Quality Assurance (QA), Quality Control (QC) and Industry 4.0

Quality Assurance (QA), Quality Control (QC) and Industry 4.0

Written by: Shauna Clizbe, Business Development Manager

The biomanufacturing industry is currently undergoing a revolution in how it develops products. This paradigm shift is known as Industry 4.0. Industry 4.0 focuses on how to apply predictive modeling, data, analytics, artificial intelligence, and automation technology for the Digital Transformation of biomanufacturing manufacturing. 

Companies are investing in improved analytics, process control, and more of the elements of Industry 4.0.  Examples include using data and analytics from raw materials and bioproduction operations to improve the process with the goals of improving efficiency, lowering costs, and getting products to market faster. Quality Assurance (QA) and Quality Control (QC) are of utmost importance in the production of API’s, pharmaceuticals, and biopharmaceutical products, not just to meet Good Manufacturing Practices (cGMP) standards and regulatory requirements, but as a major tool in the Digital Transformation.  Processes and controls must be effective and enforced throughout your facility and process, from clean room operations to calibration of instruments and preventative maintenance in utilities systems.
Quality Control
While investing in better automation and analytics, biopharma manufacturers can take advantage of modular, pre-validated, and pre-tested single-use equipment, bioreactors, and chromatography systems that include built in electronic batch record (EBR) and manufacturing execution system (MES) functionality.  Integration of these complex systems with a QC and QA team can be a complex and sometimes difficult task.  Quality Control and Quality Assurance play inter-related and essential roles.  Creating successful QC and QA programs within the organizations can be streamlined by following some best practices;

  • Train your staff;
  • Documentation is key, especially in the age of Industry 4.0;
  • Perform at least an annual review of SOPs, policies, and programs;
  • QA and QC must enable your efforts, not disable them;

Be independent of the rest of the organization;

Creating QC and QA programs in any regulated industry is essential for success; contact PSC Biotech to learn about our Quality Services and Programs today!

What is Gap Analysis and how is it conducted?

What is Gap Analysis and how is it conducted?

What is Gap Analysis?

Gap Analyses is the systematic, documented review of an organization’s current state to identify gaps or opportunities for continuous improvement in “whatever”, be it quality systems, corporate governance, process optimization, operational efficiency, internal audit, or financial reporting. Biotechnology, Life Sciences and Healthcare organizations conduct gap analyses as a part of their continuous improvement programs.

What do Gap Analyses tell us?

Gap analyses tells you what you are doing now, how it compares to the current state-of-the-art, and what you need to do to bring your practices up to the current Good Practice used in your industry.  You and your team work to close these ‘gaps’ and improve your systems and efficiency.

How is Gap Analysis conducted?

Audit companies conduct gap analyses in five phases;

Phase 1 – Planning and Preparation

This is the phase where the scope of analysis, problems, goals, and tasks are planned out. A gap analysis questionnaire is formulated along with the content, format, and schedule to conduct the gap analysis.

Phase 2 – Reviewing Background Information

In this phase, we review documents, reports, and evidence.

Phase 3 – Interviews with Stakeholders

Managers, process owners, service managers, and management personnel are interviewed in this phase. The interviews are based on the questionnaire prepared in Phase-1 of the analysis planning. This is crucial to identify and establish problems, inefficiencies and a common consensus about the goals that need to be achieved post the gap analysis, and possible solutions.

Phase 4 – Review of Draft Gap Analysis

In this phase, the stakeholders, teams and other personnel can review the result of the analyses from previous phases. It is the final step whereby the stakeholders can ensure that all the gaps have been included and nothing is missing in the draft Gap Analysis.

Phase 5 – Delivery of Final Formal Report

The final formal report contains the findings within the processes, systems and patterns of operation of the organization. Here, the stakeholders can add notes in the formal report to include the recommendations for short, medium, and long-term goals to make your gaps “disappear”.

Need a gap analyses audit expert? Contact PSC Biotech for cutting-edge quality engineer gap analysis expertise.

Process Improvement – Cut Complexity Costs

Process Improvement – Cut Complexity Costs

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Written By: Conor Smith, Technical Writer, Midwest

[/vc_column_text][vc_btn title=”Learn More” color=”orange” size=”lg” link=”url:https%3A%2F%2Fwww.pscsoftware.com%2Fcontact-us||target:%20_blank|” css=”.vc_custom_1586897434053{border-bottom-width: 15px !important;padding-bottom: 15px !important;}”][/vc_column][/vc_row][vc_row][vc_column][vc_single_image image=”2609″ img_size=”full”][vc_column_text]Quality Document (QD) organization and scaling is an important consideration. There are a number of reasons for establishing and maintaining QDs and many challenges associated with managing QDs are consistent across different industries and applications.

One such challenge is complexity costs. In general, complicated systems are more difficult and expensive than simple systems (the exception proves the rule for complexity costs). A set of complicated and inter-related documents requires much more time to update than a simple set of documents. In part, this is because QDs typically cross-reference other related QDs. Updating one document requires modifying other documents as well. As a system of documents becomes more inter-related, the time to modify elements of the system vs. the total number of the elements of a system is more accurately modeled by an exponential curve than a linear approximation. Taken to the extreme, an accurate model incorporates the fact that in practice, very large numbers of documents become impossible to update. The following example in Figure 1 is aggregated and simplified based on experience in the pharmaceutical industry:[/vc_column_text][vc_row_inner][vc_column_inner width=”1/4″][vc_single_image image=”2613″ img_size=”full”][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]Figure 1: A simple model of Time vs. # of Documents to Edit. Document editing time is not linear (blue line) vs. the number of documents. Instead, the actual document editing time is exponential (red line) vs. the number of documents. The difference (dotted green line) between the curves could be interpreted as the true added value of harmonization. A. For a small number of documents (20) the difference in editing time is small – 40 days for ‘ideal’ vs. 49 days for ‘actual’ – a difference of 9 days. B. For a larger number of documents (40) the difference in time is larger – 80 days for ‘ideal’ vs. 119 days for actual – a difference of 39 days.

Linear model (ideal): Assuming 2 days editing per document, decreasing the number of documents from 40 to 20 would save the company 40 days in editing time. In other words, ideally, a 50% decrease in the number of documents from 40 to 20 is a 50% decrease in editing time.

However, for a complicated system the editing time exponentially increases with the number of related documents.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Exponential model (actual): Decreasing the number of documents from 40 to 20 saves closer to 70 days in editing time. In Figure 1 on the ‘difference’ curve, going from point ‘B’ (39 days difference for 40 documents) to ‘A’ (9 days difference for 20 document) is 30 days. Thus, the complexity savings is ~ a month of editing time. With the exponential model, a 50% decrease in the number of documents from 40 to 20 is a 58% decrease in editing time.

All this really means is that there is value in reducing complexity costs and that. quantitatively, the value is greater than if there was no cost associated with complexity. In practice, there are many strategies for reducing the costs due to complexity. One simple example is a reduction in the number of documents:

Finally, the most cost-effective strategy is to mitigate complexity costs by organizing QD systems before they become overly complex. PSC Software’s highly configurable electronic Quality Management System (eQMS), ACE™, is designed to provide the framework for a highly organized and integrated QD system. Additional offerings including consulting, project management and execution services will optimize your system processes, and prevent run-away costs due to unnecessarily complex documentation. For more information and to schedule a free demo, click here: https://www.pscsoftware.com/contact-us[/vc_column_text][/vc_column][/vc_row]

Why Gap Assessments are Important to Accelerate Success

Why Gap Assessments are Important to Accelerate Success

 

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

Are you finding yourself with repeated deviations or complex processes that slow you down? Did you go into an audit feeling ready and came out the other side blindsided by a 483?

Making multiple changes in processes over time, whether to prevent deviations or adapt to changing regulations, may create hidden obstacles, unnecessary or redundant steps, and broken links in procedures.  You may end up with standard operating procedures that no longer talk to one another properly, thus creating more deviations when an employee gets confused.

Identifying your desired state of operations and seeing your future state operations can be overwhelming.  How do you get to your future state without stopping and starting all over?  A gap assessment can help identify broken links and streamline processes to accelerate your success.

A gap assessment will compare your current state of operations to your desired state of operations.  In doing so, the analysis will identify gaps and areas of improvement.  In general, the steps of a gap assessment include:

  1. Identifying and documenting your future goals or desired future state of operations.
  2. Identifying and documenting your current state of operations.
  3. Comparing the current state of operations verses the future state of operations.
  4. Using gap analysis tools, such as Ishikawa, to find potential gaps and identify potential solutions.
  5. Evaluating the potential solutions by developing a plan to test one of the solutions.
  6. Testing one of the potential solutions with a small-scale study to see if processes improve.
  7. Analyzing the results of the study.
  8. Creating a plan to bridge the gap and implement the successful change into the routine process.

PSC Biotech™ provides custom fit options to help companies perform gap assessments of their operations.  Because regulations and guidance documents are periodically updated to help the industry adapt to current Good Manufacturing Practices, adjusting to the changes can be difficult for small and large companies alike.  Experienced consultants are available to perform gap analysis to ensure your current processes are compliant.

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!