Not Performing a Risk Assessment is a Risky Business

Not Performing a Risk Assessment is a Risky Business

Written by: Wayne Berry, Quality Process and Computer Systems Validation Manager

We perform risk assessments in every part of our life… choosing a safe car for our new teenage driver, making sure the car seat is properly secured for that newborn’s first ride home, wearing a helmet when biking or putting on a flotation device when out on the water.  Yet, there are times in our professional life that we are more focused on ‘getting things done’ today and not thinking about what could go wrong in the future.  And things do go wrong. 

A well-thought-out risk assessment program covers all aspects of our business and isn’t a one-time review when making changes.  The COVID-19 crisis has impacted everything we do and is shining the light on the strengths and weaknesses of our operations.  Now is the time to take a holistic review of how we have  historically  evaluated and rated  risks  in our operations.  We should review these risks and compliantly implement  new  adjustments to our  processes if necessary.

One area that may not receive the attention it needs is  our material suppliers.  We develop a level of comfort with established suppliers that have been dependable, consistent and provide quality materials.  And we lower the perceived risk that this supplier will fail us.  With COVID-19 impacting all businesses, how is it impacting your suppliers?  Will they be able to ramp up and meet your needs?  Will you be competing with their other customers for limited inventory?  Do you have alternate suppliers qualified and available to address any gaps? 

Thorough risk assessments allow us to identify and develop plans to address unforeseen problems in a controlled manner, allowing our resources to focus on instituting the solution instead of solving the problem.  Don’t let the lack of risk assessments turn a good business into a risky business.   Give PSC a call today!  We have experts standing by who can help with risk analysis and mitigation. 


A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Budget on Large Complex Projects

A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Budget on Large Complex Projects

Written by: Chandler Conley, Business Development Manager

Pharmaceutical industry projects are some of the largest and most complex many of us have ever seen. We all have a goal to supply safe and cost-effective therapies and products, which is why it is critical to stick to pre-determined budgets and schedules at all costs- pun intended! 

The question is, how is a project cost determined? One way is to consider similar projects as a baseline and point of reference. Did that project stay on budget? Is the cost realistic? How are the deliverables, scope, and processes in this prior project different from the project you are planning for? The process of staying on budget starts in the initial budgeting, proposal, and planning process. Invest the time to be clear about the scope of work for all parties involved and always try to be as realistic as possible to set the team and yourself up for success. Think about what steps are contingent on other steps… will the manufacturer of a piece of equipment have the equipment and accessories delivered in time to meet your deadlines? Are you giving your quality department enough time to review any documents they should? Will any materials or documents that you need to provide the project team be ready by the project start date? Also recall how long safety and onboarding will take for any new employees hired for this project, as this is frequently overlooked in project schedules. 

If you are outsourcing support to any service providers and requesting proposals, your point of contact is thinking about these things and also trying to develop a realistic proposal and schedule for you. I promise- they want to go over budget even less than you do!  

A fundamental part of project costs are hourly rates. This is a double-edged sword. Having a senior/experienced person may be able to complete a task in less time, which is helpful for project schedules and will result in less labor hours charged. That being said, mixing in multiple experience levels can ensure that people with the appropriate experience level are doing the required tasks. There may be some entry level tasks associated with the project, such as document control support and administrative tasks, so these can be good areas to save some money and utilize staff that are more junior. 

We find it is important to allow time for project management in a capital project, so budget should also be reserved for this. Once a project is rolling, a strong Project Manager will manage deliverables and schedules for you and can give regular updates on the project burn rate. They can also be your primary point of contact for the project. Hypothetically, if a team of 10 people are involved, you either have to communicate updates for changes to all 10 people, or you can communicate to the Project Manager who can then ensure the rest of the team gets the communication without taking up any more of your time, which is the option we recommend. 

A typical reason a project may go over budget is because some unexpected tasks were added. It happens! Some things like equipment repairs and major company direction changes cannot be foreseen. The best thing you can do in this case is keep track of added deliverables that were not in the scope and handle change orders as needed.  

In crunch time, resiliency and agility are important team characteristics when project issues occur that will help the team quickly spring back to efficiency. What we do is not easy, but with a proactive mindset, good tracking resources, and strong project management, you will be set up for success! 

All Aboard! The Importance of Having a Proper On-Boarding Process

All Aboard! The Importance of Having a Proper On-Boarding Process

Written by: Priscilla Jones, Talent Acquisition Specialist 

Many companies underestimate the importance of onboarding when they hire new employees. Several companies have no formal onboarding program at all, while most that do only have a partially successful process. Why is onboarding important? New employees that go through an unsuccessful onboarding process are stressed, less productive, feel disconnected from the rest of the team, and are likely to look for work elsewhere. This loss of productivity leads to a high employee turnover rate, costing companies large amounts of money.  

What is Onboarding? 

Onboarding is the process of integrating new employees into an organization. Not to be confused with orientation, which is typically a one-day event, that usually begins the onboarding process. Onboarding can continue for months to even years after an employee is hired. Proper onboarding increases employee engagement and helps get them up to speed with seasoned hires much more quickly. 

Benefits of a Proper Onboarding Process 

Reduces New Employee Anxiety 

We’ve all felt some nerves and anxiety before starting a new role; being a new employee can be very stressful. This stress can be reduced by employers by providing all the information that their new hire needs to fulfill their role. This starts right at the beginning of the onboarding process, during orientation. An orientation day gives new hires a first impression of the company and an idea of what they can expect working there in an informative, welcoming way. 

New Employees are Productive Quickly 

As new employees go through the onboarding process, they quickly get up to speed with the employees who have been with the company for longer. This lets them reach higher productivity levels much faster than if they had to figure everything out on their own.

Without onboarding, it can take several months  for new employees to reach their full productivity levels, which can result in overall loss of revenue  for a business. With onboarding, companies enjoy greater productivity from their new hires.  

The longest onboarding programs are the most successful. Most companies only spend a couple of months on the onboarding process, and a fraction of those don’t include any kind of training for the new hires. A minimum of 6 months is important because most employees decide if they will stay with a company within that time. Training and engagement during this time will help employees feel at home and comfortable in the company. After the initial 6 months, onboarding should slowly shift from a training approach to one that encourages continuous development. This continuous development will help employees see that they made the right decision.  

Employees Feel More Comfortable in Their Roles 

Proper onboarding procedures include training for employees. Training provides people with the knowledge they need to excel in their role. New hires are also taught about the mission and culture of the company, which helps them align themselves with these values. It also helps employees learn how to meet the expectations of the company. If you’re thrown into a job with no idea of what’s expected of you, how are you supposed to succeed? Employees need to know where their job role fits into the company and how their individual position is valuable. 

By aligning new employees with their role, they feel needed and important in the organization. This helps them associate themselves with the workplace culture, which leads to more engagement, employees are motivated to work efficiently, and are much less likely to look for other opportunities. 

Reduces Employee Turnover 

Employee turnover refers to the number of employees who leave an organization and need to be replaced. This is much more expensive than companies realize; the cost of replacing the average employee can be up to 20% of their annual salary. The good news is that turnover is very avoidable. Employees  are less likely to leave a company when they are engaged workers. Where can companies start on developing employee engagement? Onboarding! Introducing new employees to the company and engaging them with company values means they’re much less likely to leave your organization to look for an organization that better fits their work culture. 

Overall, a strong onboarding process results in much happier employees. It helps employees get to know one another and learn how to communicate effectively, which facilitates the building of relationships, resulting in friendships that are a very important element of a happy working life.  

Fear of the Unknown When Moving from a Paper-Based System to an Electronic System

Fear of the Unknown When Moving from a Paper-Based System to an Electronic System

Written by: Katie Favino, Key Account Manager, Midwest & Andrea Salive, Business Development Manager

Transitioning from a paper-based system to an electronic document and Quality Management System might seem scary at first, but with these helpful tips, watch your fears melt away! 

Value proposition is the key to successful changes in the way your operations are managed. There are so many benefits when transitioning to an electronic systemThink back to all those hours spent searching, updating and refiling documentation, to start; never mind when the FDA shows up and you need to gather all the documents related to just that one batch record I’m getting tired just thinking about it! Using an electronic Quality Management System (eQMS) keeps all files and records within an organization safe and sound and most importantly, instantly accessible from your phone, tablet or desktop!  

You may be thinking, “I have endless filing cabinets stuffed with important files and records, how will I ever be able to migrate them all?” If you have paper versions of your procedures, policies and templates, then you certainly have the word document versions which are easy to upload and begin the review process. The executed protocols and forms can be uploaded as a record and continue from their existing point in their lifecycle or be filed for safe keeping and be referenced later.  

The workflows in an electronic Quality Management System are configured to fit YOUR process, not the other way aroundWhether there are signatures you need collected or a critical circulation your documents must follow, electronic workflows have the flexibility to mirror whatever process you have implemented now. The factor that makes transitioning to an automated system even more efficient for your organization is that it doesn’t allow employees to deviate from the process you’ve implemented, therefore significantly decreasing the risk of human error. System validated Audit trails will capture every move made by a user within an eQMS, eliminating any questions associated to changes made within the system. 

Typically, the biggest hurdle organizations face when looking to upgrade their current processes is the fear of change. Electronic Systems are constantly improved and are designed to make your company’s day to day easier. A concept that can help accelerate and get everyone on board for this transition is understanding the benefits it can bring; knowledge is power. Keep in mind that not all electronic quality management systems may offer the solutions to meet your needs. Luckily, PSC Software’s highly configurable eQMSACE™can offer you a pleasant and painless transition. For more information and to schedule a free demo, click here.

PSC Software™ Has Developed a New Functionality in Our Industry Leading Real Time Inspection Management Software, ACE Inspection™, to Facilitate Remote Inspections and Audits.

PSC Software™ Has Developed a New Functionality in Our Industry Leading Real Time Inspection Management Software, ACE Inspection™, to Facilitate Remote Inspections and Audits.

Dear Life Sciences Industry, 

As of March 18th, 2020, the FDA suspended routine onsite domestic inspections until further notice in response to the COVID-19 pandemic. The FDA has signaled that they will implement alternative methods in order to continue inspections, including using remote applications. FDA will be releasing a revision to their Inspection Manual to address their remote inspection procedures and requirements. 

PSC Software™ recognizes the urgent need to continue both FDA inspections and other audits for our clients allowing your products to progress through the regulatory approval process while maintaining compliance. With this shift in how inspections will be performed, PSC Software™ has developed a new functionality in our industry leading real time inspection management software, ACE Inspection™, to facilitate remote inspections and audits. 

ACE’s Virtual Inspection Management functionality, currently slated for release in July 2020, will allow inspectors and auditors to securely and remotely view your records and documents in response to an inspection request record created in the ACE Inspection™ software. 

Once the inspection request record has been reviewed and reaches the proper status, ACE Virtual Inspection Management will allow the inspector to view the approved document and limited metadata associated with the document, through an encrypted viewing portal. This portal will have permissions that will give you the ability to: 

1. Limit permissions for the Inspector/Auditor, e.g. view only, download or other permissions. 

2. Set a timeframe of access for the inspector/auditor to the portal. 

3. Limit the metadata that will be visible to the inspector/auditor. 

If you would like more information regarding ACE Inspection’s Virtual Inspection Management capabilities, please reach out to PSC Software at 

Thank you, 

Tyler Howard 

Senior Manager, Business Development

(928) 308-9905