The auditor cometh

Think of your favourite restaurant. You love going there, you get takeout from it all the time, the staff know you and your order when you walk in the door. Have you ever been in the kitchen? What if you had the right to look through the kitchen, poke around in the refrigerators, check the rat traps and read the recipe file? Would you do it? Would you want to do it?

When you’re in chemical manufacturing, customer audits are a normal part of life. It’s in each customer’s interest to know that the chemical plant that is supplying them with crucial inputs isn’t shabbily put together or could be shut down by the local authorities as a hazard at any moment. If you’re in the pharmaceutical industry, your country’s regulatory agency requires the drugmaker to audit its manufacturers. You don’t know when the auditors are coming, and what questions they will ask, but you know you will inevitably get an email telling you that the quality assurance department of one of your customers is requesting an audit. While there is some availability to negotiate dates, the auditors will definitely show up at your door in the near future.

There is always a great deal of preparation in a plant before the auditors arrive. While quality auditors don’t focus on the cleanliness of a chemical plant in their inspections, the old joke about bathrooms in restaurants applies. First impressions matter, so neatness is the order of the day. There is no need for spit-shining the reactors, but a scrubbing of the floors, a decluttering of the plant floor and a tidying of the warehouses is a good start. The laboratories don’t escape the cleaning ritual either – a good quality control laboratory always looks clean, but it seems that it sparkles the morning of an audit. While the auditors won’t open every single door, they will definitely look around their environment and ask good questions – so being prepared with answers is important.

There is an art to providing sufficient information to answer their question without accidentally generating more questions to be asked

When the auditors arrive, there is typically an introduction meeting, and a laboratory and plant tour. After that, they will choose an aspect of the plant to scrutinise. What they tend to spend the most time doing is comparing the written procedures in a plant with the actual records of the chemistry being performed. These discussions typically take the form of a series of straightforward questions from the auditors. ‘Can I see the production batch record for this product that we purchased from you?’ ‘It says here that tetrahydrofuran was used for this product – what quality control do you have for this solvent?’ ‘I see that the manufacturing procedure was performed by Jane – can you show me Jane’s training records demonstrating that she is qualified to perform this procedure?’ There is an art to providing sufficient information to answer their question without accidentally generating more questions to be asked. If you have a weakness in your procedures, it might be wise to clam up a bit, but a smart auditor will sense your reticence and ask even more questions.

Different auditors have different aspects of the plant that they focus on. Some of them may come from a manufacturing background, so they want to spend a lot of time in the plant, understanding how you manufacture their chemical compounds and what quality concerns could arise from your typical practices. Some have laboratory experience and spend a great deal of time making sure that the testing procedures make sense, that the equipment is well-maintained and well-calibrated and that the chemists are properly trained. While sometimes this is a tedious and perhaps even painful process, it is an important evaluation of a company and its manufacturing procedures.

When the auditors leave, there is often a sigh of relief as they walk out the door. But that is not the end of the process! The auditors will issue a detailed report that describes what they observed at your plant, and what they would like to see improved. If it is bad enough, they will recommend that their company demands a fix before they issue another purchase order to you. When they are purchasing a chemical, they are purchasing more than compound in a drum – they are also purchasing the quality of the material, which cannot be written into specifications.

You’ll write up a response to the report, detailing the requested changes that you’ve made to your equipment and your processes. In the mundane sense, you’re checking off action items off a list, but in reality what you’re doing is making small improvements to your plant. The customer comes out of this with a better quality product, and you’ll come out of it with a better quality plant.