If you’ve received a request for an audit date from a new customer – that’s great news. You’re on your way to securing their business: you’ve passed the initial checks, the finishing line is edging closer and you’re on the home straight.
Once upon a time, the need for an audit might have been seen as a tick box exercise. You could safely assume the customer saw your quotation prices as reasonable, your pre-audit documentation ticked all the right boxes and so, the final hurdle needed to cross the finishing line, was the audit.
That was then. Now expectations are higher and standards higher still: the regulatory environment is much tighter and quality has a much bigger role to play in the vendor selection process. Companies are empowering their quality departments to play a key role in the vendor selection process.
It is common for in-house teams to feel nervous at the auditing stage. But stop, take a breath and remember, more often than not, the auditor is not there to catch you out, to make a mountain out of a molehill, or to launch a Spanish inquisition on your team. Simply, they want to make sure you have the expertise and compliance levels required to carry out the work they’re commissioning.
That being said, this is not always the case. There are occasions when you do get a difficult auditor. When this happens, keep your cool. You can challenge findings if you have a strong counter position.
Prior to the inspection, research the auditor. Check LinkedIn, see if you have mutual connections. This not only gives you the chance to see if they have any particular areas of expertise but it can also help to build rapport. Equally, make sure you know the scope of the audit. Sometimes an auditor can be dropped in at the last minute and change the scope of the audit. You need to be confident that the scope is clearly understood by all parties.
For some service providers, audits are regular occurrences. This can be for new customers and also surveillance audits for existing customers that happen on a continual basis. Either way it places a burden. It’s the opportunity cost of doing business but if you are taking QA out of their day-to-day role to prepare for audits, be available on the day and follow up on CAPAs, it can take up a huge amount of resource. If you don’t have many audits, you’re often preparing from scratch and winning the business can be vital to your company’s balance sheet.
The key is to stay calm. More importantly, the best way to prepare is to always be prepared. Make sure you do regular self-inspections and gap analyses. Ensure these are done by someone not involved in the nitty gritty of the quality management but someone who is independent from the quality system. This will give unbiased findings. If the findings coming out of these are not wholly positive, fix the findings and repeat the self-inspections. Consider hiring a trusted independent consultant to complete a mock inspection and gap analysis. This will give you both peace of mind and confidence that you are up to standard.
Sometimes, the biggest mistake can be complacency. Just because you are being inspected by a regular customer, or an auditor you are familiar with, don’t just assume it will be a walk in the park. Don’t assume that you can have a long non-working lunch or feel comfortable that they won’t check documentation in depth. Auditors can change last minute and you never know what internal pressures they are under. An existing customer will know where to look. Prior to the inspection, review significant changes and deviations relating to the customer so you are familiar with the details and status of associated CAPAs.
First impressions count. It is also important to ensure senior management are in the opening meeting / lunch / close out meeting to reinforce the overall company’s commitment to quality. Remember to also prepare your team for interviews. Auditors will most likely tour your facility and they will want to meet the team performing the work. They will nearly always review training files, sometimes at random, and want to speak to the owner of the file. If your team can speak confidently and comfortably with the auditor, it will reflect well on you.
Throughout the audit, if you do not know an answer, be honest. There is nothing more obvious than when someone is trying to cover up their lack of knowledge. Tell the inspector you are unsure and need to consult with the Subject Matter Experts (SMEs) and come back to them. Most inspectors understand this and will give you adequate time to respond.
One of the big issues faced, is managing confidentiality. Companies often struggle with balancing protecting confidentiality and being helpful. Whilst you can’t show an auditor sensitive documentation, do not be difficult. Where possible, have generic examples of change controls, deviations and CAPAs at hand to demonstrate how your systems work. Being able to demonstrate compliance beyond the SOP breeds confidence and builds up trust.
Finally, expect to receive findings. It is very, very rare in our history of auditing and being audited that we experience absolutely no findings. Every auditor will provide recommendations – even if you are achieving the gold standard. Each auditor has their own interpretation of the same regulations. Do push back though if you think a finding is unfair or purely opinion. If you’re receiving many audits, you can’t adopt every preferential idea an auditor presents. If you are confident in your approach – say it.
If you receive a major finding, again do not panic. It is not great but at least it has been found and you can action the problem. Follow the CAPA plans and provide the auditor with CAPA evidence that this has been fixed.
By keeping good communication and following any action plans, it shows the auditor that you are proactive and have the expertise to deal with issues efficiently and effectively. Doing this you will make your client feel comfortable in their decision to recommend approving your facility.