Is Project Management Really Necessary?

Is Project Management Really Necessary?

Project Management is the Key to an Organization’s Success

Written by: Ryan Cox – Business Development Associate I

Are you wondering if Project Management is necessary? Well, with effective Project Management you can ensure that you will not be wasting time, resources, and budgets ever again because your projects are being run incorrectly.  

Project Management is an important tool in any industry. Projects are the organizations way to realize their strategic objectives. Organizations want to implement their goals and strategies but sometimes struggle to do so on their own. The best way to ensure you achieve your goals is to have a Project Manager successfully run the project, ultimately enabling you to realize your strategic initiatives. PSC’s Project Managers accomplish this by working closely with clients throughout the entire Project Life Cycle, to ensure the project is completed successfully, on time, and within budget. 

An effective Project Manager gives you a tremendous opportunity to increase efficiency in both time and resources. A Project Manager ensures that project teams are following a standardized, well thought-out, methodical approach. When your company has standardized Project Management methodology, if a team member leaves a project you can quickly onboard a replacement to fill that gap. Not only does it become easier to fill gaps within projects, but it allows for project continuity in your planning and execution with direction and focus. Your Project Manager ensures you are looking at all the critical aspects of the project, the Scope, Budget, Schedule, and Risk. Your Team, Quality, and Stakeholders all have the tools for your project to succeed. When projects succeed, organizations do too. 

As PSC Biotech Follows the Project Management Institute’s Best Practices and ISPE’s Good Practice Guide, PSC Biotech has been providing clients in a variety of industries with superior Project Management services. We not only focus on delivering successful projects, but also on creating solutions for the future. Contact PSC Biotech today to learn more about how our skilled Project Management team can help you complete current or upcoming projects to the highest standard on time and within budget. 

Securely Emerging into the Quality Nebula

Securely Emerging into the Quality Nebula

Quality Document Management Success

Written by: Candice Snine, Business Development Manager, PSC Biotech™

Quality Management in any industry is all about documentation.  If it isn’t documented, it didn’t happen.  Every detail is scrutinized, and document perfection is the ultimate definition of success! In the food industry, the quality group makes the team performing the daily tasks that run the business successful. Without the approval from quality, production cannot move forward to create that product that we are all waiting for. What goes on inside the quality nebula, you may ask?

The daily operations of the quality department encompass some of the following tasks:

  • Quality Technicians perform production checks to ensure specifications are met on products being manufactured. Production checks may range from 100% at-line inspection to sampling every hour depending on the company’s procedures.
  • Quality Technicians perform organoleptic, microbiological, temperature, volumetric, and other process checks and quality testing depending on the product being produced and customer requirements.
  • Quality Supervisors document and manage change control procedures, deviations and Corrective Action Preventive Actions (CAPAs) that stem from internal and external audits.
  • Quality Supervisors answer customer questionnaires and inquiries.
  • Quality Supervisors maintain certifications such as Halal, Organic and Kosher through managing documentation requirements.
  • Quality Specialists conduct and resolve Customer Complaint Investigations.
  • Quality Supervisors manage audits from internal and external parties through documenting findings and CAPAs.
  • Quality Supervisors and Managers conduct department training with cross functional teams to ensure quality standards are known and being applied.
  • Quality Specialists write, review, and approve Standard Operating Procedures (SOPs) and update current SOPs to adhere to workflow changes.
  • Quality Supervisors and Managers manage the Food Safety Program which includes annual review of the HACCP plan.

All this activity generates documents and document management is the key component that enables any quality team to be successful! Quality without a structured, documented, and automated electronic quality system is like flying through that quality nebula without your seatbelt, it will get bumpy!

Contact PSC today to learn more about how our cloud hosted software solutions, ACE ™, ACE Essentials and AuditUtopia® can help you to automate your company’s document, training, and compliance processes!

Disinfectant Efficacy Testing: Being Prepared is Half the Battle

Disinfectant Efficacy Testing: Being Prepared is Half the Battle

Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA, PSC Biotech™

Disinfectant efficacy testing is a means to measure the effectiveness of disinfectants that are employed to clean, sanitize, or disinfect surfaces. It plays an important role in controlling microbial contamination on surfaces. 

There are many regulations and guidance documents that discuss disinfectant efficacy testing and the topic is fair game in regulatory audits. There three well-known versions of the test, the use-dilution test, surfaces challenge tests, and in-situ field studies.  

The use-dilution test is also known as in-suspension studies. It is a quick screen that can be performed with new environmental isolates that are found in environmental monitoring. It is not a replacement for the surface challenge test. Simply, you inoculate approximately 1 X 106 CFU of the microorganism into 9.9 mL of the working disinfectant solution.  After the allotted contact time has expired, you process the solution and test for viable microorganisms.

The surface challenge test, also known as the coupons study or the carrier surface study, is the most common method for testing disinfectant efficacy. It involves using coupons made of the materials that are the surfaces in your facility. You should use a risk-based approach to select the worst-case surface coupons, microorganisms, disinfectant working solution concentration, and wet-contact times for the test. You inoculate the coupon surfaces with microorganisms, dry the surfaces gently, and then apply the disinfectant as it would be in the manufacturing environment. After the allotted contact time expires, you process the coupons are processed to test for any remaining microorganisms.

The in-situ field study, also known as statistical comparison tests, is performed in the manufacturing facility, most commonly before and after an area start-up or before and after cleaning and disinfection during normal operations. Simply, environmental monitoring (EM) is performed in the “as is” or “dirty environment”, the area is cleaned, and then the EM is performed again. The results are compared to determine the decrease in microbial numbers.

The best way to present disinfectant efficacy testing to regulators is to be organized and have your data ready in a neat package. Establishing a compliant disinfectant efficacy testing package aids in providing clear documentation that the disinfectants employed in a facility have been analyzed correctly. 

PSC Biotech™ can help ensure your disinfectant efficacy studies as well as your facility and procedures are ready for a regulatory audit. Our professional services team can perform cGMP audits of your facility, including your disinfectant efficacy testing. We can help you prepare to present and discuss your data with confidence during regulatory audits of your facility. Contact us today!

PSC Biotech™ and BIO Business Solutions® are hosting a joint webinar on the Fundamentals of Disinfectant Efficacy Testing. Click the button below to register!

Do not Stop at Low Hanging Fruit – Process Improvement Should be Ingrained in Your Culture

Do not Stop at Low Hanging Fruit – Process Improvement Should be Ingrained in Your Culture

Process Improvements Can be Big or Small and Are Essential to Your Culture 

Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech™

When we think of process improvements, it is often easiest to pick the easy quick wins to keep our management happy (e.g. low hanging fruit). However, the real question should be “Why do we have these easy wins?”. The continual improvement process (CIP) is an ongoing effort to improve products or processes. It works best when every employee feels empowered to recommend and implement changes, no matter how small.

Tools such as Kaizen, Toyota Kata, and PDCA (plan, do, check, act), can help your organization implement continual improvements. Small incremental changes can come from the employees themselves and can make them feel engaged with the company processes. Small incremental changes that are continuous over time can be easier to implement and may not require a capital investment.

One example of an incremental change involves environmental monitoring employees spending about an hour each day gowning, degowning, sanitizing supplies and carts to go into clean areas. The employees would prepare a cart with the supplies, push it down to the clean area. In the pass thru, the employees would methodically remove all the supplies from the cart, disinfect the carts, the cartwheels, and supplies. Then, they would push the cart over the demarcation line, gown in, and retrieve the cart on the other side. The employees would repeat this process until they were at the inner core of the cleanroom (4 times) and then would work their way out of the clean area sampling the environment as the progressed.

An employee had a great idea and approached management about a small change. They could save time, effort, and increase efficiency if they had cleanroom dedicated carts. The carts would be a one-time investment and would be labeled and staged for environmental monitoring use only (Plan). The carts were purchased, cleaned, and staged in the clean areas (Do). During the next cycle of environmental monitoring, the employees were timed and monitored. They pushed the loaded carts down to the clean area and began the process of disinfecting and transferring the materials into the clean area with dedicated carts. They gowned in and proceeded as normal. They saved 10 minutes at each transition every day (40 minutes a day) for a week (Check). This added a little over 3 hours of extra time per environmental monitoring employee per week, thus saving the company money and giving the employees more capacity for other projects. This small incremental change was so successful, it was implemented into the routine process (Act).

There are thousands of examples of employees suggesting “obvious” changes that allow them to be more productive and produce a higher quality product. Process improvements can be big or small projects. They require input and buy-in from the CEO to the front desk.

Need help building your roadmap for your continual improvement process? PSC Biotech™ provides custom fit options to help companies with process improvements. Experienced consultants are available to teach you the tools for process improvements so that the concepts of continual improvement can become ingrained in your culture.

PSC Biotech™ has a wide variety of solutions to ensure success for any size company. Some of our offerings include consulting, performing risk assessments, writing standard operating procedures, writing protocols, writing white papers, project management or even executing projects to free up your company’s valuable resources. Whatever your need may be in the life science industry, PSC Biotech™ will be there to help. Give us a call today!

What a Difference an “E” Makes When it Comes to World Class Quality!

What a Difference an “E” Makes When it Comes to World Class Quality!

Stay in Complete Control with an Electronic Quality Management System 

Written by: Cindy Gross, Product Manager  – ACE Essentials 

When you work in a highly compliant industry, quality can make or break your company. While paper-based quality management systems will work, and have for years, it may be time for you to consider moving to an Electronic Quality Management System. Starting with the words “Real Time” and ending with “It’s right here” will have you in full control when it comes to connecting quality and reducing risk. 

What are some of the “E”ssential reasons to consider an eQMS?

Better and Advanced Data Management – Using an Electronic Quality Management System allows the possibility for real-time management of all recorded data. Avoid the risk of non-compliance.

Faster and Better Accessibility  An Electronic Quality Management System ensures that it is quite easy to access records anywhere you go by simply having an internet connection.

Association of Quality Events – The right eQMS will let you follow the quality actions that take place from inception of a Complaint, Deviation or CAPA to completion with ease.

Metrics and Reporting – Create dashboards and reports to manage the day to day and to uncover trends quickly.

Eliminate Waste – Using an electronic, web-based system instead of a paper-based system saves time, resources and money.

BONUS – Inclusive Learning Management – Best in class Electronic Quality Management Systems will include a Learning Management System for immediate release and capture of training.

Having a Quality Management System (QMS) in place to create and store your policies, processes and procedures required for planning and execution of any of the core business areas of an organization, will impact the organization’s ability to successfully meet customer requirements and please investors. 

ACE Essentials Logo

PSC Software™ offers ACE Essentials™ as a cost effective, turn-key solution for Document, CAPA, Deviation and Learning Management that can be operational as soon as you flip the “on switch”. Reach out to us today to learn more about how to make your company E”xcel in quality.

Beyond Read and Understanding Training

Beyond Read and Understanding Training

By: Priscilla Jones, Talent Acquisition Specialist, PSC Biotech Corporation  

What is Read and Understanding Training? 

Anyone who has worked in a procedure governed organization is very familiar with “read and understand” training. “Read and understand” training typically involve reading a document and then signing an acknowledgement statement to document understanding. For many years, this was good enough to show training records as evidence of trained employees. Then regulatory inspectors started asking about the effectiveness of these training programs, so sometimes quizzes were added at the end as a way to measure knowledge retention and comprehension of the information. But the quiz is still no guarantee that the employee retained the information and turned it into a skill that can be performed on the job.  

Why is it Problematic? 

This technique can provide organizations with a quick and inexpensive way to share information with their employees, but it can also be problematic because many employees don’t recall the information accurately. This lack of recall can be due to various factors including: 

  • Employees are not actually reading the document 
  • Employees are just scanning the document, rather than thoroughly reading it 
  • There are issues with the document itself and the key information is not apparent to employees 
  • This technique does not necessarily give employees the means to feel confident completing tasks in the documents on the job 

What is the Solution? 

Read and understand courses may not be the ideal method for training employees, but many organizations rely on them in some form to train their employees. So how can those who create read and understand courses make them more effective and help ensure employees remember the information they just read? The solution: enhancement and engagement from the employeeCreating and incorporating interactive content into a read and understand course can provide organizations with more effective training. 

An interactive summary will enhance the read and understand course, as well as recall and retention, by walking the employees through the content and technique before they sign off on the document. An interactive quiz can be even more effective, as this allows the employee to recall the information and apply the knowledge based on the training content.  

That will help with recall and retention of the information, but is this technique effective in training employees? As a means of accessing information, yes. But reading a procedure is not the same thing as training on an SOP. Training is gaining the knowledge and skill of a technique, putting them together with practice, and applying both on the job. Training can be considered effective and successful when these procedures or techniques can be accurately performed on the job without coaching.