A supplier audit is performed by businesses to ensure that the external supplier meets the organization’s quality standards. In a supplier audit, the auditor inspects if the supplier is adhering to the industry regulation practices, such as health and safety measures and correct manufacturing processes. There are various types of supplier audit to ensure quality assurance is consistent. The most common types of supplier audits are system audits, compliance audits, process audits, and product audits. A supplier audit helps ensure the suppliers follow the quality standards and maintain quality control.

In the modern world, the life sciences sector is going through a period of unprecedented regulatory change affecting organizations involved in pharmaceuticals, medical devices, and in-vitro diagnostics. The European Medical Device Regulation (EU MDR), a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensures high standards of quality and safety being produced in or supplied into Europe. By improving the safety and performance of medical devices, the EU MDR regulations are intended to improve the safety of healthcare and the performance of medical devices in Europe. To do this, the EU MDR regulations aim to create a new and improved landscape for the quality and safety of medical devices with the following new guidelines:An independent assessment of all medical devices for safety and performance before they can be marketed in the EUMore transparent information on the benefits for patients, residual risks, and a comprehensive assessment of the overall risk/benefit ratio Clear rules to enable standardization and support simpler and less complex trading between EU member states; those that do not comply will be penalizedNew rules to support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sectorPlace further responsibilities on “Notified Bodies”, an independent third party that performs conformity assessments for medium and high-risk devices

A risk management structure measures the uncertainties and predicts their impact on a business. As a result, it’s a choice between accepting risks or denying them. Acceptance or denial of risks is dependent on the tolerance levels that a business has already determined for itself. If a business puts risk management in place as a disciplined and continuous process with the intent of identifying and addressing risks, then the risk management structures can be used to support other mitigation systems including planning, organization, cost control, and budgeting. Understanding the hazards and suggesting solutions to them can provide internal auditors with a solid basis for helping to improve risk management in their organization.

Best Practice Quality Management to maintain the desired level of product or service excellence. Top 10 best practices for implementing a quality system in companies. Some of the best practices for implementing quality management in an organization are listed below. Document quality measures and metricsInvolve stakeholders to identify and define quality standardsGet feedback on quality metrics and proposed measures from within the organization, customers, and other stakeholdersImplement a proactive approach for addressing quality issues instead of a reactive approachConduct continuous quality management process throughout the lifecycleTrack quality metrics and measures to understand the trend, improve or modify quality standards, and remain compliantPeriodically review quality standards and metricsEstablish thresholds that can be used to define CAPAAnalyze quality impact across the industry, including product, finance, customer service, and suppliers managementConstantly look to improve quality

When it does not and falls outside the specified limits, it is said to be OOS or out of specification. Therefore, any incident of OOS result occurrence must be investigated and the root cause addressed. Typically, the specified limits are detailed in documents such as the compendia, drug master file, or drug application. On observing an OOS result, a laboratory preliminary investigation (Phase-I) is recommended to identify the assignable cause. These decisions are communicated by the QC team to the designated personnel on OOS being reported, who will be responsible for classifying the OOS as the assignable or non-assignable cause.

In business parlance, right from mechanical assets to heavy off-road vehicles and computer systems can be categorized as equipment. Equipment maintenance is a process that ensures the reliability of the asset through routine upkeep and corrective repair work. Industries including steel mills, food processing, construction, plastics manufacturing and automobile manufacturing must focus on equipment maintenance. One of the primary objectives of equipment maintenance is to prevent the breakdown of machinery and equipment and can be of the following categories:Preventive maintenancePredictive maintenanceCorrective maintenanceRoutine maintenanceEmergency maintenanceAside from the mandated requirement for equipment maintenance, organizations will also witness other functional benefits from performing regular equipment maintenance. Some of them areExtend the lifespan of the equipmentMinimize interruptions by preventing unscheduled downtimeReduce repair expenditureEnhance energy consumption and operational costPrevent accidents, injuries, and fatalities due to faulty equipmentImprove warranty coverageTo perform equipment maintenance, follow these simple stepsClearly define processes to analyze system performance dataMonitor operations to become aware of potential issuesProvide technicians and operators with proper training to identify and resolve issuesCreate accountability within the organization by assigning responsibilityConduct periodic inspections based on a strict equipment maintenance schedule

The major intent of a CAPA system is to focus on the root causes of particular problems and risks so that there won’t be a need for either corrective action or preventive action in the future. A general Corrective and Preventive Action (CAPA) process follows the Plan-Do-Check-Act (PDCA) cycle to resolve unexpected events. In case of systemic issues, Corrective Action is needed to eliminate a problem and prevent its recurrence while for non systemic issues, Preventive Action is required to reduce the risks of this adverse event occurring. You can use numerous techniques to improve your Corrective Action, Preventive Action approach. Failure Mode and Effects Analysis (FMEA) is another effective element of a proactive approach, that provides input for your CAPA activities.

A cloud-based EQMS can help organizations streamline and systematize quality practices. The implementation of enterprise quality management software can help with the integration of quality with enterprise-wide processes. By creating a ‘system of record’, EQMS can store everything that gets reported, and, consequently, the ‘process’ can be implemented on the shop floor. With features such as automated workflows and electronic signatures, cloud-based EQMS can help improve operational efficiencies across the organization. This paradigm shift can be attributed to several reasons:Increased customer awarenessGlobalization of supply chainsDemand for qualitySafe productsA culture of quality helps change the mindset of the employees from a reactive to a proactive approach to ensuring quality every step of the way.

To avoid such issues, businesses must focus on creating a robust supplier risk management strategy that acts as a framework or guideline that businesses will follow while Onboarding Suppliers and continuing the relationship in the long run. It is a vital part of an organization’s overall Risk Management strategy as it helps protect against disruptions in supply chain operations, prevent quality issues, and avoid financial losses. Financial risk refers to any financial difficulties the supplier might face during payment, which can jeopardize your company’s operations. To build a robust vendor risk management strategy, businesses must focus on three main areas – risk documentation, risk framework, and risk monitoring. Ongoing Monitoring to continuously track risk indicators helps identify supply chain vulnerabilities and take action when needed.

OSHA guidelines have evolved over the years to meet the changing dynamics of the work environment. By adhering to the recommended OSHA practice s, employers and business owners understand the need for these safety guidelines as it helps:Create a safe work environment that prevents injuries, illness, or even death in the workplaceOvercome financial suffering and hardship that has an impact on the workers, family, or even the employersImprove morale at the workplaceHelp build a favorable brand image among customers and suppliersLower employee attrition rateOSHA upholds the safety of the workforce through the following methods:InspectionsSevere Violator Enforcement ProgramWhistleblower ProgramHowever, OSHA has only 2,000 inspectors to monitor the 8 million employers and 130 million workers under its jurisdiction. Therefore, it conducts inspections only under the following circumstances:Imminent danger situationsFatalities and catastrophesComplaints registered by employeesReferrals from other agenciesFollow-up inspections for worksites previously found to be in violation of OSHA health and safety standardsPlanned or programmed investigations of targeted industries or areasThis makes OSHA inspection assume extra significance. But it need not be. By creating an OSHA inspection checklist and diligently adhering to it, you can minimize the chances of an OSHA inspection.

The software supports each aspect of your own change management process from initiation and review/approval through to execution tracking, verification and closure. The backbone of any quality system, CQ Change Management connects automatically with other QMS processes including CAPA, Document Management and Training Management to ensure seamless integration between QMS processes. With changes generated anywhere in your company, you need an organized method to evaluate, share, track and implement all changes properly. The system routes planned changes to impacted area heads who can review/approve changes from their own devices. As a cloud-based system, all stakeholders can work together from anywhere with any device.

The objective of a Change Control System is to help employees understand, embrace, commit, and accept changes in their current business environment. A holistic approach to ensure that the changes are implemented thoroughly and smoothly is critical to help ensure a beneficial transition while minimizing disruption. As change gets implemented, it is important to ensure that quality and safety requirements are not compromised. A change control software automates and streamlines the process of managing change while ensuring safety and quality compliance needs. ComplianceQuest’s change control software is a configurable solution that can help manufacturers create and maintain procedures to detect, document, verify, validate, review, and approve design changes before their implementation.

Implementing QMS ISO 9001 helps improve overall efficiency and productivity while boosting employee morale. A part of the ISO 9000 family of standards, ISO 9001 defines requirements for a Quality Management System (QMS). Getting certified in ISO 9001 involves preparing an organization for certification, performing an internal audit, and, lastly, performing an external audit. This external auditor will be an accredited certifier or registrar who audits the QMS against ISO 9001 specified requirements. Organizations use the ISO 9001 standard to demonstrate their ability to consistently provide products and services that meet customer and all regulatory requirements.

With CQ Document Management solution, you can manage the entire document lifecycle, gain complete visibility and rely on a single source of truth across all locations for more effective decision making. With an electronic approach to document management across the enterprise, you’ll have a central repository to create, modify, review, approve, store, organize, access and share documents globally in a controlled manner. With a workflow-driven process aided by secure digital capabilities, simplify creating and updating documents, always ensuring the right templates are used. Streamline the entire document review/approval process easily, on a consistent and timely basis. Even collaborate across your supply chain by including suppliers and contract manufacturers to get their input and keep them in the loop.

Every organization needs a robust complaint handling system to improve the complaint management process. Improving the complaint handling process continuously based on performance review. No matter what product or service your company provides, you are likely to receive customer complaints. Being unable to manage those customer complaints could damage your business reputation, customer relationships, and compliance. Since customer satisfaction is critical for running a successful business, a robust complaint handling system is a must.

All companies have a responsibility to their employees and their customers. While businesses must create a safe work environment for their employees, they must also meet quality standards in their products or service and noncompliance can damage the reputation of an organization. To protect employees and customers, industries including manufacturing, medical devices, life sciences, construction, and oil and gas have regulatory bodies that emphasize on compliance training. By training employees and maintaining a record of it, employers can ensure proper governance and meet stakeholders requirements. For instance, if an employee working at a construction site was injured on the job while working on the shop floor, compliance training, mandated by OSHA, records serves as proof that the employer had ensured all measures were taken to train the employee and maintain a safe working environment by offering a training program for various safety practices.