AS9100 and the Actions to Address Risk and Opportunities
As we have mentioned before AS9100 REV D is very much focused on understanding the Risks in your Quality Management System and to your organisation plus how you will handle them. It makes sense, working in the aviation, space and defence industries is risky and the products that come out of those industries are perhaps the some of the highest risk products in the world. The opportunities however are also high.
Clause 6 of the standard is all about Planning, putting in place the groundwork and processes you need to have to make sure you consider the right things when it comes to your systems.
Clause 6.1 Actions to address risk and opportunities
Clause 6.1 - Actions to address risk and opportunities is really focused on helping you do this; it has also got that keyword "SHALL" in the clause which means you must do it to meet the standard.
Clause 6.1 of the AS9100 REV D standard is a change to the previous standard and inline with the changes that happened between THE STANDARD9001:2008 and the 2015 version of the standard which AS9100 red D is based on. It is quite a useful change to be fair, it is all about getting you thinking about how you handle the risks that you have previously identified. Now if you have just jumped in here and you have not been following along then you will want to go back and read the 2 clauses that Clause 6.1 references these are:
- Clause 4.1 - Understanding the organisation & it's context (Context of the Organisation)
- Clause 4.2 - Understanding the needs & expectations of Interested Parties.
From these you will hopefully have done your SWOT analysis or perhaps the full-on PESTLE Analysis, irrespective of which you did you now have a list of risks that you are aware of in the business that could have an impact on your Quality Management System. Now the AS9100 standard wants you to take some actions on them. The easiest way of doing this is to take each of the sections in order (Strengths, Weaknesses, Opportunities & Threats, or the similar sections of your PESTLE Analysis) and review each of the elements. Keep in mind that just because something is a threat to you today it does not mean you cannot turn it to an opportunity and vice versa so do all of them and not just what you perceive as a threat. You may have an opportunity for new work for a new customer or segment, which would be an opportunity. However, taking on that work becomes a threat if you cannot hand the capacity, quality requirements, delivery performance and so forth. It is always best to have someone play devil's advocate as during the process as well.
It is easy to forget you have a range of choices when dealing with risks or opportunities. It is never back and white and the standard wants you to consider things with respect to the following 4 elements:
- How you will give assurance that your Quality Management System will achieve its intended results... i.e. how will you follow through and do what you say
- That "desirable effects" i.e. how will the upsides be enhanced - so more of the good stuff (think Good to Great!)
- Prevent or reduce undesired effects - so less of the bad stuff
- Achieve on going improvement of your systems - yep... it is PDCA time again!
When you are thinking about risks around say threats, think about these things:
- Can you Eliminate what is causing the risk
- Can you Change the likelihood of the risk happening or the consequence/s that occur or the severity of the consequences?
- Can you Avoid the risk altogether?
- Can you reduce it by Sharing the risk with perhaps a partner, a supplier or client?
- Accept that it's just a risk of business so make the decision to Retain the risk by informed decision, i.e everyone knows what the risk is, what the consequences are and perhaps you have a game plan in place just in case it does happen.
- Just do it anyway - Knowing what you know about the risk do it anyway to pursue an opportunity
When you are looking at the upsides and your opportunities think about these:
- Can you Adopt new practices to get the benefit?
- Should you Launch new products to grow a market
- Perhaps you can Open new markets altogether.
- Perhaps you can attract new customers.
- Build partnerships to spread risks at the same time as opening opportunities.
- Use new technology to give you that advantage or save on costs.
The second part of AS9100 REV D Clause 6.1 says that you shall (i.e. you must) to create a plan to address the risks & opportunities that you have identified, you must
- Integrate & implement the actions into your Quality Management System processes.
- Evaluate the Effectiveness of these items.
While the standard does not explicitly state you need a formal document for this you would be hard pressed to say you have done it without any evidence and why wouldn't you want to do this? There are several ways of doing it, but I like the use of a risk analysis template which is easy to use, systematic and easy to track. The idea of the risk template is that you review the risks and opportunities that you have identified as they are, prior to you doing anything.
Then identify the actions you will take to reduce or improve the initial risk number and then based on those steps re-evaluate it based on those steps being complete, has it reduced the risk or improve the opportunity? Then follow through on these things and you tick the box for complying with this requirement and you have a business improvement. You of course should review these as part of the AS9100 quality management reviews, you may review high risks every 3 months, mediums every 6 and lows every year for example but you should certainly plan for that.
We have created a simple excel template that you can use to map out your analysis of your SWOT quickly and methodically so you can both action what you need to but also clearly demonstrate the steps you have taken to keep the auditor happy as well!
Grab our Free Risk Analysis Template
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