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Risk Management Tools That Help Your Business Stay in The Clear

Risk & Opportunities

Whether from regulators, shareholders, or the need to  address the guidelines of ISO 31000 and ISO 14971, the pressure to implement a formal, well organized risk management program has never been greater.

The TLM Risk & Opportunities module in TLM provides your company with a robust, yet flexible platform of risk management tools that are integrated throughout the software enabling risk management  implementation that’s just right for what your company needs.

With TLM Risk & Opportunities you can use individual Risk & Opportunity analysis records from almost any other TLM record as part of your customized risk management effort. Risk analysis efforts can either be part of a dedicated and concentrated effort using a TLM Projects record as a central hub for all risk management activities as shown below.
  • Use the Projects Module to establish a Risk Management Plan and link to multiple R&O records.
  • Includes Asset Reference links to support IT Security  ISO 27001 Projects.
  • Before and After mitigation RPN numbers.
  • Multiple Approval capabilities.

Risk evaluations can also be triggered as QMS events unfold in other TLM modules according to your documented risk management policies.

  • Customizable RPN color codes.
  • Track Mitigation Costs.
  • Integrated with the TLM Dashboard and Emails.

Risk & Opportunities

Nothing Falls Through the Cracks!

Total Lean Management (TLM) Software provides a dual technology, upstream/downstream digital landscape to both easily create and find needed records, AND connect records that are a result of work flows, such as Risk & Opportunities and the other TLM records that are related to them.
The Risk Priority Number (RPN) is the most widely used risk evaluation method that defines the risk as either a three factor or two-factor number.

Three Factor RPN = Severity x Likelihood x Detection

Two Factor RPN = Severity x Likelihood

Each component of the RPN receives a 1-10 value, and by multiplying them together a final RPN number is determined.

Total Lean Management (TLM) Software can be configured to use either strategy in system settings.
Fusion Technology is what happens when information integration creates a higher-level management system beyond individual workflows. The TLM Risk & Opportunities Module in TLM incorporates this technology by integrating with other TLM solutions to create a Total Lean Management Software approach that provides all stakeholders with a picture of inter-related QMS Software events across your entire organization.

It also serves to create the foundation of your company’s digital landscape which saves you as much as possible from purchasing a disconnected stand-alone software and provides the technical support for integrating other information systems when necessary.

All TLM software modules are rolled up to a user specific dashboard and summaries of each user's dashboard can be automatically emailed to ensure QMS activities are scheduled and prioritized accordingly.

In addition, the TLM dashboard helps users navigate to where tasks are performed, making it easy for new users to adopt the software without having to pay for extra training before being able to put TLM software to work for your company.

Not only are all the requirements in any ISO QMS standard essentially based on identified risks, many of these standards also include requirements for specific risk management activities.

Even if you aren’t compelled from a compliance standpoint to conduct formal and organized risk assessments, doing so has several key benefits such as:

  •  A risk management plan can help your bottom line.
  •  Money spent on losses can be saved.
  •  A risk management plan makes for consistent and efficient operations.
  • Having a risk management plan is fiscally prudent.
  • A risk management plan improves a company’s brand.
  • A risk management plan leads to more satisfied customers.

The best possible quality management system allows you to take a risk appropriate approach to your documentation, records, and risk analysis efforts for two simple reasons.

  • Doing less than necessary will increases the risk processes are not controlled, employees are not trained, and risks are not identified, all of which will drag the company down in reactionary “fire fighting” efforts to deal with the results of inadequate QMS controls and the inevitable surprises that will result.
  • Doing more than necessary will simply waste time and resources with activities that are not really making a significant difference compared to a more modest effort for any given risk or QMS procedure or quality record.

Total Lean Management (TLM) software was designed from the beginning with this requirement in mind which resulted in the custom fields, system settings, rapid updates, and Fusion Technology integration between modules to allow a company to implement a risk-appropriate detail-based QMS.

The risk and opportunity module can be directly applied to this effort, as demonstrating a risk evaluation was performed as justification for limited compliance efforts can save your company thousands in the long run compared to paying the wages for someone to spend time on more elaborate efforts that are just not realistically necessary.

Of all the factors that drive human behavior, whether positive or negative, none are as universal as the need to evolve, whether we are conscious of it or not.

Your management team can create impressive organizational growth by harnessing this basic element of the human experience and the TLM Risk & Opportunities module is part of the key tools that will make your QMS software successful.

By organizing key aspects of how work is done, managers can use TLM Risk & Opportunities software to empower employees to participate in finding opportunities for improvement and customer satisfaction while maintaining approval control to ensure additional risks aren’t introduced.

The TLM Risk & Opportunities software module ensures these efforts are well organized, linked to all other aspects of the QMS software that might be related, and assigned to ensure employees who rise to the occasion can be recognized accordingly, and are motivated to do so as a result.

Historically the decision to implement ISO was driven by the consequences of NOT being ISO certified when competitors were using ISO certification to win new business from customers who needed confidence in their supplier’s ability to consistently meet requirements.

This resulted in a lot of paper based systems set up by various “consultants” that advocated vague procedures that could technically meet the requirements of the ISO standard, but in reality did very little to improve quality or any other aspect of the business.

Times have changed, and the introduction of QMS software allowed organizations to take a different approach to their quality system and instead of wasting tons of time and money for little benefit, they are using their QMS to improve all aspects of the business.

At least the companies who could afford the high cost of most QMS software.

The whole point of ISO based quality standards is to address the minimum risks across every aspect of the business that could have consequences to customer satisfaction.  Unfortunately, by calling them “quality” standards, a misperception developed over the years that caused managers to think of quality as something the “quality department” was responsible for.

Total Lean Management (TLM) Software corrects this misperception by acting as an integrated management tool not only for compliance, but as the framework for how a company evolves.  Audit management software can be a vital component of this evolution, provided it is integrated with all the other aspects of the business to make auditing easier, faster, and more insightful.

There is Only One Type of Quality Management System


Over the last 20 years TLM has discovered a very basic truth when it comes to information management systems such as your eQMS, no two companies have the exact same needs.

In fact, the two biggest risks in the software selection process is either selecting software that is not flexible enough to manage information that is unique, and important to your workflow, thus forcing work arounds, or other concessions that effectively add waste to your business.

The other mistake is getting stuck with comprehensive, but inflexible systems due to their web based cloud hosting design, which forces a one size fits all approach to meeting customer needs.

And while one size might fit some, it might not fit all your needs when in the long run your understanding of those needs evolves and improves.

Total Lean Management Software, by definition, recognizes this fact, and addresses it through a dual technology, upstream / downstream user landscape approach to meeting the needs of both your upstream and downstream user types.  This is combined with our tiered approach to addressing newly discovered customer needs, making sure the software works in alignment with your business systems the day after your purchase, and for all the years ahead.

These measures include:

Custom fields

Allows you to adapt the software to your company’s terminology.

System Settings

Allows you to choose which features are applied to your process.

Rapid update cycles

Incorporating employee feedback into the continuous improvement cycle creates a synergistic effect on moral, engagement, and productivity.

Development Projects

This capability provides insurance that your system will never leave you stuck after discovering unknown needs after implementation.

High levels of interlinking

By implementing and combining modules in way that might be unique to your business or work flows.

World class customer support

Evolution is a team effort, and the whole team behind TLM enjoys helping companies comply with regulations, manage risk, continuously improve, and maintain a steady growth rate.

Help Files can be Linked to your Controlled Work Instructions

This unique TLM feature allows you to link individual screens in TLM to your own controlled procedures or work instructions for that area of the software (if needed).

Why TLM is your Best QMS Software Choice

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If you have any questions or want more detailed information, do not hesitate to call us.

If you have any questions or want more detailed information, do not hesitate to call us (866) 209-6896.

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TLM Customers are always our top priority -David Smithstein, CEO

“In the 10 years that we have relied on TLM to manage our quality documents, it has grown to become the core of our QMS. Our QMS has been audited by BSI, TUV, SAI, FDA, Canada Health and CDPH . We survived all of those audits and emerged a better company. Thanks, David!”

Jim Klett

★ ★ ★ ★ ★
“EXCELLENT customer service! Without fail, David has responded to every question, email and phone call within a few hours. He is great to work with and always willing to help… TLM is a one-stop shop for all of our QMS needs … The training videos on the website are helpful- keep them coming!”

Allison Getz

★ ★ ★ ★ ★
“Very helpful in fine-tuning the software/reports to meet our specific needs for audits, even ones requested the day before the audit. The software is straight forward for use, we have 8 personnel in two different locations using it seamlessly … The best customer support I have ever used.”

Stewart Denham

★ ★ ★ ★ ★

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