Audits of quality are an essential instrument that can support the expansion » S4 Network
by on 17. May 2022
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When we hear the word "audit," the vast majority of us likely experience a wide range of emotions. It's safe to say that this is the case. For some of us, the thought of hosting an audit causes feelings of dread; for others, it may cause irritation or boredom; and for a very small and strange percentage of us (raise your hand! ), it causes feelings of excitement. For some of us, the thought of hosting an audit causes feelings of dread; for others, it may cause irritation or boredom. Whether the prospect of hosting an audit fills you with dread or annoyance, there are simple steps you can take to ensure that the quality audit you conduct goes smoothly and creates pleasant memories for both you and your organization. These steps can be taken regardless of how you feel about the prospect of hosting an audit.

1. Familiarize yourself with your auditing firm.

Before you begin an inspection, you should always make sure that you are familiar with your target audience. Audits of your company can be conducted on your behalf by your clients, the government agencies that regulate your industry, notified bodies, or even your own employees. Having an understanding of each of these personas will help you better prepare for each scenario if you use it as a reference point.

For instance, a client who is conducting an audit of you as part of the Quality Agreement may choose to delegate one of their employees or hire an independent contract auditor. This choice is made in accordance with the client's preferences. Contract auditors will most likely look for as many nonconformities as they possibly can in order to demonstrate their value to their client. This is the most likely course of action for contract auditors. However, customer personnel will be especially interested in the processes and products, and they may have questions that are more technical in nature.

2. Conduct a pre-inspection walkthrough of the property.

It is imperative to keep in mind that taking the time to walk through the facilities that will be audited is always beneficial and should never be overlooked. ISO9000 Quality System Audit is still beneficial to go through the space with the eye of an auditor and see if there are any things that stand out, even if you are already in the production area on a regular basis as the host. This is because there may be things that have been overlooked.

Carry out the tasks that an auditor would normally do, including verifying the documentation that is currently in use, examining the labels of all of the equipment, and ensuring that everything is stored in the correct location. Following the walkthrough, a note containing any recommendations or issues that were found during the inspection and need to be fixed should be sent to the supervisor of the area. You will feel more at ease throughout the audit as a result of this, as it will prevent a few potential observations from being made during the process.

3. Conduct Instructional Sessions for Your Participants

You should organize a standardized training session on the most effective procedures for audit preparation if you anticipate having multiple people participate in the audit that you are hosting. This will ensure that everyone is on the same page. This training should include best practices for responding to audit questions, interacting with an auditor in a courteous and professional manner, as well as guidance on how to explain technical topics to auditors who are not technically savvy.

You will, after some period of time, be able to determine the key personnel from each function who are best suited to participating in audits. This will be possible because you will have had some time to do so. These teammates will be the best representatives of your organization, and when the time comes for audits, they will become the representatives you turn to most often for assistance.

4. Be conscious of the areas in which you struggle.

When they are carrying out audits, the vast majority of competent auditors use procedures that have been standardized. One strategy that can be utilized is to conduct a review of the processes and look for connections or threads to follow. It is possible that it will start with the review of a training record, which will then lead to the realization that an operator was not trained on a particular procedure on the date that was originally scheduled for the training. As a consequence of this, the auditor will frequently inquire as to the whereabouts of the batch records that are associated with the run in which the operator participated. The auditor may then find out that this batch was used in the validation of a new piece of equipment, which may then lead her to review the validation package itself, where she may find that important documents are possibly missing. Alternatively, the auditor may find out that this batch was used in the validation of a new piece of equipment. After that point, the routine of pulling the thread will proceed in the same manner as before.

Even the most prosperous companies have some facets of their operations that could use some work. When it comes to dealing with high-risk areas, there are two different approaches that can be taken. The first method is to have an honest conversation about them with the auditor during the first meeting that is being held to discuss the audit. Open and honest communication is likely to receive favorable feedback from the vast majority of auditing professionals. The second method is to take precautions to ensure that high-risk areas do not fall within the scope of an auditor's ability to pull any of the threads. This is the approach that is recommended when there are multiple high-risk areas involved. This is not an impossible task, but it does require thorough preparation on your part and careful planning before you can accomplish it.

5. Make the process of preparing for audits an integral part of your overall quality culture.

Despite the fact that it has been overused numerous times, "always audit ready" remains a significant catchphrase in the quality sector. For businesses that perform at least one regulatory audit, 40 customer audits, and regular internal audits on a yearly basis, the question of whether or not they are always audit ready becomes a matter of frequency. Adopting this mindset will assist organizations that conduct fewer audits in cultivating a culture of quality and instilling the idea that nearly every aspect of every role may one day be subjected to inspection by an auditor. This will allow the organizations to make the most of their limited auditing opportunities. This is especially important for organizations that are not very large.

It's possible that the word "audit" will never cause anyone to feel anything other than cold and detached. On the other hand, if you put these five recommendations into action, you will start to think and feel positive things whenever the word audit is mentioned. If you adopt this mindset, you will be able to approach the subsequent audit of your organization as a constructive opportunity for the ongoing enhancement of its operations. If you do not adopt this mindset, you will not be able to approach the audit in this manner.

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