What happens when something goes wrong? CAPAs for Equipment

What happens when something goes wrong? CAPAs for Equipment

What is a CAPA? It is the acronym given to Corrective and Preventative Action, as defined by the FDA. A CAPA is triggered when a product, process, or documentation has a non-compliance issue. CAPAs can be triggered from small or large issues. A small issue might be repeated product loss from intermittent equipment error. Whereas a more significant CAPA trigger results from errors in product packaging that trigger a Form 483 from the FDA.

If you are in the pharmaceutical, biotechnology, or healthcare industries, you need proper CAPA support to bring your systems back to an acceptably maintained, calibrated, and validated condition. Solutions can range from small procedural changes to system redesign/revalidation. CAPAs are put in place for regulatory compliance but also reliable and profitable operations.

Who is the right team to investigate, document, solve, and resolve the issue?

 

Equipment CAPA for Manufacturing malfunction

CAPA investigation:  Who? What? Where? When? and Why?

The parameters of a CAPA problem need to be correctly defined. Each CAPA investigation can be unique since there can be a single or several different root causes.  Often a team is required with different areas of expertise to bring up all possible scenarios.

Areas of investigation can include:

    • Equipment evaluation: For example, verifying vendor utilities as specified versus what was installed.
    • Software evaluation: Code check if the proper alarms were programmed and work properly.
    • Equipment comparison. For example, do similar pieces of equipment have the same problem? If not, what is the difference? These differences could be in process parameters, design, etc.
    • Test runs: Physically test potential change controls before implementing (e.g., ramp rates, alarm settings, and proposed software changes) and return to the currently validated state.
    • Operations evaluation: For example, does the event occur on a specific shift/operator time, times of the year, during other operation events, or only for certain product sizes?
    • Interviews: Personnel such as Operators, Mechanics, and Supervisors may have knowledge that the area engineers don’t have. Use them; they appreciate the acknowledgment of their operations knowledge.
    • Prior CAPA investigations: Sometimes, similar CAPAs for systems and equipment have occurred in the past outside of the effectiveness monitoring period.  Information from these CAPAs will help to avoid the same mistakes, or even provide a forgotten solution.

CAPA Mitigation:  How to minimize risk while work is progressing?

CAPAs take time to solve.  A good risk assessment will help mitigate risks while the CAPA work proceeds.

Examples of mitigations can include:

    • Operations Changes: For example, a reverse osmosis (RO) water system trips from low flow on Monday mornings.  The short-term mitigation would be staggering cleaning systems’ use of RO until the situation was remediated.  Another example is switching problematic processes to another line that doesn’t have that problem.
    • Awareness Training: For the RO system example, operators and supervisors would be made aware of the situation so they could check usage before starting their work.
    • Documentation: Document all events after CAPA has started to help see if additional causes exist and if mitigations are helping.

CAPA Activities & Documentation:

CAPA investigations generate a probable list of root causes.  Each root cause will have its own activities and documentation.

Types of CAPA activities and the documentation required:

    • Correction: Example – Replace a failed sensor or equipment component.  Documentation includes the basic maintenance work order.
    • Corrective Action: Example – Change calibration or maintenance schedules due to reliability. Documentation includes SOP changes.
    • Preventative Action: For example, repair PLC control code to mitigate missing alarms or proper pump priming.  This example would be a weekend software validation change control.
Get CAPA help from PSC Consultants

CAPA Effectiveness Monitoring / Closure:

After CAPA activities are completed, there will be a period of Effectiveness Monitoring before CAPA closure.  If effectiveness monitoring fails, the CAPA will revert to the investigation phase. Successfully closing a CAPA will result in greater equipment uptime and remediate regulatory compliance issues.

PSC Biotech has experienced and efficient CAPA investigation and support services.

If you need CAPA Investigation and technical support service, contact PSC Biotech®. Our professional services group has the right technical expertise to ask the right questions and help solve your CAPA problem in a timely manner.

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Expert review

Identifying the Inspection Room Answer Team

How does a company or site determine not only the disciplines required to be “on call” for possible inspection support? Specifically, who are the SMEs to ask? Waiting until after an FDA Investigator has asked a technical question is the wrong time to start discussing who onsite may know the answer. Worse yet is having the Investigator wait for a surprised and unprepared person, who is hopefully an actual SME on the question at hand, to provide ad hoc answers to Investigators.

The recommendation is that SMEs are identified in advance and prepared for the role they may have to fill on a Site Inspection Team. This designation and role need not be formalized by job title but should be captured, maintained, and updated in some form of record accessible to Site Agents when/if needed. Below is only one example of a straightforward (and incomplete) format for such an internal plant SME list:

Subject Matter Expert contact chart

The type and amount of information in such lists is up to users. The fundamental aim is to quickly and accurately identify whom to refer a question and how to get in contact with them.

Which SMEs Are Needed?

Trying to determine everyone who may need to provide information in an inspection requires a bit of fortune-telling. However, site management is usually aware of past and present “hot topics” based on the nature of the site’s operations, regulatory history, etc. At a minimum, the following disciplines should be required to identify appropriate SMEs for inspection support:

    • QA/QC/Validation
    • Engineering/Maintenance/Calibration
    • Process Support/Technical Operations
    • Regulatory Affairs
    • Manufacturing/Operations

Preparation and training of the selected individuals should follow management approval of the SME list, as they are an essential part of your Inspection Management Team. Watch for future blogs on those topics!

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What is Inspection Management Software (IMS)?

Inspection Management Software (IMS) is the alternative to using a combination of video calls, spreadsheets, logs, record systems, document generation software, and online document sharing platforms. Efficiency for fulfilling inspector’s requests is immensely improved by using a single software system to log, track, generate, and produce reports.

History of Inspection Management Software

AuditUtopia® was the first inspection management software created in 2009 by PSC Software™. AuditUtopia® is an out-of-the-box solution for effective, streamlined management for inspection events. It is the highest-rated audit software product compared to similar products on Capterra.

AuditUtopia® supports your company by providing a single platform to:

    • Track and manage inspections
    • Log inspection and scribe notes
    • Enter and track requests
    • Send notifications
    • Real-time team communication
    • Configurable permissions
    • Generate charts and graphs
    • Export reports
AuditUtopia

 “Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia® has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia® and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”
– Former Food and Drug Administration Commander

The Evolution of IMS – Beyond the Audit Room

After the fastest vaccine generation and rollout in US history, the need for agile management of pharmaceutical and biotechnology regulatory affairs is greater than ever. PSC Software™ is announcing the new inspection management system essential – ACE Inspection®. This new addition to the Adaptive Compliance Engine (ACE™) extends compliance inspection and audit management beyond the investigation day. ACE™ is an electronic quality management system (eQMS) for end-to-end quality and validation management. Enhance your audit readiness by integrating your day-to-day quality management processes with your inspection management software. On top of AuditUtopia®’s features, ACE Inspection® adds:

  • Pre-validated installation and operational qualification (IQ/OQ)
  • FDA-mandated 21 CFR Part 11 compliant electronic signatures
  • Application Programming Interface (API) to integrate other software or cloud documents
  • Single Sign-On (SSO) support
  • Interactive charts on the dashboard
  • Enhanced chat and scribe
  • Scribe record tagging, which integrates into ACE™
  • In-system notifications
  • Coordinates with ACE SuperVision™ for Google Glass Enterprise 2.0
  • Form Auto-Fill
  • Workflows for multiple inspection types (e.g., FDA vs. EHS inspections)
  • Configurable workflows for each record type (e.g., Inspections, Requests, SME Interviews)
  • Multiple report templates that pull metadata from the system (e.g., Audit, Management and Inspection Summary reports)
  • Event management (due dates, scheduling, reminders)
  • Audit resolution and CAPA follow-up

In Summary

Choose AuditUtopia® if you want a pre-configured inspection management software to use during audits. Leveraging industry-leading features that allow teams to take scribe notes, manage requests, and create reports, AuditUtopia® streamlines inspection events. It is an unmatched economical approach to comprehensive inspection management. To extend your accuracy and preparations, choose ACE Inspection® because it encompasses processes beyond inspection day events. ACE Inspection® brings you broader capabilities with configurable workflows that allow teams to track and manage daily summary notes, near misses, and observations. PSC Software™ gives you the choice of inspection management software solutions.

For a free demonstration or more information on industry-leading Inspection Management Systems, visit pscsoftware.com or contact PSC Software™ at sales@pscsoftware.com.

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Site inspections are regular activities to check and verify your organization’s regulatory compliance, safety standards, and more. The FDA, EHS, and the EPA may do inspections and audits virtually or in the field. The FDA tries to inspect each licensed firm every two years or less. To successfully navigate inspections, you should have a dedicated Inspection Team. The purpose of this team is to conduct mock inspections, manage the inspection process, and ensure the readiness of the site, staff, and documents.

To address the breadth of compliance inspections, several different areas of expertise and people from various departments should participate on the Inspection Team. First, make a well-defined role and set of responsibilities for each person. Training and testing each Inspection Team member on their responsibilities reduces the risk of errors and improves confidence. 

Teamwork for inspections and audits

Members of the Inspection Team include:

    • Inspection Leader
    • Inspection Room Leader
    • Subject Matter Experts
    • Scribes
    • Hosts
    • Document Request Coordinator
    • Document Runners
    • Administrative Personnel

How to Choose Your Team

Key characteristics include performing well under pressure, ease in answering questions, and answer concisely, confidently, and intelligently. The members need to be well-versed in the Standard Operating Procedures (SOPs). This entails knowing the content, purpose, and how and when to use the SOPs. A document manager for audits, such as ACE Inspection, could improve your efficiency and success in meeting Inspector requests. The Inspection Team should comprise of representatives from:

    • Quality Assurance
    • Regulatory Affairs
    • Manufacturing
    • Quality Control
    • Material Management
    • Scientists and Technical Manufacturing Experts

The Purpose of the Inspection Team

The Inspection Team will also develop the documents and review SOPs beforehand. To prepare for an inquiry, you also need to go through a mock inspection, which the Inspection Team can perform. This simulates the stress of the actual process, assesses gaps in knowledge, prepares responses, points out inefficient methods, and builds confidence. With good preparation, you can focus on making an excellent first impression. 

Consultants

Consultants are helpful for gap analysis, identifying risks, and even prepare a readiness plan for your Inspection Team. Furthermore, consultants can help you write responses and follow-up reports after an inspection. Great consultants can work within your budget and your needs through services tailored just for you. 

PSC Biotech and PSC Software offer solutions for inspection day preparation and management. For more information on our consulting expertise, contact info@biotech.com, and for ACE Inspection software, email info@pscsoftware.com. 

ACE SuperVision™ for Google Glass Enterprise 2.0

ACE SuperVision™ for Google Glass Enterprise 2.0

PSC™ has recently taken the software you know and love, ACE™, and integrated it with Google Glass Enterprise! ACE SuperVision™ allows companies like yours to put safety first while streamlining your workflow processes. Together, you will have the same capabilities you’re used to in a new and innovative form! With ACE SuperVision™ on Google Glass, employees can integrate instructions and outcomes in real-time. Employees are free from bulky clipboards, phones, and tablets for faster and safer work. Additionally, Google Glass provides another layer of protection by meeting safety goggle standards. Now your company can be more efficient while being safer than ever!

What is it?​

ACE SuperVision™ is an application from PSC Software™ that integrates wearable technology devices with PSC™’s Electronic Quality Management System, ACE™. With this system, requests can be sent to the user’s device to be filled. Also, ACE SuperVision™ syncs Google Glass documentation to your ACE™ database. ​​

Why we need it?​

Before COVID-19, industry trends showed a growing interest in hosting inspections and audits in remote settings. During COVID-19, PSC Software™ anticipated the urgency to develop a solution for remote inspections and audits. We want to expedite bringing products to market and improving the quality of life for patients.​

Who will use it?​

Any industry that hosts audits and inspections will capitalize from using ACE SuperVision™ on wearable devices. ACE SuperVision™ has numerous features, including Speech to Text, Audio Recording, Video Recording, Taking Photo Images, Scanning QR Codes, Video calls, Text Instruction, and more. For example, you can host audits and inspections virtually, view instructions from your glasses, and operate equipment safely with both hands! 

ACE SuperVision for Google Glass

Current Problems

  • Restrictions for personal interaction due to COVID-19 have created delays in regulatory and supplier auditing.
  • Some industrial environments require a lot of hands-on activities and handheld devices.
  • Users might need to utilize other devices to browse instructions frequently.

Our Solution – ACE SuperVision™

  • ACE SuperVision™ supports virtual Video calls such as Zoom and Jitsi.
  • Both parties can progress in audit activities via a remote environment.
  • An operator, calibration technician, or QC Analyst can conduct activities hands-free, improving productivity and safety.
  • Provide predefined request instructions on the screen of the wearable device for easy follow-up.

PSC™’s newest software, ACE SuperVision™, is at the forefront of efficacy solutions in the pharmaceutical and medical devices industries. We created software for rapid and agile data gathering, equipment management, workflow mastery, audits, and more. Be on the cutting edge with wearable devices and enhance your capabilities!

If you are interested in our adaptive compliance engine, ACE™ go to PSC Software™. Furthermore, contact Emily Lee for information and Ryan Ciarcia for purchasing! In addition, enhance your progress with our professional services at PSC Biotech™.

The Importance of First Impressions on Inspection Day

The Importance of First Impressions on Inspection Day

What are you and your team doing to win on inspection day? Preparation for inspections is an ongoing process. You likely have a lengthy checklist of items that must go perfectly on the day of an inspection. However, many inspection readiness teams overlook the importance of first impressions. According to FDA inspectors, a positive first impression can result in quicker and smoother inspections. So, how do you prepare your team to make a great first impression?

Whether your team makes a great first impression is determined long before the inspector arrives. For instance, are the greeters well trained and prepared for inspection day? Greeters should welcome the inspector, take the inspector to your inspection room, and alert the team of the inspector’s arrival. If the inspector visited your organization in the past, a representative acquainted with the inspector should lead the opening meeting.

Greeting

During the opening meeting, the team should keep to a time-appropriate script. Give an introduction, go over the scope and schedule, provide the inspector directions to the restroom, and discuss lunch plans. Being a gracious host should be number one on your inspection day checklist. One simple thing you can do to show respect is to ask if the inspector has any dietary restrictions and go through your scripted introduction. Considerate hosts appear more experienced and prepared, which can influence the outcome of an inspection. Suppose the inspector is unfamiliar with your operations. In that case, they may request a brief tour of the facility after settling into the inspection room.

Inspectors frequently arrive unannounced, and sections of the facility may be cluttered due to everyday work activity. At the beginning of the tour, the guide should lead inspectors through the cleanest areas of the building. Inspectors often associate a clean work environment with a cGMP compliant organization. Additionally, ensure that all employees are following your written and approved gowning procedures. As they are guided through the facility, inspectors watch for inconsistencies; so, personnel attire must be consistent and by the book. Practice giving the tour to your own staff “inspectors” to ensure your team is prepared for inspection day.

Furthermore, there are several common requests that the inspector will always make at the start of an inspection. These requests are often referred to as “pre-requests”. They can include the index for SOPs, maps of the facility, product flows for the facility, SOPs on training, etc. Quickly delivering the documents that are commonly requested at the onset of an inspection will give the inspector the impression that your facility and quality management system operate in a “State of Control.”

Inspector in protective uniform with hairnet and mask taking parameters from industrial machine in a lab

Inspection readiness is crucial to the success of organizations in highly regulated industries. In many cases, a favorable first impression is merely a great start but not enough to win on inspection day. However, implementing an Inspection Management System such as AuditUtopia® or ACE Inspection® can streamline your inspection processes. PSC’s Inspection Management Systems allow your team to take scribe notes, manage requests, collaborate on requests, and report on inspection data, all within a unified and secure platform. To help prepare documents and your team for inspection day, consider our consulting services at PSC Biotech.

For a free demonstration or more information on industry-leading Inspection Management Systems, visit pscsoftware.com or contact PSC Software™ at sales@pscsoftware.com.