Some great questions to ask when performing an audit: 1. What are my biggest RMA (return merchandise authorization) issues? What products come back through my door after shipping? 2. What are the problems I'm solving for my customer? What are my gaps? How many of these gaps are created by my manufacturing technology? 3. What are my most manually intensive and complicated SOPs? (standard operating procedures)

In my experience, defining audit scope , objective and criteria is cornerstone for any audits . Alright, first things first, we need to figure out what exactly we're checking in this audit – the scope. It's like setting the boundaries, deciding if we're looking at inputs, outputs, activities, or maybe just checking if everyone's following the rules. Then comes the objectives, our goals for this audit adventure – could be making sure everyone's playing by the rules, seeing how well things are going, finding cool tricks others are using, or suggesting ways to do things even better. Just make sure these plans match up with what the big bosses and the company as a whole want. Easy peasy, right?

Audit criteria and method are key for any successful audit . Now, let's pick our tools for the job! First up, the criteria – basically, the rules we're playing by. It could be standards like ISO 9001, what the customers want, or just how the company says things should be done. Then, the method – how we're going to do this detective work. Are we reading documents, having a chat, watching things in action, or running some tests? The key here is to make sure our criteria and method match what we decided in the first step – gotta keep everything in sync!

Your Audit Criteria should be driven by the decisions made above. The most challenging thing about testing your manufacturing system is finding a way to create objective metrics that can be sampled and measured. The key to creating your audit criteria is thoughtfully creating your scope and objectives in a way that can be measured. For example saying: 'We wish to audit how well our widget manufacturer meets it's target goals' is not a clear enough objective. A better definition would be 'Currently our widget production line has an unacceptable rework rate, this rework rate is currently estimated at 20%, but the exact value is unknown. This audit will monitor and define the exact rework rate.

What I have seen planning and preparing for audit is imperative for any audits . Time to get our ducks in a row! We're making a game plan – an audit plan – where we jot down when, what, who's doing what, and who's responsible for what. Think of it like a schedule for our detective mission. Then, we need our trusty audit checklist – it's like our cheat sheet with all the questions we're asking and what proof we're looking for. But hey, no secrets here – we're sharing this plan and checklist with the process owner and our audit team, so everyone's on the same page. And before we dive in, a quick peek at the process docs, records, and past audit reports to know the lay of the land. Ready, set, audit!

Ideally you will use an iterative model like Agile or Scrum to drive your audit. Audits are, at their core, and research and development action. You should expect new information each sprint that will improve your decision making throughout the audit. Create a product backlog (the goals of your audit) and use the Agile process to focus on the work you can clearly define. For instance at the beginning of an audit you may focus entirely on interviewing the operators and getting their feedback on the current state of your manufacturing process. Review existing SOPs and document what's actually happening on your production floor. It may take several sprint cycles to create enough information to generate meaningful, actionable, data

Audit to be done per sticking to the plan and using appropriate checklist to gather clues – could be papers, talks, watching how things roll, or some testing action. As we go, we're noting down what's working, what's not (aka nonconformities), any interesting observations, and spots where we can level up. Once we've got our findings, it's not a solo mission – we're double-checking with the process owner and the team to make sure we're spot-on. Accuracy is the name of the game!

Focus on maintaining your product backlog. Each sprint take time to sit with your audit team and discuss what you've learned and how that impacts upcoming work and goals. Focus on fostering an open, inclusive, and judgement free conversation between your team. This allows for everyone to share their perspective. More information means better decisions, better decisions means a better audit. Openness creates a better audit. As work is completed take time to recognize the effort and dedication of your team.

Audit reporting should be properly structured and defined . We're putting together an audit report that wraps up what we checked, how we did it, and what we found – the whole audit story. If we spotted areas for improvement or things that need fixing (yep, recommendations), that's going in too. Before we hit send, our audit report gets a green light from the leader of the audit team and the process owner – gotta make sure it's all good. Then, it's out to the world – or at least the folks who need to know. Audit closed!

An audit report should be a mirror of your Goals and objectives step above. 'We said we were going to do this, this is what happened' should be the basis for the audit. Your audit should exude simplicity and clarity. If it's complicated and the value you created is buried no one will read it. Focus on making it clear that you did what you promised you would do and put the value up front. The 'value' may be insights, recommendations for improvement, areas of strength that were found, etc.