The ten objectives of CAPA FDA implementation are:

Validate that the CAPA system procedures that deal with the quality system requirements regulation have been specified and documented.

Define if appropriate sources of product and quality problems have been identified and make sure the data sources are analyzed to identify existing product and quality problems that may require corrective action.…

FDA training is necessary to remain compliant. It makes employees keep abreast of the current regulations and guidance and how to adhere to them. The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.

ISO 45001 certification is an International Standard for Occupational Health and Safety Management Systems that provides a practical solution for organizations to improve the safety and health of employees and other personnel proactively and prevent injury and ill-health. ISO 45001 is applicable to any organization regardless of its size, nature, and type

ISO training allows organizations to streamline and optimize their in-house training processes. It promotes any organization to:

1. Identify the proper training needs 2. Effectively train employees on ongoing processes 3. Track and manage employees training growth

Quality managers use ISO 13485:2016 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements. The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit. The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard…

An ISO 14001 checklist is used during EMS audit to check for compliance with ISO 14001:2015. This ISO 14001 checklist ensures that the current EMS meets all the required ISO standards. An ISO 14001 checklist is important as it —

1. Helps meet compliance requirements of the ISO 14001 standard 2. Records the steps of the EMS implementation process 3. Acts as a supporting document for…

ISO 14001 certification is a reliable, effective, and responsible environmental management system for business operations. The amount of human labor, time, and resources to create and implement a total EMS solution is excessively onerous for many businesses. Therefore, to provide the infrastructure to achieve ISO 14001, most EHS experts are trying to meet ISO 14001 standards relying on an…

Health and safety management systems are a key factor if you want a workplace that’s healthier and safer. Developing a health and safety program in your workplace is an efficient way of protecting your valuable asset, that is, your workers. The organization should maintain and establish procedures to respond to accidents and emergency situations and to prevent and reduce the health and safety impacts associated with them. They should provide the framework and structure to create…

HSEQ stands for Health, Safety, Environment and Quality. An HSEQ Management System is a tool aimed at quality, occupational health and safety, and the environment to prevent or mitigate both human and economic losses arising from accidents, adverse occupational exposures, and environmental events. The goal of the HSE Management System is to ensure that the organisation complies with…

Safety investigation is conducted to prevent accidents in a work environment. Safety managers must conduct an effective safety investigation periodically to ensure the safety standards are met to avoid penalties and prevent accidents.

Here are the steps that safety managers must follow while conducting a safety investigation –

1. Gather relevant information about the safety standards in…

Behavioral observation is the systematic recording of behavior by an external observer. The systematic nature of behavioral observation is characterized by detailed procedures designed to collect reliable and valid data on client behavior and the factors that control it. Behavioral observations are an opportunity to deliver both positive and constructive feedback. It is a feedback session structured around…

Hazard analysis is a continuous process that has to be performed to mitigate hazards that can be introduced at any stage from requirements, design, development, product testing, installation, commissioning, operation, system maintenance, and disposal of a system. Some of the events that could initiate hazard analysis include –

Concept definition

Reviews of requirement, design, design…

Job safety analysis (JSA) is a procedure that helps integrate accepted safety and health practices into a particular task or job operation. In JSA, the ultimate goal is to identify potential hazards in every step of a process and recommend the safest way to execute the job. JSA is a written procedure developed to understand, review, minimize or eliminate hazards associated with work processes. A job safety…

CQ’s Health and Safety Management Solution enables companies to centralize all incident data, near misses, safety observations, perform an investigation, and implement corrective actions. Various features part of the CQ health and safety management software include –

1. OSHA reporting and compliance 2. Near miss 3. Injury and illness 4. Property, assets, and motor vehicles 5.…

Work health and safety (H&S) refers to the risks of injury and illnesses in the workplace impacting employees, visitors, customers, and suppliers. Businesses need to do a risk assessment to identify the hazards and risks in their workplace and put in place control measures to prevent their occurrence or reoccurrence, as the case may be.

Health and safety systems are an essential part of…

ComplianceQuest offers a Workplace Safety App for Work.com to help employers manage their employee health and safety information effectively and efficiently. This app can help protect workers, reduce safety costs, and lower risk to operations by facilitating safety and HR leaders to collaborate effectively to design safety processes and continuously improve workplace safety standards. The app includes…

In any organization, both safety and quality are equally important and go hand-in-hand. Although a business can opt to produce a quality product without establishing robust safety management, the price to pay is high in case of a disaster. An unfortunate accident often acts as the catalyst to move from silos to a more integrated system for quality and safety management. As a result, enterprises are now focused…

Quality assurance is defined by ISO 9000 as a “part of quality management focused on providing confidence that quality requirements will be fulfilled.” With QA, manufacturers can ensure that customers receive a defect-free product by preventing mistakes at the time of manufacturing. Businesses can improve compliance to standards by monitoring processes and use feedback to improve efficiency and…

The success of a quality management training involves not only process improvement but also the involvement of employees, suppliers, and customers. To achieve the goal of producing high-quality products and services, businesses need the buy-in right from the top management to the latest intern in the organization. Customer satisfaction and retention are important for business growth, and this makes the…

ComplianceQuest’s quality solutions can impact your company by lowering the unit cost, taking essential corrective actions, achieving better utilization of raw materials, human resource, and finances to maintain product quality, achieve customer satisfaction by reducing client complaints, identify the process defects to control and minimize the scrap and waste.