7 min read
The importance of SOPs cannot be overstated. Good standard operating procedures (SOPs) provide a way to communicate and apply consistent best practices around business processes within your organization. Businesses strive to maintain operational excellence and SOP compliance – especially in anticipation of audits.
Regulatory bodies conduct audits and inspections to ensure compliance with regulatory requirements, safety, quality, industry regulations, and environmental protection, just to name a few examples.
So, you know that you need to have SOPs. And you need to prove that people are using them. If you fail an inspection, what could happen? Do you have to pay fines? Are there legal ramifications? Government investigations? Bottom line, the consequences can be severe. The investment you make in SOP management is well worth it.
When each employee follows SOPs, compliance is enforced.
That’s why ensuring SOP compliance in your organization – and being able to prove it – is a must to pass an audit and at the same time, reduce the risk of serious errors or mishaps happening in the first place.
5 Tips for SOP Compliance in Your Organization
You’ve done your work, your SOPs are written, and documentation has been approved and published. Now, how do you ensure people are using them and staying compliant?
In our many years working with organizations, we continue to hear all too often, “Even after devoting significant resources to SOP development, our people aren’t using them. Audits continue to be painful and costly.”
Here are five proven guidelines that will improve SOP compliance and reduce compliance costs.
1. Ensure Clear and Accessible SOPs
Clear and accessible SOPs are the cornerstone of SOP compliance. Since SOPs guide team members to execute tasks accurately and consistently, SOP content needs to be complete, well-structured, easily understood, and readily available. It's also essential that SOPs are current and employees always have access to the right version.
Your focus needs to be on your audience, the users of your SOPs. Remember: SOPs only have value if people are using the SOPs consistently. Disorganized, outdated, or unused SOPs lead to citations, delays, and failed audits.
When creating effective SOPs, keep a consistent format and avoid jargon, instead using simple language. Make step-by-step instructions for a specific task easy to follow. To further increase comprehension, include visual aids such as images, videos, charts, or diagrams. Be sure to also add examples when necessary. (Check out this related article How to Write a Standard Operating Procedure)
Incorporating enforcement features like checklists and employee attestation also increases accountability and adherence (and sometimes is required for audits to prove SOP compliance).
Make sure it's easy for anyone to find relevant SOPs at the moment they need them. Organize your SOPs in a logical manner.
Clarity and accessibility benefits employees and enhances the auditors’ experience. Over the years, we’ve heard auditors and regulators alike tell us that when they walk into an organization and can easily find well-thought-out SOPs and policies, this boosts their confidence in the organization as a whole. Audits go faster, overall compliance costs are reduced, and quality assurance is increased.
TIP: Before you publish an SOP, test it. Make sure someone unfamiliar with the task uses the procedure to perform the task. Note their questions, difficulties, and any room for human error. You may need to edit the SOP two or three times to perfect it.
2. Create and Link Related Policies
When creating SOPs for compliance, don’t forget policies. Policies are your standards, your guidelines. Most regulations require both.
It's important to understand what auditors and regulators don’t like to see so that you can avoid these common mistakes:
- SOPs without related policies
- Not understanding the difference between policy and procedure (even intermixing them in documents)
- Putting policy and the related SOP sections in a single document (hardwiring policy to procedure)
Create relevant policies and link them to the relevant SOPs.
If you or your team is unclear about the difference between policy and SOP, our blog post will help.
3. Facilitate Communication and Awareness
SOP compliance success within your organization depends heavily on how you roll them out and communicate their value. You can create the best SOPs possible, but unless employees know they exist, WHY they exist, and where to find them, employees won’t use them.
Your communication and orientation program might consist of:
- A campaign utilizing internal company communication platforms
- Department leaders walking employees through key policies and SOPs
- Adding links to SOPs into your LMS or other online systems
- Scheduling ongoing attestations
- Onboarding for new employees, including an SOP overview
It's also important that as SOP updates are available, relevant employees are aware of them.
4. Organize Implementation and Enforcement
Implementation involves clearly defining roles and responsibilities and assigning accountability for SOP compliance.
You can handle SOP enforcement in a variety of ways:
- Attach quizzes or tests to important policies and SOP documentation. Retest employees on new versions.
- Require that employees verify they’ve read and understood SOPs. Use employee attestation such as an eSignature.
- Turn critical SOPs into interactive checklists.
All of the above methods will further SOP compliance and provide compliance proof to management and auditors.
5. Establish Regular Review and Revision
SOP maintenance should be an ongoing process. Regularly reviewing and updating SOPs to align with evolving regulations and best practices is vital to ensure SOP compliance within your organization.
Establishing a systematic review cycle by compliance teams, whether that be quarterly or annually, ensures that SOPs used by your employees are up to date and include all relevant information and necessary steps. This is also the time to reflect is a new SOP is necessary to add. Engage all relevant stakeholders in the review cycle, including both managers and frontline employees, to include diverse perspectives.
When revising the SOPs, document all changes and communicate these updates to any involved persons. This will increase SOP compliance by reminding employees of the SOPs, encouraging continuous improvement, and empowering them to always take the right action.
Tips for Audit Preparation
We understand that audits and inspections can be a stressful time within your organization. Pulling together the required documentation and ensuring employees are properly trained and aware of the organization’s SOPs can be a daunting task.
When you have sufficient SOP compliance within your organization, audit preparation is much easier. Below are a few audit preparation tips:
- Conduct regular internal audits to identify areas of improvement. By consistently managing regular audits, you can gain valuable insights into organizational operations and identify areas that may need improvement with risk assessment. These self-assessments can help to streamline operations, take corrective action if necessary, and mitigate risk, safeguarding the organization when external regulatory bodies conduct their own inspections.
- Organize documentation and records for easy access and review. Successfully organizing internal documents involves categorizing, indexing, and storing records in a centralized location accessible to authorized personnel. This includes not only the SOPs themselves, but also the proof that employees are using them properly.
- Train employees on audit procedures and expectations. Employees are better equipped for inspection when they are aware of what to expect, how to prepare, and their roles and responsibilities during audits. They should also be made aware of how to properly document and maintain records and compliance efforts before the audit process.
- Engage with auditors professionally and transparently. Open communication and collaboration are necessary to build trust and result in successful inspection outcomes. Proactively share relevant information and ensure documentation and employees are ready to demonstrate a commitment to compliance.
- Implement an SOP platform. Specialized SOP systems make SOP compliance easier because they contain features that automate manual tasks and help enforce compliance. As a result, your SOP and policies are well-organized and easily accessible by auditors. These systems often include tools such as attestation and analytics so that managers and auditors can prove that employees have read and acknowledged key policies and SOPs.
Why You Need a Specialized SOP Platform to Increase SOP Compliance
There are plenty of steps you can take right now to increase SOP compliance and streamline audits. Our recommendation — which will make the biggest impact — is to implement an SOP platform.
A specialized SOP platform is an end-to-end system that handles all aspects of policy and procedure (SOP) management: creation, review, translation, distribution, updating, and enforcement.
Like many organizations, you may be using MS Word, MS SharePoint, or other general-purpose tools for your SOPs. This do-it-yourself approach is manual, error-prone, and burdensome for everyone involved, including auditors. Because these tools lack built-in controls, everyone does their own thing, resulting in SOPs that are inconsistent, difficult to use, and often out of date.
When you lack the tools to develop required SOPs and policies efficiently and ensure they meet standards and requirements, audit and audit preparation may take longer than it should. Inadequate documentation could mean citations and unnecessary liability risk.
Zavanta is our SOP platform, has the essential structure and features needed to streamline the audit process, ensure SOP compliance, and make auditors and regulators happy:
- Centralized, fast access to SOPs. Zavanta gives employees access to the SOPs that they need to successfully do their job – at the moment they need them. By making SOPs accessible, employees are more likely to adhere to established protocols, increasing SOP compliance and operational efficiency.
- Guided Authoring. Even novices can create SOPs that are clear and easy to follow. Instead of a blank screen, Zavanta prompts authors for the right information, in the right order, and automatically applies a standard format. SOP creation is less ad hoc and more efficient.
- Version control. Operational documents need to be up to date. Zavanta’s built-in version control ensures employees access the most recent documents. Lack of version control will negatively impact your audit results. Check out this case study about a government contractor who failed an audit when they found an employee with a printed SOP that was outdated and did not match the online version in their MS SharePoint repository.
- Access control and permissions. Zavanta’s security and permissions ensure that only authorized individuals have access to relevant SOP documents and sensitive information. Administrators and managers can easily lock down the system to prevent unauthorized changes.
- Collaboration and communication. An SOP platform should include tools that promote collaboration and communication. Zavanta’s feedback feature enables employees to comment and suggest any policy or SOP. Management has real-time access to employee feedback, enabling them to make improvements and improve understanding. Employees are more engaged when they are part of the process, which increases SOP compliance.
- Audit trails and compliance reporting. SOP platforms like Zavanta include a clear audit trail and reporting functionalities allowing organizations to track SOPs compliance. Changes across all life cycle phases from creation through delivery and ongoing updates are recorded in the system, decreasing the risk of errors. The policy or SOP is never taken out of the audit chain.
- Link to standards and regulations. Compliance is more integrated into operations when standards and regulations are connected to your SOP system. With Zavanta, you can link external sources (such as FDA, OSHA, JACHO, CMMC) to your SOPs and policies.
- Automatic reminders and notifications. Staying on top of everything (reviews, assigning authors, and alerting employees when new versions are available) is a major challenge. Large organizations especially need “set it and forget it” automatic reminders and notifications. Zavanta’s notification system and workflows automate these tasks and ensure nothing falls through the cracks.
- Checklists. Take SOP compliance to the next level with checklists. With Zavanta, it's easy to transform any high-risk SOP into a checklist. Assigned users are required to check off steps as they perform them and eSign when they’ve completed the SOP. Managers can monitor progress. Checklist data provides auditors proof that employees aren’t just reading SOPs, but that they are actually following them.
Case Study: Covenant Pathology Services
For our client Covenant Pathology Services, having Zavanta as their SOP platform made the world of difference when it came time to complete an audit.
Prior to Zavanta, Jessi Gunter, Quality Manager, handled all SOP compliance-related information in an MS Excel spreadsheet. This method was time-consuming, prone to errors, and stressful during inspection times - a significant challenge in her role.
Audits are now a breeze with Zavanta. Jessi shares, ““Inspections can be scary -- 5 people walking around with clipboards -- when inspectors come on site. I can sit an inspector in front of Zavanta and say ‘have at it’ because the system is friendly enough for them to navigate. They can easily see you’ve got your bases covered. I felt like a ‘golden god’ after our first inspection using Zavanta. The inspection was pretty painless because I had all the answers at my fingertips. The inspectors finished in half the time planned.”
Increase SOP Compliance with Zavanta
Like Covenant Pathology Services, we’ve helped hundreds of organizations operationalize SOP compliance, streamline audit preparation, and significantly reduce compliance costs. With Zavanta, you have a system you can manage with, train from and that auditors and regulators love.
Contact our team today to learn more.
Additional Resources:
