Wrapping Up the Inspection

Wrapping Up the Inspection

This series on inspection success has stressed the importance of making a good first impression,  preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests.  We conclude the series with a discussion about what to do at the end of each day of an inspection.

You want to do a wrap-up meeting at the end of each inspection day.  The inspector usually covers what they examined today, presents what they found, and briefly describes the most critical findings found today.  The inspector or investigator will usually NOT cover all findings.  You will need to check the complete audit report.

If this is a multi-day audit, the inspector may give you a list of documents, specific items, or areas that they want to see when they return the following day.

Inspection

When the audit is over, you will have a final wrap-up meeting.  If the inspection is an FDA inspection, the inspector will present a Form 483 listing their findings listed in order from most to least important.  If it is not an FDA audit, the inspector will usually do the same thing, minus the Form 483.  Listen to the inspector.  Ask questions to clarify anything you are unsure of.  Do not argue. Be polite.  Say thank you.  The inspector may give you their preliminary conclusion if you do or do not operate in a “State of Control”. Do not argue. The inspector will tell you how the final audit report will come to you, when you can expect to receive it, and how to respond to the audit report.

Thank the inspector. Walk the inspector out and bid them a pleasant evening. Always be polite to your inspector.

When it is all over and the inspector is gone, go through the 483 or the audit report.  Your audit response will respond to absolutely everything.  Quote each finding, write down your response, and attach evidence for everything.  Cover every single point. If the inspector wants evidence for green, blue, and yellow valves, provide one attachment for each color valve. They want evidence to prove that you did what you say you did.

PSC® can help you achieve success on every audit.  Consult with our experts. We have over 25 years of experience with audits, audit preparation, mock audits, and compliance gap analysis.  Consider using PSC’s AuditUtopia® and ACE Inspection™ audit management software to automate and simplify your audit process.  PSC® is your one-stop solution for audit and inspection success.

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

A Deviation has Occurred - CAPA

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are carefully thought out to minimize any critical errors that could compromise the product. Therefore, there must be an investigation when a product step is missed or a deviation occurs. The investigation needs to assess what happened, why it happened, and how to prevent this error from happening again. Here we give you an overview of the proper process after a deviation has occurred. 

There could be several factors that can cause a deviation to occur. For example, there might be a new hire who is not familiar with the process, or the manufacturing crew may be rushed in completing a batch. Other potential factors include: distractions in the room, the wrong material was added, or the equipment being used may have an expired calibration. Suppose a member of the manufacturing team used a piece of equipment on which the calibration was overdue. During an in-process check by a member of QA, they spotted the calibration on the equipment had expired. This is when the deviation process begins.

There are several steps when talking about the deviation process. The purpose of the deviation is to identify, investigate and close. Also, remember that the amount of time to complete a deviation from beginning to close is very important and should be specified in your deviation Standard Operating Protocol (SOP). Here are the three principles for the deviation process:

    • Identify the error – Notify the appropriate management/personnel and fill out the required form that describes what exactly happened to cause the deviation.
    • Investigate what happened – Talk to the personnel involved, review any videos in the room, review any paperwork inside the room, and look at how this piece of equipment’s calibration was missed. This part of the process is basically to understand why this deviation occurred.
    • Closing of a deviation – Occurs is when the investigation is complete. We now know exactly what happened. Closing of the deviation consists of correcting the error. In this example case, get the equipment checked out to make sure that it is within specification. The other part is putting in place a check to ensure that this doesn’t continue to occur. Once these items are in place, the deviation can be closed.

The entire company needs to be on the lookout for anything that may cause a deviation. You must have checks and double-checks because we are all capable of missing something. What it all comes down to is deviations will happen, but how you handle them and learn from them is what matters to make your company the best it can be.

For more information in the field of Corrective and Preventative Actions (CAPAs), see our blog on CAPAs for Equipment.

PSC Biotech® has engineers and professionals to help you through the deviation process and establishing CAPA procedures. Contact us now to find out more!

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Creating a Validation Master Plan (VMP) is a guide for successful validation and qualification throughout a facility.

To ensure that a specific piece of equipment or process gives the output desired, the equipment used for the product must be validated. Equipment used for testing or manufacturing must be validated due to the risk it may propose to the product or end-user. Not validating equipment currently used for testing, V&V, manufacturing, and inspection purposes will likely result in a major audit finding, such as an FDA Form 483. The Validation Master Plan is the manufacturer’s roadmap for qualification throughout a facility. It clearly defines the systems which must be validated and details the program the organization sets forth to conduct validation activities.

Validation master plan

Effective process validation contributes substantially to assuring a quality product. The basic principle of quality assurance is that a product shall be made to fit its intended use. If there aren’t any controls for validated equipment, then all results and finished goods have no assurance of consistent outcomes. If something ever goes wrong with a product, it would be hard to identify the root cause of the issue if the equipment used for the process does not have proof that it is working as it should and that the outcome of its performance meets the design controls for the product.

The Function of a Validation Master Plan (VMP)

The Validation Master Plan (VMP) is beneficial for planning purposes because it identifies anticipated resource needs and provides key input into scheduling project timelines. It documents the scope of the validation effort, including impacted products, processes, procedures, facilities, equipment, and utilities.

The VMP also includes a schedule that creates specific timetables for when each validation will take place and by whom. The Quality Department, which controls validation activities, defines the impacted functional areas in the document suitably.

Like other master plans, the VMP is a tool for process control. It serves a practical function in instructing personnel on how and why validation activities should be carried out. Furthermore, it serves as a compliance function since it documents the validation program, as required by regulatory agencies for proper process control.

Additionally, the VMP enables stakeholders within the organization to unify around the details of the validation strategy. It eliminates the ambiguity in justifying validation activities, internally within teams and externally for inspectors and auditors. Beyond the frontline, it can be a vital tool for informing and educating upper managers about the importance of validation in terms of its downstream impact on product quality.

A well-crafted Validation Master Plan can be a primary resource in scoping a validation effort to determine impacted products, processes, procedures, facilities, equipment, and utility systems. PSC Biotech® offers outstanding quality assurance services that help a company be ready for an audit. Contact us now for more information about PSC Biotech® consultants for VMPs.

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

Inspection Room - Fulfilling the Investigator requests

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting together a preparedness inspection management team. Also, we went over basic and advanced options for inspection management software to stay organized and expedite the inspection process. In the last inspection series installment, we initiated the discussion on who to have available during an inspection. In this blog, we’re taking it one step further and into the crux of the matter – fulfilling the inspector or investigator’s requests.

Inspection Day

You’ve created a room for the inspector to do their work, the audit room. With the inspector are the host and at least one scribe. The scribe is writing down everything the inspector says, and these notes are relayed to the backroom. The backroom can contain several people, as many as needed to expedite the process.

The goal is to fulfill an inspector’s request in 15 minutes or less.

Inspector Requests

The three main request types are paper records, electronic records, and asking to speak to someone. Keep a record of all documents, files, drawings, etc., that are being provided.

Paper requests

Requests for paper documents or records are relatively simple –

    • Make sure the document is complete and doesn’t have any yellow stickies on it.
    • Figure out who is the best person to talk about the record, if so needed.
    • Bring the document to whoever is going to present it to the inspector.
    • Give it to the inspector, and then they will give it back when they’re done.

Electronic requests

An electronic record request is similar in structure to the paper record, but simpler. These kinds of requests are fast and easy with inspection management software. The primary components for electronic record and document requests are:

    • Review the electronic record or document in the backroom.
    • Send it to the investigator.

Interview requests

The final type of request is a bit more involved. The regulatory affairs inspector or investigator might request to talk to someone in the company. For example, they might want to interview someone from quality control specializing in chemistry or microbiology. Have your Subject Matter Expert (SME) come into the room with the inspector. Then the SME will undergo a series of questioning as if they are on the stand in a courtroom. The SME should:

    1. Listen to the investigator and what they want carefully. Every time the investigator asks a question with two components, the SME should clarify first with, ‘which question do you want me to answer?’, and then wait for the answer.
    2. Answer the question as if in a court of law because this is, more or less, the same thing.
    3. Only respond with ‘yes’ or ‘no’ or the most concise and brief answer to the question – without elaborating or going off-topic.
    4. Then immediately discontinue speaking and wait patiently.

Summary

There’s nothing better than practice. Practice inspections, practice retrieving and presenting, practice showing documents virtually, have the SMEs practice by grilling them and giving feedback. PSC Biotech® provides experienced professionals to help you prepare for and practice inspections. Contact us for more information!

Remember – be polite, listen to the question, and think before responding.

We have several more tips for you in our subsequent installments of the inspection series – frequently asked questions, how to wrap up an inspection, and our recommendations for your receptionist’s red book. Follow our blog by email or social media for more insights from our former FDA inspectors, engineers, and exceptionally experienced professionals! 

Join Our Newsletter

 

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

How to Find the Perfect Consultant

How to Find the Perfect Consultant

After an hour-long meeting of highly caffeinated conversations, the executive leadership team woke up this morning creating an Excel list of action items that topped off your inbox. The dreams of last night turned into the demands of the workday today. This Excel list presents yet another opportunity to execute a hefty workload. “Work smarter, not harder” is the famous quote of Allen F. Morgenstern coined in the 1930s. Is this quote just another business cliché epitomizing the corporate dynamic, or is there an underlying truth below the consciousness of strategy?

Consultants provide a unique strategy to execute those demanding lists. Think of it like a horse race; all the horses are saddled up, ready to go, waiting for the signal to be released. A consultant is a person who provides subject matter expert advice professionally. They have a unique skill set that is targeted toward a specified field. Picking the perfect consultant doesn’t have to be a daunting task; it can be fun provided you follow this guide. After reading this, all that is needed is the signal to start the race! Look at some simple steps that will surely have the champion at the finish line.

PSC Consultant

11 Steps to find the perfect consultant:

    1. Identify – The first step to success is identifying when and where help is needed. Some of the most successful organizations in the world have mapped out the areas of their organizations where they need expertise and guidance. It is imperative to know where the strengths and weaknesses exist. Moreover, it is crucial that subject matter experts are assigned to those areas.
    2. Document – Organize and compose a project charter. A project charter outlines the scope, objectives, timelines, and participation of the project. Identifying the key stakeholders, team leaders, and participants of the project is key.
    3. Communicate – Communicate with your team to gather insight into the project and alignment on the project charter before sharing it with an outsider!
    4. Connect – Connect within your professional network to identify trustworthy sources. Often our colleagues or former colleagues are the optimal means to find out exactly what we are looking for. Word of mouth is a great form of advertisement. That is why most organizations have those surveys after each experience. How likely are you to refer company XYZ?
    5. Research – A little research never hurts anyone. Digging into the schematics of a potential organization will help guide your project charter into completion. Who has the company worked with in the past? Are they reputable? Check to see if they are registered with the better business bureau. Also, are they accredited? Does the company hold any specialized certifications? What is their reputation like?
    6. Choice – Make one! Compose a list identifying your top 3 choices.
    7. Interview – Once the perfect companies have been identified, interview with them and document the pros and cons of each.
    8. Collaboration – involve your team and collaborate with them on your findings. Introducing your discoveries and cohesively coming into an agreement on what skillsets are offered would be the best to execute the project charter.
    9. Approval – Obtain approval from the Executive Leadership Team. Bring coffee and gifts if needed!
    10. Documentation – Document project terms and conditions. Getting that signature sign-off is crucial to commence the project.
    11. Breathe! The horses are running, and the champion will soon have the crowd cheering!

Finding the perfect consultant starts with PSC Biotech Professional Services. We have been consulting and providing professional services for over 25 years. We have educated experts who are ready to complete those projects! Contact us for more information at info@biotech.com.

by Candice Harris

Join Our Newsletter

 

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

Inspection Management Teams for GxP Inspections

Inspection Management Teams for GxP Inspections

Undergoing a GxP-compliance regulatory inspection is a challenge for any company or site staff. Since various individuals, and even multiple departments, participate in inspections, you need a high level of pre-inspection organization and planning. In previous blogs, we discussed how Inspection Management Software (IMS) tools like PSC’s AuditUtopia® can assist in providing organization and tracking of requests and documents during such an inspection. But who provides the answers to the Investigator’s technical questions? Time to introduce your Subject Matter Experts (SMEs).

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!

Join Our Newsletter

 

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Related Articles

A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

The Importance of Validation

The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

Stay In the Loop - Join Our Newsletter