Qualtrax Compliance Software

Your customers require audits and third party certifications. The industry is embracing tools and automation as the complexity and importance of compliance is increasing. You are not the only one that feels the stresses associated with compliance. We’ve helped others, and we can help you. Managing compliance requirements and taking appropriate action is much simpler when you use Qualtrax ISO compliance software.

Problem: Tim has requirements to meet ISO 9001, has bi-annual audits, and has specific customers visit nearly every month. He can’t afford to be burdened with inefficient processes and administrative tasks. He needs to know at a glance what’s happening, where we are at any point in time and be able to act swiftly to address key compliance issues so he’s ready for an audit anytime.

Solution: Using Qualtrax, Tim is able to easily assess all of his requirements by each standard or even deeper by individual element of the standard. Tim can now associate any key process or document to the associated standard or sub-element of the standard. So, if Tim needs to know what corrective actions have been issued over a certain period of time or what key documents still needs to be approved for compliance to section 7.5.2 of ISO 9001:2000, it’s all there at his fingertips and just a couple clicks away. Plus, now he can quickly track down responsible parties and ensure on-time completion of record reviews, trainings, and inspection logs in minutes using ISO compliance software.

Your operation has a tremendous amount of documentation to keep up with. In a paper-environment, document retention takes up an enormous amount of space—even if you're using a network drive to store your documents electronically, there are so many revisions to store that it's easy for that drive to get ugly and unmanageable, fast! When you're retaining documents for extended periods of time, this quickly adds up. Now, tracking the history of all of these documents is a big task to wrap your arms around but is a requirement for your organization.

Problem: Maggie is looking through files on her company's network to try to find the most recent revision of her company's Standard Operating Procedures (SOPs). There are several versions of the SOPs, and she needs to make sure that she pulls the most recent version for the auditor to review. If it's this hard for her to locate, imagine how it must be for every other employee of the compan.!

Solution: Using Qualtrax, the SOPs are searchable and easy to navigate to through the browse tree. Maggie can also see all of the past revisions of the document in the event that she needs to go back through and see when the document was last updated, who it was updated by, and what changes were made. This is true of every document in the system!

You handle a lot of information that visitors and auditors don't need to see, but that you definitely need to have record of in your system. Every single document you put in Qualtrax can be given specific view and edit permissions. This allows your company complete control over who can see and edit your documentation. This also eliminates the need to have confidential information sitting on a shared drive or in a binder/filing cabinet.

Problem: Matt is a production manager wants to make sure that certain documents are only viewable by a specific group of employees in the department. In a paper system this means that a handful of employees are given security privileges to certain paper documents, and in an electronic environment these employees need to have access to certain folders on the network. Now, the trick is making sure that these sensitive documents only appear in these limited locations. In addition, as employees come and go at the company, Matt has to keep these permissions current.

Solution: Using Qualtrax, Matt can set up groups in the system and give them specific permissions to view and edit specific documents. This guarantees that only employees with certain security permissions can access sensitive documents. As users are added or deleted from the system and put into groups in Qualtrax, these permissions will automatically be granted to the appropriate employees. Matt can rest easy knowing that sensitive documents have the security they need. Using Qualtrax permission settings is also a great way to ensure that all employees see documents that pertain to their job function, and this helps you limit what "view-only" guests (such as auditors) are able to access when they visit your company.

Every business has several processes that require paper passing. Equipment calibration, purchasing requests, paid time off requests, chemical tracking, customer complaints, and others are all processes that can get lost on someone's desk or email inbox. It's a waste of everyone's time to try to track down the next person in line to ensure a process is pushed through to completion, and it can be very time intensive to determine the status of a process. Processes are a reality for every business, and handling them isn't always easy.

Problem: Mike is trying to put in a vacation request for his summer trip. He's filled out the paper form with plenty of time to spare and given it to the his manager. Mike's manager has taken the vacation request and signed off that it's been approved. This request now needs to be sent to the HR manager, but the vacation request gets lost on Mike's managers desk once things in the lab pick up and more strain is put on the manager's time. The vacation request finally turns up, but only after Mike checked in with his manager to make sure everything was in order for him to leave town the next week.

Solution: Mike logs in to Qualtrax and submits his vacation request using a Qualtrax workflow. This request will route directly to Mike's manager where he'll get an electronic notification that approval is needed. Once Mike's manager has approved, the vacation request will be sent to the HR manager who will give final approval. At that time, Mike will get an electronic notification saying that his vacation has been approved and he's good to go! In some cases, customers will have approvals put a notification on a company-wide calendar, and let Mike's coworkers know that he'll be out. While this process is going on, Mike can log in to Qualtrax at any time and see where his request is in the approval process - this gives everyone visibility of what is going on and peace of mind that things are going as they should.

Trainings and certifications (and re-certifications, for that matter) are one of those things that somehow takes up more time than we'd all like them to. In a paper-system, pulling files is a long, hard way to make sure your whole company is up to date on trainings, and it's easy to overlook re-certification and training deadlines. Qualtrax will help you keep everything in line by notifying managers when trainings have expired, and when re-certifications are in order. All trainings can easily be reported on so that you can see where gaps in training requirements might exist.

Situation: Jim knows that he has met his standard training requirements but isn't sure when one of his re-certification trainings is due. He goes to his manager to ask them to pull his training records so he can plan his training accordingly. Jim's manager handles his request as soon as he can. Finally, they pull his record only to find that he has two incomplete trainings that should have been completed the month prior.

Solution: Using the Qualtrax training matrix, Jim logs in to Qualtrax and pulls up his training history. He can see all of the trainings that are available to him and whether or not they are required or optional. From here Jim can also see which trainings have been completed and which trainings still need to be satisfied. Using document management, Jim can also see when his certifications expire. Jim's manager can also use the training management piece of Qualtrax to quickly run a report to see who has completed necessary trainings and where employees still need some attention.

Managing Customer Complaints from inception to resolution is critical to maintaining customer satisfaction, supplier standards, and regulatory compliance. Paper-based processes are time-consuming and drain valuable resources.

Problem: Heather just received a customer complaint phone call from their largest customer. She emails Scott, the QA Manager, and informs him of the non-conforming product that was received by their customer. Scott then has a discussion with the shipping department and accounts payable informing them of the refund and replacement. Scott then emails customer service and the sales department to inform them of the issues resolution. Only after all this time and multiple departmental interactions is the process documented.

Solution: Heather received a customer compliant and instantly opens Qualtrax and launches a workflow to record the details of the incoming complaint as the customer discusses the issue. She clicks a button and an email with a summary of the issue is sent to all affected departments. Each department is assigned tasks to complete within Qualtrax to resolve the complaint. Priority is established and documentation and audit trails automatically are recorded with each department and individual actions. Time to resolution and administrative work has been dramatically reduced.

Corrective and Preventative Actions are the backbone of an effective quality management program. Without an effective system for documentation, timely response and reaction, and subsequent preventative programs implemented, the result can be very costly. The problem most companies have is not documenting the corrective actions but being able to provide a timely response through resolution, demonstrating an audit trail of actions taken and assigning a responsible party for each step of the workflow.

Problem: Susan is currently trying to keep up with four different CAPAs from various departments within the company. Each CAPA is in a different phase of completion. Keeping track of progress and communicating progress to the necessary parties is a time drain.

Solution: Susan gets each CAPA started electronically in Qualtrax. Susan can set up daily reports to come directly to her email to track each CAPA’s progress. The different steps are routed from person to person electronically with automatic email reminders, so Susan’s day is suddenly open again and she no longer needs to spend her time worrying about each CAPA’s progress. The information she needs comes directly to her inbox.