The OSHA 300 is a single physical location where employers record and maintain information about employees’ injuries and illnesses. According to OSHA, OSHA Form 300 is the place where the business is operating, or where services or industrial operations are conducted or the place where employees report for work, operate from or from which they are paid. The OSHA Form 300 is divided into…

The OSHA 300 is a single physical location where employers record and maintain information about employees’ injuries and illnesses. According to OSHA, OSHA Form 300 is the place where the business is operating, or where services or industrial operations are conducted or the place where employees report for work, operate from or from which they are paid. The OSHA Form 300 is divided into…

Worker participation is an essential component of OSHA compliance, requiring workers’ involvement and participation in establishing, operating, evaluating, and improving workplace safety and health programs. To have an effective safety and health program, all workers:

Are encouraged to provide inputs and report safety or health concerns without any fear

Need access to…

Worker participation is an essential component of OSHA compliance, requiring workers’ involvement and participation in establishing, operating, evaluating, and improving workplace safety and health programs. To have an effective safety and health program, all workers:

Are encouraged to provide inputs and report safety or health concerns without any fear

Need access to…

OSHA upholds the safety of the workforce through the following methods:

Inspections

Severe Violator Enforcement Program

Whistleblower Program

However, 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 situations

Fatalities and catastrophes

Complaints registered by employees

Referrals from other…

It is essential to have a OSHA safety checklist that will cover all aspects of the compliance requirements. The four broad components of the implementation process include:
Operational elements such as risk assessment, emergency responses, process verification among others
Training
Communication
Documentation

As workplace complexity and health & safety risks have increased over the years, the OSHA safety standards guidelines too have evolved. By adhering to the recommended OSHA safety standards and practices, employers and business owners can:

overcome financial suffering and hardship that can affect workers, family, or even the employers

prevent illness, injuries,…

Socially responsible organizations manage their impact on the environment, promote social responsibility, and comply with government regulations on emissions, renewable resources, and recycling. To do this consistently across all locations in a harmonized manner is not an easy task. Keeping up with the environmental regulations that is constantly changing makes reaching the sustainability goals even harder. CQ’s…

Risk management structures are adapted to do more than just indicate existing potential risks. 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.

Risk mitigation is a systematic process where an organization develops actions and options to increase opportunities and reduce threats to project objectives. Risk mitigation implementation refers to the process of risk mitigation actions. Risk mitigation progress monitoring tracks identified, new and existing risks, and evaluates the risk process effectiveness throughout the project.

By taking…

Change control management system refers to the controlled set of actions to ensure that a change does not negatively impact a product’s safety, quality or compliance. The control may be proactive or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.

The important features of change control include:

A plan that identifies…

Worksite inspections are a chance to evaluate risk and detect hazards in the worksite as inspections reveal display the current state of the worksite and any activities. An organization can take the appropriate controls. Worksite inspection can help an organization prevent unsafe working conditions from developing and identify the risk of hazards.

A formal equipment inspection program is required to…

Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA that assure systems have the proper design, monitoring, and control of manufacturing processes and facilities. FDA assessors and investigators determine if a firm has the necessary equipment, facilities, and ability to manufacture the drug to sell in the market. By adhering to the CGMP compliance regulations, a manufacturer assures the…

Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.

If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take…

IATF 16949:2016, which replaced ISO/TS 16949:2009, is an independent standard for Quality Management System (QMS) applicable to the automotive sector. Aligned to the requirements of ISO 9001:2015, it focuses on continual improvements, particularly defect prevention, reduction of waste and preventing variation in the supply chain.

To get certified, organizations need to implement a QMS aligned to…

The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is…

Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design control make a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and…

A compliance audit is a formal review of an organization’s procedures and operations mainly focusing on whether an entity is complying with internal rules, regulations, policies, decisions, and procedures. An audit report will cover the resilience of compliance preparations, security policies, risk management processes, and user access controls observed during the audit.

Compliance training is employee training authorized by regulation, legislation or policy that helps to reduce risk, maintain your reputation and improve the workplace environment to improve worker productivity in the long run. It educates your employees on the laws or regulations that are predominantly used to maintain the safety of the workplace and the dignity of the employee applicable to their job function…

FDA compliance has been designed to ensure that companies enforce QMS processes that will create higher quality products. In today’s competitive world, it is difficult for businesses to meet stringent FDA regulations as they are seeking to balance both quality control and ROI. ComplianceQuest is the leading provider of FDA GxP QMS solutions that improve your organization’s quality…