Quality Control with Compliance Software

Quality Control with Compliance Software:
You are probably well aware that the idea of compliance software was definitely an idea worth rejoicing over. However, though the idea itself is worthy of eureka-praises, the problem with compliance software is that there are so many varied solutions it is hard to know where to start. It’s like choosing a personal chef. Just getting up one morning and hiring someone with the title “chef” will never work. You have to take the time to find who (or what) works for your unique taste buds. With compliance software, the process is similar. You have to take the time to find a flexible solution that fits the needs of your company. However, before you run off to start reading compliance software reviews let this article provide you with a simple suggestion:

Start by finding compliance software that simultaneously manages your quality control processes.

Sound impossible? It’s not.

Quality Control and Compliance Solutions:
A “One-Two” Punch to the Regulatory Gut You may not have realized it but there are http://www.mastercontrol.com/solutions/quality_management_fb.html""> quality control software solutions that allow you to manage both quality-control related processes and regulatory compliance. For instance, when you look for compliance software look for a solution that will manage your regulatory compliance requirements and quality factors such as documents (quality control and other doc types), change control procedures, CAPA procedures, customer complaints, CAPA related training, additional training, audits, and submissions to regulatory parties such as the FDA. If you don’t want to invest in all of the solutions named, find a software solution that will allow you to mix and match the featured quality control applications that you need. With this type of flexible software, the weight of the quality control and regulatory compliance burdens will thankfully (and metaphorically) be akin to feather, a butterflies or objects equally sylphlike!

Quality Control and the Internal Audit
Once you have a quality control/compliance software solution, audits will be far easier to manage. However, audits can still be exasperatingly stressful since the behavior of employees and the speed and productivity of a workflow is still somewhat dependent on the efficiency of people who are of course prone to make mistakes. So, another way to gain control and to make the audit giant cower is to simply practice internal audits on a regular basis. After all, audits are not secretly clandestine efforts that you couldn’t plan and produce yourself. An Internal audit is simply the process of repeatedly observing a system or a process, and determining whether or not that system or process meets regulatory standards and the prioritized goals of your company.

Quality Control: Put the Internal Audit into Practice
Have a clever personnel member from your company devise an internal audit process. Do research on exactly what the FDA, the ISO and SOX are looking for and beat them to the punch! That way, when it’s time for 2nd and 3rd party audits, you and your employees will breeze through the process like you were born for it.

Remember! Effective quality control and compliance software research will help your company take the next few steps towards easier compliance and more effective productivity.


About The Author, Marci Lynn Crane
Marci Crane is a copywriter for MasterControl">http://www.mastercontrol.com/index.html"">MasterControl in Salt Lake City, Utah. For more information in regards to quality">http://www.mastercontrol.com/industries/general_man.html"">quality control, or audits management software, please feel free to contact">http://www.mastercontrol.com/company/contact.html"">contact a MasterControl representative.

Critical Role for the Chief Audit Executive: Aligning Risk Assessment

When it comes to aligning risk assessment, the "risk intelligent" chief audit executive provides reassurance that management's reports are reliable, offers advice on improving risk mitigation, and implements value-added risk-management activities.

Risk permeates virtually every aspect of our personal and professional lives. Yet people and organizations are slow to acknowledge potential calamity and quick to believe that bad things always happen to the other guy.

For businesses, this flawed perception can be quite dangerous. In today's environment, which is marked by intensifying competition, increasing scrutiny, and growing threats, a frank and realistic assessment of the true risks a company faces is more important than ever.

Enter the chief audit executive (CAE). CAEs have a unique opportunity to make significant improvements in the efficiency and effectiveness of their organizations' risk-management initiatives. In previous columns, we've discussed the various roles of the Risk Intelligent CAE, such as keeping the organization's risk/reward picture in balance, incorporating risk-management activities into the internal audit function, and bridging silos to promote the sharing of information across organizational boundaries. All of which, in combination, can boost a company's risk-management capabilities.

This column addresses yet another critical role for the CAE: aligning risk assessment.

Aligning Risk Assessment

The traditional internal audit risk assessment starts with a blank sheet of paper as processes, systems, and individual entities are evaluated. In keeping with this typical approach, internal auditors audit those risks with the highest impact and probability of occurrence. Often, no distinction is made between inherent risk (the risk that exists before mitigation and controls are introduced) and residual risk (the risk that remains after mitigation and controls are implemented).

Furthermore, while vulnerability is certainly considered, too much weight is usually given to probability. Probability models work well when dealing with events that regularly occur, and for which reams of data have been compiled. But when dealing with more uncertain events—situations that have never occurred or perhaps can't even be imagined—probability should be subordinate to the notion of vulnerability.

Therefore, the risk intelligent enterprise adopts a different tack. In a risk intelligent organization, management also takes responsibility for:

• Assessing inherent risk—even those that are high impact, yet low probability.
• Evaluating the effectiveness of existing risk mitigation and controls.
• Determining residual risk.
• Deciding whether the risk exposure is within the appetite of the enterprise and further mitigating the risk, if necessary.
• Providing reasonable assurance to the board that the controls are both effective and efficient.

If the risk exposure is not within the corporate appetite, it's internal audit's responsibility to advise management on how risk mitigation and control might be improved.

Value-Added Risk-Assessment Activities

In addition, the risk intelligent CAE can lead a number of value-added risk assessment activities. These include providing reassurance to management and the board that:

• Key risks that affect both value preservation and value creation have been identified.
• Different scenarios have been assessed and stress-tested.
• Inherent versus residual risk has been reliably assessed.
• Residual risk appears to be within the risk appetite of the company.
• Controls are both effective and efficient.
• Management's reports can be relied on.

What's Your Risk Intelligence Quotient?

To determine if their current risk-assessment models are risk intelligent, CAEs should ask themselves the following questions:

• Are we speaking the language of management?
• Are we assessing risks to future growth or are we focused exclusively on the protection of existing assets?
• Are we assessing risks in isolation or are we looking at how these risks may interact and cascade?
• Is there a uniform framework to align the various risk specializations regarding governance, risk, and compliance assessments, which will allow us to reduce the cost burden on the business?
• Do existing risk assessments reliably and adequately assess inherent and residual risk exposures?
• Do we have the means to assess whether residual exposures are within the risk appetite of the company?
• Is there a robust risk-mitigation process?

CAEs can play a unique and important role in the risk intelligent enterprise. While recognizing that management and the board are responsible and accountable for risk, CAEs should provide both guidance and reassurance that risk is being properly and efficiently managed.

Author of this article are Mark Layton and Neil M.Brown.

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