Suppose an audit firm in Dubai is responsible for planning and executing audits of a given company. In that case, the auditors know how much effort and planning are required to ensure that your quality system meets ISO and GMP standards. As the quality system matures, specific sites, departments, or processes need more attention. Others may comply with GMP or ISO standards, but they don’t necessarily require as much attention. This indicates that the company should adopt risk based internal audits of quality systems.
An Approach To Value Assessment That Is Risk-Based
An internal audit can be performed using a risk-based approach. This allows the Internal audit function to assess the importance and performance of each area. These results can determine which areas you should allocate your resources and time. It is possible to determine which areas of your business require less supervision based on the results of this risk based internal audits assessment.
Higher product quality is often achieved when risk-based approaches are used. Because trouble areas will receive the time and attention they need to improve, this is a good thing. Risk-based quality audits will enhance your productivity. Entities will be more productive if they spend their time dealing with problems instead of auditing areas that are doing well.
How To Include Risk In Internal ISO And GMP Audits
Assess Organizational Risk
When assessing risk, internal audit services Dubai agents should take into account various departments and processes that are audited regularly. Each of these areas may be quantified as you go. You can also use traditional risk analysis tools such as hazard analysis, fault tree analysis, failure mode effects criticality analysis, and hazard analysis. There are many factors to consider when assessing risk.
Risk to Quality and Patient Safety
Classify each department/process based on how important it is to produce safe, high-quality products.
Look at the history of recalls and nonconformances. Areas with more incidents should receive a higher risk score.
Go through past recommendations to determine if there are any gaps in regulatory requirements. This applies to all countries that have market approval. This score can assess the extent of corrections made in audit observations. After taking into account all of these areas and any other risks specific to your company, you can combine their risk scores to create an overall score. This will allow the internal audit firms in UAE to identify high-risk regions quickly and help you make an audit plan. You must keep this written record of your assessment.
Include Risk In Your Audit Plan
As you rank each department’s risk, you’ve probably already begun to create a mental picture of your audit plan. Now it’s time to review each area and its associated risk score. Planning is only as good as your audit schedule. Audits in high-risk areas should always be done more often, at least annually, but sometimes more frequently. Low-risk regions do not require an annual audit. Based on your risk assessment, you will need to set a schedule for each department and a frequency.
Your audit plan is not the only thing that could be at risk. These include the length of the audit and the skill and size of your audit team. Audits in high-risk areas will likely require more prolonged and more detailed audits. Internal audit companies in UAE with special skills or knowledge may be needed for complex products and processes.
Perform Risk-Based Audits
You don’t have to make your audit plan risk-based. Once you have chosen an area to audit, you can use risk-based approaches in each audit. Examine the procedures within each department. This is the first step. These documents will help you understand the high-risk processes and help you to focus on your questions. To determine if the information from previous audits can be used in your next audit, you should review it. These items should be checked:
- Previous audits: observations
- Past corrective action plans and their effectiveness
- Areas that were not previously examined in audits
- This department is responsible for recalls, adverse events, and defects
- Since the last audit, there have been personnel or process changes.
These areas will help UAE companies identify potential areas of concern. This will help you focus your questions and maximize your time auditing.
Follow-Up On A Risk-Based Base
Once the audit is completed, you will make any recommendations or findings. Follow-up will be done using a risk-based approach. To help you decide which results need immediate attention, we will give each finding a risk level. This will enable you to respond faster to critical findings than if they were only followed up in the order received. For high-risk results, CAPA can be initiated. Audits can be quickly resolved for low-risk issues.