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Shalini's Blog – May 2021 Archive (130)

CQ Environmental Compliance

Environmental Compliance covers a broad range of laws, regulations and standards framed by governments and other regulatory bodies to protect the environment even when businesses continue to manufacture and reach out to several markets. This is to enable organizations to think about the impact they’re leaving on the environment. It reduces pollution, protects wildlife and improves the green cover so that…

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Added by Shalini on May 7, 2021 at 7:43am — No Comments

Environmental management system(EMS)

ComplianceQuest enables automating Environment Management through a Environmental management system(EMS) that offers a range of tools to help reduce the effort in tracking, managing, and reporting. It provides data for informed decision-making to achieve corporate goals as well as comply with environmental regulatory standards. The reports generated will also aid in better planning of your…

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Added by Shalini on May 7, 2021 at 6:14am — No Comments

CQ EHS Management System

Using EHS Management System, safety leaders can improve safety parameters and nurture a culture of safety among employees by:

1. Communicating the need for safety by incentivizing safe behavior, establish consistent messaging, and create accountability 2.Supporting safety measures with training to reinforce safe behavior 3. Enabling transparency in incident lifecycle management to…

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Added by Shalini on May 7, 2021 at 5:15am — No Comments

OSHA 300 and OSHA 300A

OSHA 300 refers to an incident summary form that outlines occupational injuries and illnesses including identifying information about the injured employee, a detailed description of the incident and classification of the injury. OSHA Form 300 must be updated by the employer and should complete annually, even if there are no occupational incidents occurred.

OSHA Form 300A is an…

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Added by Shalini on May 7, 2021 at 3:07am — No Comments

OSHA Compliance and OSHA Requirements

OSHA inspectors are called compliance safety and health officers and are experienced, well-trained industrial hygienists and safety professionals. Their role is to assure compliance with OSHA requirements and help employers and workers reduce on-the-job hazards and prevent injuries, illnesses, and deaths in the workplace. Inspections are initiated without advance notice, conducted using…

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Added by Shalini on May 7, 2021 at 2:10am — No Comments

OSHA Safety - Occupational Health and Safety (OHS) Administration

To ensure your organization has an ingrained culture of health and safety and follows the occupational health and safety administration requirements mandated, OSHA recommends the following practices:

1Make safety and health a priority while communicating with employees. Explain the OSHA safety practices implemented, and proactively fix any hazards that could…

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Added by Shalini on May 7, 2021 at 12:13am — No Comments

OSHA Workplace Safety Standards & Regulations

OSHA inspectors, called compliance safety and health officers, conduct on-site inspections and phone/fax investigations to ensure companies comply with OSHA safety standards requirements and OSHA workplace safety. Inspections are scheduled based on the following:

Imminent danger

Catastrophes – fatalities or hospitalizations

Worker complaints and…

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Added by Shalini on May 6, 2021 at 9:01am — No Comments

Health and Safety Incident Management Software

Centralize all your incident data, near misses, safety observations, investigations for implementing agile corrective actions with ComplianceQuest’s Health and Safety Incident Management Software.

Furthermore, mitigate risks and prevent accidents by detecting a hazardous trend ahead of time using built-in analytics, predictive intelligence, dashboards, and mobile capabilities. By instilling an…

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Added by Shalini on May 6, 2021 at 6:46am — No Comments

CQ CAPA (Corrective And Preventive Action) Management Software

With CQ CAPA Management Software, you can identify and initiate a corrective and/or preventive action process, detect trends, conduct or link to an existing investigation and root cause analysis (RCA), define action plans to change or improve, and ensure effectiveness checks with a structured verification and closure.

For any enterprise, a robust CAPA process is crucial to address systemic issues…

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Added by Shalini on May 6, 2021 at 6:21am — No Comments

A Model for Customer Complaint Management System

Customer complaints refer to when a business does not deliver on its commitment and does not meet customer expectations in terms of the product or services. The vital aspect of every business is its clients. For greater success, businesses need more satisfied clients. And the best way to obtain new clients and maintain the existing ones is by providing them with satisfactory service. But how to understand whether your customers are happy or unhappy? A…

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Added by Shalini on May 6, 2021 at 5:07am — No Comments

Lifecycle of Incident Management

Incident management is a set of procedures and actions taken to rectify crucial incidents and respond. It could include steps such as identification and communication of incidents, tools used, assigning responsibilities, and setting down steps or actions taken to solve the incident. Incident management processes are used across functions in an organization to centralize all incident data, near misses,…

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Added by Shalini on May 6, 2021 at 3:07am — No Comments

European Union Medical Device Regulation (EU MDR) Overview

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…

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Added by Shalini on May 6, 2021 at 2:24am — No Comments

ComplianceQuest's Sustainability Management

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…

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Added by Shalini on May 6, 2021 at 12:15am — No Comments

Introduction to Risk Mitigation

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…

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Added by Shalini on May 5, 2021 at 9:00am — No Comments

Change Control Management Plan

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…

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Added by Shalini on May 5, 2021 at 6:37am — No Comments

Introduction to Equipment Maintenance

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.

Added by Shalini on May 5, 2021 at 5:38am — No Comments

What is Equipment inspection?

A formal equipment inspection program is required to ensure that operators know what to inspect on any specific type of equipment. The program should incorporate comprehensive guidelines and checklists for each piece of equipment and make it available to operators. The guidelines should set up requirements for periodic inspections by mechanics and daily inspections by operators. Inspection documents can make…

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Added by Shalini on May 5, 2021 at 2:58am — No Comments

Why is cGMP Compliance Important?

cGMP compliance assures consumers that the drugs are manufactured following the stipulated quality practices. As cGMP emphasizes quality control, the facilities are built as per a regulated design and manufacturing process. The FDA emphasizes the need for cGMP compliance to ensure the drugs that reach the market are safe for consumption. Notably, the recent cGMP regulations were published in 2016. cGMP compliance…

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Added by Shalini on May 5, 2021 at 2:21am — No Comments

FDA Adverse Event Reporting System (FAERS)

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event…

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Added by Shalini on May 5, 2021 at 12:56am — No Comments

Benefits of IATF 16949 Certification

Being IATF 16949 compliant is not a regulatory requirement but can also benefit the businesses by improving processes and efficiency that drives cost savings. Besides ensuring customer satisfaction and improvement, some of the other advantages to get IATF 16949 certification include—

Reduced operating costs

Improved stakeholder relationships

Proven business…

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Added by Shalini on May 5, 2021 at 12:11am — No Comments

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