These days, managing quality assurance and regulatory compliance is crucial.
As global interaction increases, so do new laws and regulations. Increasing laws and regulations call for increased regulatory compliance and quality management through effective standard operating procedures (SOPs).
Regulatory compliance requires companies to comply with industry, state, and federal laws, policies, and regulations. More and more, companies are using digital Standard Operating procedures to better manage regulatory compliance and keep team members in the loop.
Standard operating procedures with regulatory checklists lay out the technical and quality requirements that meet compliance. Online, easy-to-follow standard operating procedures increase regulatory compliance by:
Companies can reduce risk by updating online standard operating procedures when new situations pop up and efficiently distribute the SOPs to workers and team members.
For quality planning and quality assurance (QA), standard operating procedures should include testing or evaluation features that establish an employee’s level of comprehension on any assigned SOPs.
Online SOPs will give managers immediate access to this information and promote quick response to any knowledge gaps or process deviation. This at-your-fingertips documentation will show regulators that a company is committed to effective employee education rather than simply documenting the distribution of the SOPs.
Completed SOP, with regulations included, will indicate compliance with industry regulations and governmental requirements. In fact, during auditing procedures, inspectors frequently rely on completed SOPs as checklists. Good SOPs improve a company’s credibility and legal defenses.
The International Organization for Standardization (ISO) provides ISO 9000 and ISO 9001 standards for how companies should manage quality assurance and regulatory compliance. For example, ISO 9001:2015 “specifies requirements for a quality management system when an organization . . . needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements . . .”
Like ISO, specialized organizations develop standards and regulation codes to ensure quality and compliance of the products to safety, security, or design standards.
Managing regulatory compliance checklists is challenging.
If you have a large business with multiple sites managing regulatory compliance checklists can be challenging. Traditional hardcopy forms and checklists make this really hard.
But, data retention is part of regulatory compliance. OSHA, in fact, requires businesses to submit reports digitally.
CMMS help manage SOP compliance data efficiently and effectively. To check on regulatory compliance, managers can access digital checklists, pull up dashboards, and generate reports in seconds! Real-time insights make teams more agile, productive, and accountable. Managers can make continuous improvement requirements in areas that are not compliant.
Industry and regulatory noncompliance can cause real trouble these days. New global standards have become an increasingly major concern in recent years. These global standards regulate the new global nature of manufacturing.
Regulatory compliance violations can result in legal action, fines, and product removal.
The U.S. Food and Drug Administration (FDA) promotes Good Manufacturing Practices (GMPs) for food processing and requires that companies distribute new or revised standard operating procedures promptly and that each employee validates the receipt and understanding of SOP.
Siemens calls this a “management imperative.” The company website says that “If management fails to create an environment that ensures manufacturing compliance—or lacks documentation to prove all necessary steps have been taken to achieve it—it can be held accountable for compliance breaches.”
For companies dealing with asbestos removal, for example, the Environmental Protection Agency (EPA) developed NESHAP regulations. These regulations “specify work practices for asbestos to be followed during demolitions and renovations of all structures, installations, and buildings (excluding residential buildings that have four or fewer dwelling units).”
Here, in a MaintainX work order, the manager included an asbestos regulatory compliance checklist. The Dashboard will display if the checklist was completed on all asbestos-related work orders.
Remember, writing an SOP that includes a checklist of these specific regulations will provide any site inspectors with what they need to certify team members met the requirements.
What better way to do this than to create an online library of standard operating procedures, with forms and checklists for workers to sign off on when received, finished, and/or in need of urgent attention.
For any company, large or small, with multiple sites and facilities or just one, going digital with SOP and checklists provides on-site monitoring and management. Data will automatically be stored in audit-ready formats, easily available for regulators during an inspection.
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