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This post outlines the value of the Stage 1 Review in conformity assessment. Given that things are changing, temporarily you’d hope. it looks like an increasing number of these will be conducted remotely. In principle I have no issue with this, provided the integrity of the activity can be maintained, and it continues to be fit for purpose. The Purpose of the Stage 1 Audit The Stage 1 Audit is often referred to as the readiness review. Once a 2nd or 3rd party body has determined how many days will be appropriate for the audit, they will invariably set aside 1 day for this readiness review, and program in the remaining days usually a week or so later, but conditional on the outcome of the Stage 1 Review. Possible Outcomes? The possible outcomes are to either proceed as planned with the Stage 2 Audit, or delay. The choice should actually be an easy one. Any major nonconformances will lead to a delay, minor nonconformances won’t. Major nonconformances suggest major weaknesses, significant corrective action and usually a period of implementation and further accumulation of evidence of conformity (records). Not the sort of thing that can be corrected within a few days. Effectively the auditor is telling the auditee that it would be a bad idea to proceed as planned as the outcome right now would not be a good one, however delaying the Stage 2 Audit for some weeks could meet with a more favourable result. You Can’t Look At Everything Stage 1 Audits are short preliminery reviews of general readiness. You simply haven’t got time to look at everything or to examine records in any detail. You are merely determining that a deep dive won’t be a waste of time, and when you ask for certain things, the auditee will be able to produce something worth looking at. So the auditor has to be selective and identify the documents that are the main building blocks of the QMS (for example significant Planning documentation), and also to identify the records that give the best indicator of a fully implemeted PDCA based QMS. So Which Records? You can’t look at all records because you don’t have time, so you need to be selective and focus on the elements of the QMS that will be the best barometer of whether the system is implemented and working, so what would that be? Well, thinking logically, the PDCA cycle is both sequential and iterative. So which quarter would give the best indicator the loop had been closed? Well, the LAST loop of course, which maps onto Sections 9 and 10 of the standard. These are the records you really need to see. If there is a good body of Check-ACT” records, we have a closed loop. And Onto The Plan You don’t need a Plan to conduct a Stage 1 Audit. You are invariably working only with one person (the system manager) with whom you need an appointment, but as you aren’t moving around and disrupting any work activities, you don’t need a plan. Stage 2, however, will need a plan, so one of the additional tasks for the auditor whilst conducting the Stage 1 Audit, is to gather any and all significant practical and logistical issues that will affect the Stage 2 Audit Plan. The first thing I ask is how long is induction? If my team will be expected to watch a mind numbing 40 minute video about walkways, sirens, smoking and skips, I need to know, otherewise we’ll be one hour behind in our plan before we start work on day 1. The Future? Many years ago, the old Document Review”, where you’d be sent a load of hard copy documents in an envelope and you had to try to take a reading off the contents, it would be quite common for that readiness review to give a false positive. When you have boots on the ground and you can see things and people, clarify etc, its much more reliable. These days technology offers many additional ways to more reliably perform a readiness review without necessarily being on site”, so I have no real issue with it. Stage 2, on the other hand, where you need to establish conformity to all of your Section 7 and 8 requirements? Much, much less so … Posted in 9001 Lead Auditor Study Group , Auditing | Tagged auditing , ISO 9001 audit , stage 1 audit | Leave a comment A Few Collected Wisdoms (updated for 2022) Posted on December 30, 2019 by Shaun A few things I’ve learned I get asked regularly to give advice on setting up a new business, changing career and so on, having been through the process and, to all outward appearances, made a decent fist of it. I’ve survived for 14 years on my own now. You can get the basic advice on the mechanics (getting an accountant, bank account, registering at companies house etc) from anywhere, and I am the last person you’d go to for advice on personal admin – but that’s the easy part. The hard part is knowing what will work and what won’t, what will help and what will be a waste of time, how to keep thinking clearly and so on. So, to that end, I have decided to post a collection of my own personal experiences that are a product of 20 years trial, error and, in some cases, bitter experience. They are in no particular order. I do this so you don’t have to Don’t sound like a snake oil salesman Be careful with the copy on your website and in your other communications. Try to avoid corny cliches and general boasts about your expertise. Anybody can say things like our consultants are seasoned industry experts with unrivaled experience” or whatever. ANYBODY can make that same boast. They’ll say if if it’s true, and also if it isn’t true. That’s why it’s a waste of space on your website. It could do more harm than good and at best will just get tuned out by visitors as white noise. Try to say things that other people can’t say and qualify them with specific examples. Why do you think I write these blogs, and the occasional article for the CQI and IOSH? It builds trust, hopefully adds some value to the reader (free of charge) and gives specific examples. I use case studies and (where I have permission) name names. The bottom line with that being judge me by the company that I keep”. Oh, and always (try to) tell the truth. It’s always better in the long run. A good liar also needs a good memory. 2. Writing in your own voice People that have met me sometimes say that when they read my blogs, emails and even my training course notes, they can hear the words coming out of my mouth. I’ve somehow learned to write the way that I speak. It’s a way of writing that is consistent with the way I am in person. There are a couple of advantages in doing this. First, it stops your material reading like you’ve copied and pasted it. Second, people like consistency, people trust consistency. I’m not a natural writer and it took me a while to find a style of writing that I could actually make work. I don’t use a lot of adjectives and my writing isn’t stylish or flashy, I’m just not good enough with vocabulary to do that. I write in short sentences and I try NEVER to use a word I wouldn’t use in everyday speech. Ask somebody else to read...