Every manufacturing organization has codes of conduct and standard operating procedures that define how businesses carried out their operations.
And while a lot of these processes are developed internally, there also exist compulsory regulatory standards that manufacturers need to comply with.
All these regulations are put forward by government authorities and are legally binding.
Consequently, any manufacturing company that doesn’t comply with these regulations could face legal repercussions.
This is why an audit usually takes place.
What is Compliance Audit?
A compliance audit is an assessment of whether an organization is following these standards.
The compliance auditing process involves the organization’s policies review, procedures, files, processes, and documentation to determine whether they are in alignment with regulations in that industry.
Also, please take note that, a compliance audit is not the same as an internal audit.
It’s true that they use the same working principle but, they serve different purposes.
Types of Compliance Audits
A variety of regulatory compliance audits are required by law. It is important for a business to be knowledgeable of what these regulations entail, what they include, and the effects that they will have on the organization.
There are many types of compliance audits, each with its own purpose and methods.
The below part provides an overview of the most common types and how they can be used to ensure compliance with regulations.
HIPAA (Health Insurance Portability and Accountability Act):
Industries involved with healthcare, such as health insurance and providers, are regulated by HIPAA. Via HIPAA audits, standards of care can be enforced to help maintain the security of patient information and prevent any fraudulent use or abuse of sensitive information.
ISO (International Organization for Standardization):
You can make sure you are meeting the requirements of world-recognized standards by adhering to ISO standards. These may include a range of different standards, such as ISO 9000, ISO 45001, ISO 31000, and many others.
GDPR (General Data Protection Regulation):
GDPR compliance is a business abiding by the European Union’s data privacy and security law. Steps to comply with GDPR are planning, analyzing gaps in the current process, remediating those gaps, and assessing what new processes were put in place after the compliance audit. GDPR compliance promotes better data security that increases customer trust.
Top 5 Reasons Why Companies Should Perform Compliance Audits
Below are five compelling reasons to audit your organization’s compliance:
1. Improving Organizational Security
A comprehensive compliance audit can help identify and prevent unauthorized access to data, systems, and networks. It can also help detect and prevent malicious behavior or cybercrime.
2. Detecting and Preventing Illegal or Unauthorized Activities
A compliance audit can help identify and prevent potentially illegal or unauthorized activities, such as insider trading, money laundering, or fraud.
3. Protecting the Company's Reputation
A successful compliance audit can improve a company’s public image and protect its intellectual property rights. It can also help avoid legal actions from government officials or other third parties.
4. Maintaining Regulatory Compliance.
Many government regulations require companies to conduct periodic compliance audits to ensure that their operations comply with specific regulations.
5. Enhancing Operational Efficiency and Effectiveness.
A comprehensive compliance audit can help improve operational efficiency by identifying problem areas early and implementing solutions quickly. It can also improve the effectiveness of your business operations by ensuring that your policies and procedures are effective.
Conduct Compliance Audit: Step-by-step Guide
The compliance audit is an important tool to help ensure your business is in compliance with all applicable regulations.
A well-executed audit can help you identify areas of potential risk and improve your overall compliance posture. Here we provide a step-by-step guide on how to conduct a compliance audit.
1. Decide On Who Will Conduct the Audit
Ensure an audit is conducted smoothly by assigning someone in your organization to be the auditor. It can be a compliance officer, a third-party vendor, or one from your organization.
2. Identify your Goals Before Starting the Audit
State the compliance issues that have been addressed in compliance audits before. If there have been multiple audits, then mention any case which had significant results and use it as a guide to creating audit plans.
3. Collaborate with Relevant Stakeholders:
Be sure to consult people or stakeholders before beginning your audits because this will ensure that your audit is fair and carefully controlled. You should also specify the scope of your audit to maintain consistency and efficiency.
4. Analyze Existing Processes
Look at the company’s current practices, and evaluate them against best practices. Look for any gaps that need to be addressed or procedures that don’t conform with regulatory requirements.
5. Rank and Prioritize Risks
Start by assessing the level of identified risks and determining your organization’s readiness for each risk. From there, prioritize those that will have a significant impact on your business if not properly addressed. Give each risk an appropriate response plan and gradually work on the remaining risks until all risks are managed.
6. Implement Process Changes
Ensure that the changes for improvement that were identified are observed by some part of the organization. Push through and monitor them to ensure they are being followed.
Digital Checklists for Conducting Compliance Audits
Digital checklists are the most basic tool used by manufacturing organizations to maintain quality standards across your organization. Checklists involve checking off a list of essentials manufacturer of a product.
In recent times, digital quality control software has been gaining significant momentum in the manufacturing industry. Digital checklists can be used to manage numerous conduct for various compliances like HIPPA, GDPR, internal audits, and more.
We at Axonator have already created numerous checklist-based mobile apps to help manufacturing companies comply with regulatory norms. Here are some examples:
Axonator for Implementation of Compliance Audit
The best idea recommended to organizations of any size is, to implement a digital platform to perform a compliance audit. This will help you to comply with numerous regulatory requirements and standards. This will save a huge manual process effort from paper-based data collection to analytics, report generation & monitoring.
Aside from helping companies in compliance, it can also streamline other processes like inspections, maintenance, audits, compliance, and more. Numerous industries and organizations use Axonator to automate field workflows, thereby achieving digital transformation in record time and cost.
Why Axonator?
- Axonator is a no-code mobile app builder platform.
- World’s first mobile-focused & Highly customizable no-code architecture to support real-world scenarios.
- Deploy enterprise-grade solutions rapidly as per unique requirements
- Generate reports automatically and automated data collection for trends and analytics
- Streamline processes and implement a fully automated system within weeks using Axonator’s MicroApp strategy.
Available on Android, iOS, and the web, Axonator is a highly customizable no-code field workflow automation platform mainly used to transform your paper and spreadsheet-based manual processes and maintain ISO 13485 Certification Plan in numerous industries.
Axonator offers several simple and ready-to-use enterprise-grade apps for field workflows like inspections, audits, safety, asset management, and work orders that can be used by organizations to replace paper, spreadsheet & cumbersome desktop-based manual processes with mobile & tablet apps.
