Compliance management for any organization or business can be defined as the methodology that is designed to protect and enhance business value by adopting a regulatory risk-aware culture. Even today many companies assume that ensuring compliance requirements are met is as simple as performing a scheduled audit. This prospection is absolutely wrong, as compliance management addresses ongoing compliance requirements with the ability to improve business development.
Earlier this Compliance management was Reactive, where the benefits can be seen only when a process or any action is performed. Even the name tells that the achievements and benefits are measured only after the reactions, but this method will not be useful and fails in many cases while adopting a regulatory risk-aware culture.
To replace this existing Reactive compliance management, Predictive compliance management has been incorporated in Quality Management Process, Predictive Compliance will help businesses to identify, investigate, and communicate compliance within the organization resulting in a more effective and efficient Quality Management System.
Advantages of Predictive Compliance
- Helps to proactively evaluate and manage potential compliance issues before they are assessed.
- Allows to dramatically reduce costs of compliance and assists in allocating resources for safer, more efficient operations.
- Provides unique and effective approach to Automate compliance management
- Helps in predictive decision making, impacts compliance costs, resources and operations
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For every process gap in an organization, corrective action to be taken with appropriate Root Cause Analysis (RCA), effective Root Cause Analysis will have the capability to “kill” the problem forever. Every business should know the importance and necessity of RCA and also the analysis can be performed in both ways either reactively and proactively. The reactive mode of performing Root cause analysis failure is RCFA and the proactive analysis is by doing risk analysis and opportunity analysis. if the derived RCA is effective, the findings of an RCA can be applied proactively to similar situations, thus preventing failures from occurring elsewhere.
If RCA is effectively done, then the organization can gain below benefits
Solving Real-time Problems
Once if it is effectively done then all real- time problems in the same scenario can be solved using the Root Cause Analysis and Why Why Analysis
Less Spend
Single Analysis is applicable to all scenarios; thus it saves more time in analyzing root cause for every single problem
Longer Lasting Solutions
RCA for each solution option is evaluated against criteria the focused on preventing recurrence of the problem, rather than short term fixes.
Effective Root Cause Analysis brings much more impact on business process outcomes. Thus adapting the right Quality system will be much more helpful in improving quality standards and fixing process gaps. For more detail visit www.auraqualitymanagement.com or leave us an enquiry
In today’s digital age businesses are moving faster than ever and also the number of companies and industries budding every day. These new and small level companies offer consumers new and exciting options that have never been available before. At the same time, these offers sometimes might become a headache for government regulations, since these regulations can’t seem to keep up with the speed of technology changes. For every industry nevertheless of size meeting up with regulatory compliance is significant.
Now, compliance outcomes are under greater scrutiny than ever with general public and consumers expecting high levels of compliance across all industries. There are plenty of mitigation steps that an organization can take to avoid problem and make sure that their organization doesn’t end up in the same situation. Below are the few things an organization should look for to achieve Quality benefits:
Auditing System: The auditing system that a business has should handle both internal audits and external audits. This includes initial setup for questions to audit report publishing, which should be understandable without the need for extensive explanations or clarifications. This process helps in analysing gaps within the organization.
Risk Assessment: To make auditing process efficient it is significant to cover everything that a business needs to be covered, the QMS software you use should be upto the range and effectively track audit findings and analyse the risks before that affects the business process. Risk assessment and mitigation planning is the crucial update in ISO 9001:2015, proper risk analysis helps in maintaining compliance.
Corrective Actions – When a non-conformity is identified and corrective action is required for that, then the corrective action taken should be clear and understandable. After corrective action is taken Root cause analysis and why why analysis should be done to get clarity and reporting and the auditor should see evidence of the correction and close or resolve the issue. This saves time, money, and ultimately any escalation of the issue that might cause even more problems.
For more details and queries about QMS, keep visiting our website www.auraqualitymanagement.com or leave us an enquiry. Aura will be your Quality guide.
Risk always has an implicit impact in ISO standards, but now the recent updates and newer standards are giving risk a role in quality standards. Updated standards like ISO 9001:2015 and 14001:2015 require organizations to employ and include risk-based thinking in every business process across the organization. This greatly help organizations to analyze the risks before that occur.
So, what exactly does ISO mean by risk-based thinking? This is a procedure of understanding and analyzing deeper into a routine scenario that takes place in an organization. Also this serves as a preventive action platform for businesses. Risk assessment drive changes and enable businesses to build alerts for critical events and include guidelines, solutions for risk levels that are unacceptable. These risk assessments are systematic, repeatable and can be implemented for high risks in a consistent manner.
Risk-Based assessment follows the below steps:
- Risk identification
- Risk analysis
- Risk evaluation
- Risk Control
- Risk Communication
- Risk Review
These analysis serves as a bridge to identify and fill the gaps in business process and helps to take necessary corrective and preventive actions ahead to rectify and resolve issues before that occurs evaluating those identified risks will help businesses to take care of those gaps and act upon it immediately. It’s also important to note that risk isn’t limited to negative possibilities. Companies can also use risk-based thinking to pinpoint opportunities, which represents the positive side of risk.
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Every business today endeavors to increase market share, cut down costs, improve customer satisfaction, manage risk and to benefit business bottom line. The best way to accomplish these goals is to be certified for quality through international standards. Quality is becoming a recent company-wide initiative, there is a need for quality solutions to help gain visibility and control. Automated QMS not only controls quality management processes, but also provides visibility for a top-down view on the entire Quality Management System.
Businesses might develop many effective strategies to resolve the issue seamlessly. Having an automated quality management system enables you monitor the defined process by giving better visibility and by enabling you to make timely identification and response to issues. Automated quality management system helps businesses to take corrective and preventive actions, analyses & identify the root cause for non-conformities and helps fix it right way.
Change is inevitable, even in driving non-conformances or corrective actions, or a need to try new operations or strategies. Utilizing an automated QMS helps to track the progress and effects of the changes as you go. This means that the whole quality management process is automated and simplified.
- Risk-based decision making
QMS enable businesses to analyze risk from diverse perspectives, giving better visibility and ensuring that you don’t lose sight of the most critical items. Risk management is becoming the heart of any business decision, this improved visibility into risk gives the ability to identify most suitable options.
Automated quality management solutions will be an excellent solution for greater productivity, efficiency and customer satisfaction. Get your QMS Automated Now and streamline business processes.To know more in detail visit www.auraqualitymanagement.com or leave us an enquiry.
Implementing a risk-management program may seem like an excessive work for small businesses, but to consider such a plan has significant role in business operations planning. Risk-management and analysis programs gives both strategic basis and the operational framework for handling crisis within an organization.
Risk management principles can be effectively utilized in many areas of businesses such as occupational safety, operations, finance, public health etc., Risk in general is the combination of the probability of occurrence of harm and the severity of that harm. ISO now has addressed the notion of global risk management approach to businesses in its standards, which gives an organizational-level risk management approach.
Risk assessment, the significant way of analysing and evaluating risks associated with exposure to organization process. Quality risk assessments begin with a well-defined problem description or risk questions, these questions might be.,
- What might go wrong?
- What will be probability it will go wrong?
- What are the consequences?
When answers for these questions are well defined then risk in the process can be easily identified, an appropriate risk management tool will help you do it. Risk management can be done in.,
- Risk identification
- Risk analysis
- Risk evaluation
- Risk Control
- Risk Communication
- Risk Review
After the in-depth analysis below questions can be addressed, these really serves the purpose.
- Is the risk above an acceptable level?
- What can be done to reduce or eliminate risks?
- What is the appropriate balance among benefits, risks and resources?
- Are new risks introduced as a result of the identified risks being controlled?
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Auditing – the means of evaluating effectiveness of a company’s internal controls, and to achieve business objectives, maintaining an effective system is vital. Both internal and external auditing finds a significant place in organization development. Recurring analysis of a company’s operations and maintaining rigorous systems to have internal controls can prevent and detect various non-conformities and other accounting irregularities.
The current business environment has turned its spotlight towards internal audit management system that drives effective compliance and improves quality. Internal Audit helps an organization to achieve its objectives by bringing a streamlined systematic approach to evaluate and improve the effectiveness of process followed. Internal audit chiefly covers analyzing, assessing an organization’s current process, procedures and helps to take necessary corrections & corrective actions to achieve the defined objective. Effective internal audit management system can be a built-in component to the manage quality process that keeps business aligned to the mission.
Conducting Audits and obtaining ISO 9001:2015 certification can be a complex and demanding process, many businesses find this certification process challenging even during the implementation phase. Here are the top 10 clauses of ISO 9001:2015, this can be taken care and maintained well before applying for re-certification.
- Clause 0-3 – Introduction and scope of the standard
- Clause 4 – Context of the organization
- Clause 5 – Leadership
- Clause 6 – Planning
- Clause 7 – Support
- Clause 8 – Operation
- Clause 9 – Performance evaluation
- Clause 10 – Improvement
Look into the clauses, be benefited and get certified as an ISO 9001:2015 certified company. To know more details on QMS updates, visit http://www.auraqualitymanagement.com , we keep you informed.
In today’s quickly evolving digital economy, businesses and enterprises worldwide need to continuously focus on improvements and innovations to keep their business processes updated in order to meet the ever increasing demands in Quality management.
Continuous improvement the most common term often used in regards to any quality management objective drive benefits to the shareholders. Also continual improvements focus on setting goals for best practice across the board, from customer service to management processes and reporting.
ISO 9001 certification will be beneficial for both organization and customers. However, running a business in an efficient and cost effective way requires quality work from all executives too. Implementation of continuous quality improvement requires the commitment of the organization as a whole and this implies that the organization must adopt this continuous quality improvement culture.
Improving your organization’s Quality Management Systems can positively boost your profitability. Likewise, implementing ISO standards and migrating your processes from ISO 9001:2008 to 9001:2015 is also a way of continual improvement.
Migrating to ISO 9001:2015 organizations can achieve below given benefits:
- Emphasis on Leadership
- Risk Management
- Business Opportunities Identification
- Enhanced Continual Improvement plans
- Performance Measurement and Monitoring
- Easy Integration of Management Systems
- Increased Competitive Advantage
Have your best Quality management software and analyze your Quality metrics and drive continual improvements .To get the advantages of industry leading QMS leave us an enquiry or visit www.auraqualitymanagement.com
A Quality Management System (QMS) is a formalized system that documents procedures, processes and responsibilities for achieving quality objectives. Customer feedback is crucial for measuring the effectiveness of quality management system in an organization. Satisfied customers will be a valuable resource and offer many business benefits. According to ISO 9001:2008 Customer satisfaction is defined as “customer’s perception of the degree to which the customer’s requirements have been fulfilled”. Many successful organizations have figured out that customer satisfaction has a direct impact on the bottom line.
Organizations provide customers the flexibility in what indicators and rating scale they provide feedback. Following is a simple customer response scale that can be used for each performance:
- Very satisfied
- Satisfied
- Poor
- Dissatisfied
- Very dissatisfied
Depending upon the nature of business and number of customers, organizations can try out different rating scales and performance indicators to find a combination that is effective. It is also important to have honest assessments when it comes to customer satisfaction. A good QMS will help businesses to automate and streamline customer feedback. This helps a company to do no mistakes by following business process and stick to QMS standards. The ability to learn and grow is what makes customer care such an integral part of any QMS.
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The regulatory landscape continues to change in today’s business world. One of the systematic quality approaches defined by regulators and the industry for mitigating risk is corrective and preventive action, better known as CAPA. Businesses and organizations are often challenged by the CAPA process, which is one of the most important and essential elements of a quality management system. An effectively implemented and integrated CAPA program, can benefit in all areas of an organization and inadequate execution of a CAPA strategy continues to be one of the most common nonconformities cited during audits.
Common CAPA pitfalls:
- Implementing CAPA rather analysing the actual root cause
- Driving CAPA process than on deliverables
- Setting unrealistic timeframes
- Using same root cause analysis tool
- Delays in actions and decisions
A well-organized CAPA program within the quality management system (QMS) help businesses to identify, track, correct and prevent recurrence of non-conformities. Proper CAPA strategy helps businesses to resolve bugs, errors, anomalies and issues. So It is essential component in any QMS to maintain quality as well as the existing quality standards. Paper-based systems may be cost-effective but they are inefficient and require extensive man-hours for issue resolution. Automated QMS system will save more on time and helps to conclude discrepancies with actual resolution of the CAPA
Benefits of having QMS for CAPA:
- Decreased cost of quality (scrap, nonconforming products, complaints, field actions, process deviations)
- Minimal resource utilization
- Enhanced communication
- increased process efficiencies
- improved traceability
To get further more details about CAPA and Automated QMS solutions Contact us @www.auraqualitymanagement.com
