. If possible, use a computer and project information on a screen or wall for easier review. With that in mind, be sure you know how to use your own systems – make sure you have proper access to documents, that you can navigate the software, and practice these in advance of the auditor arriving.
Provide a short tour of your operation. Introduce members of your team and point out relevant aspects for your process. This tour may likely form the first impression to the auditor(s) as they observe the facility and helps them develop questions and areas to discuss as the audit proceeds.
Prepare for any required performance demonstrations. Needless to say, the more efficient you can make the demonstrations the more professional your organization will appear. Ensure that trained personnel are available, the tools required and units to be tested are prepared and ready to work on, that the records and evidence is collected ahead of time and are available for the auditor as they observe. This evidence might include procedure documentation, budgets, environmental data, and/or certificates.
- Prepare your Employees
The more professional your employees and facility appear to the auditor, the better impression your products and services will show.
- Appearance – Not all businesses have a dress code these days, and certainly suits are not required, but typically logo shirts and clean, serviceable pants and shoes are appropriate and go a long way in reinforcing the idea that your employees take the same care with their work as they do in their appearance.
- Communication – The tone with which your employees respond to auditors and their honesty and openness to answer questions, all contribute to showing your organization is serious about compliance and quality of work.
It’s a good idea to hold a pre-meeting where you can explain the purpose of the audit and what they can expect. You can explain how they should respond to questions and things they do not know that might come up in conversation with the auditor(s). Including them in the opening and closing meetings will help put them at ease and helps make them feel engaged.
Effective audit preparation requires a well thought out plan and understanding of what is being audited, the facts and evidence that you are complying with requirements.
Investing the time to prepare the work area and the employees who will be participating in the audit will help you present your facility professionally and competently. Using these four tips will help you along the way.