From a regulatory and compliance perspective, effective product complaints management is not just a good practice; it’s a necessity. Immediate, real-time responses to urgent customer requests and returns are paramount in an industry where product failure can have life-altering consequences for consumers and legal ramifications for manufacturers. The call for a single, uniform, and secure platform to handle product complaints from initiation through to closure has never been more urgent.

While some pharmaceutical companies might see complaint management as a detached process, it is, in fact, an integral part of consumer management. A well-executed complaints management program goes beyond meeting regulatory requirements; it can significantly decrease customer maintenance costs, boost revenues, and enhance a company’s ability to track historical customer and product trends. This valuable data, in turn, becomes instrumental in forecasting future market, product, and customer needs.

In the complex realm of pharma, achieving effective complaints management is no small feat. The difficulty doesn’t only lie in addressing customer concerns promptly but also in navigating the intricate landscape of government regulations. However, the benefits of effective complaints management are far-reaching and go beyond mere compliance. Let’s delve into why it’s a game-changer for pharmaceutical companies.

The Process

The pharmaceutical complaints management process is a systematic approach designed to address and resolve issues raised by customers regarding pharmaceutical products. While the specifics may vary among companies, a well-formed complaints management process typically includes the following key steps:

1. Receiving Complaints:
   1. Channels of Communication: Complaints can be received through various channels such as customer service hotlines, email, online forms, or even social media platforms. These are then routed to specific teams (either pharmacovigilance or product complaints).
   2. Documentation: Regardless of the process, each complaint is documented thoroughly, capturing essential details such as the nature of the issue, product details, and contact information of the complainant.
2. Initial Assessment:
   1. Categorization: Complaints are categorized based on severity and type to prioritize responses. This step helps in determining the appropriate level of urgency and attention required. Examples include if there is a Three Day Field Alert (3DFA), where a patient alleges a potential contamination or missing lot number, or leveling the product complaint (1, 2, or 3).
3. Investigation:
   1. Root Cause Analysis: A thorough investigation is conducted to identify the root cause of the complaint. This may involve collaboration between different departments, including quality control, production, and research and development.
   2. Product Evaluation: The implicated product is often examined to assess its compliance with quality standards and specifications.
4. Response and Resolution:
   1. Customer Communication: The customer is informed about the progress of the investigation and provided with a clear timeline for resolution.
   2. Corrective and Preventive Actions (CAPAs): Based on the findings, corrective actions are implemented to address the immediate issue, and preventive measures are devised to avoid similar problems in the future.
5. Documentation and Reporting:
   1. Record Keeping: Every step of the complaints management process is documented for regulatory compliance and internal analysis.
   2. Regulatory Reporting: If required, reports are submitted to regulatory authorities in accordance with their guidelines.
6. Follow-Up:
   1. Customer Follow-Up: After resolution, companies often follow up with customers to ensure their satisfaction and gather feedback on the effectiveness of the implemented solutions.
   2. Continuous Improvement: Lessons learned from the complaints are used to enhance product quality, manufacturing processes, and overall customer experience.
7. Trend Analysis:
   1. Data Analysis: Aggregated data from complaints is analyzed to identify trends and patterns that can inform strategic decision-making and continuous improvement efforts.
   2. Feedback Loop: Insights gained from complaints are often fed back into the research and development process to improve future product iterations.
8. Training and Communication:
   1. Employee Training: Employees involved in the complaints management process receive ongoing training to stay updated on regulations, company policies, and best practices.
   2. Communication: Internal communication ensures that relevant departments are aware of the outcomes of the complaints management process and can implement necessary changes.

Example of Complaint Management in Action By following this comprehensive process, pharmaceutical companies aim to not only meet regulatory requirements but also continuously improve their products and services based on customer feedback. The below flow chart is an example of how this process may look at an organization…

In this diagram, note that complaints have been broken into two workflows: adverse effects (AEs), which are routed to a designated pharmacovigilance team, and product complaints (PCs), which are routed to a special complaints team. Additionally, for product complaints, some companies may design a ranking system for each complaint to determine next steps for investigation.

For example, a Level 1 complaint may have no SISPQ (safety, identity, strength, purity, and quality) impact, such as an aesthetic design issue, and require no further investigation. However, a complaint around usability of the product, potential contamination, or a Three-Day Field Alert (3DFA), would be tagged as Level 2 or Level 3 and would require further investigation by the company’s quality infrastructure. It is important to note here that some companies segment their processes like the flowchart above, while others may bundle all complaints together.

Whatever the case may be for your company, the starting point should be the same: always consult current regulations and expectations related to your product (FDA, EU, Japan, etc.) and use them to build your process. Also, continually auditing your process is essential to maintaining control and compliance!

How Can Process Alliance Help? So, why is having a robust complaint process a value to your patients and business? Beyond a cGMP requirement, a well-structured complaints process represents a commitment to both your patients and your business to provide consistent, safe, and effective regulatory approved marketed product by monitoring adverse events and product complaints. By monitoring adverse events and product complaints, you provide a regulatory agency with objective evidence that your manufacturing process is under control. Additionally, it opens an avenue for your patients to communicate and establish a healthy relationship with your company by listening to their feedback. Here are just a few ways that our experts at Process Alliance can offer support…

• Audit your current product process, provide suggestions for process improvements, and create opportunities for more time and resources.
• Assist in triaging/prioritizing product complaints due to a backlog—and help to lessen (or even eliminate) it.
• Assist in the development of a robust process that deeply investigates and provides solutions for product complaints.

Ready to Optimize Complaint Management? Process Alliance is a pharmaceutical engineering consulting company committed to providing high quality results for our clients that are expanding or have been asked to update their internal processes by their customers.

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Even after 28 years, when asked where a sample or reference material to make a new set of controls and standards is, I still get a chill up my spine—and a fight or flight response—because what if we can’t find it? Honestly, it is bad enough when one of your lab mates comes up and asks. So when a client or the FDA asks for the audit log, and asks to be taken to the location, it is downright terrifying.

Transitioning a Process Can Be Hard

One thing I really enjoyed about working in small labs is (mostly) everything can be managed with paper and Excel. Unfortunately, many labs hold out too long before moving to a more advanced electronic solution because of the initial investment. When you start out looking at an all-inclusive system, you are looking at spending over $100,000. The next best option is spending time to build a COT system. Once the decision is made you must bring the system online and train everyone—and I do mean everyone—on the use of the new software and the importance of it. Inventory your storage units, import the data, re-inventory everything using the new reports, make corrections, and then finally go live.

After 3 months, even if it looks great, you should go back and check to run an inventory list of each storage unit and make sure you really have what you think you have. Unfortunately, I know from personal experience that it will not be correct, and it happens because of good intentions. Here are some common dialogues:

• “The lab never used to require you to log into the inventory of all samples generated in the lab. Why should the scientist not just place the samples in the controlled inventory freezer?”
• “I just needed to get a reference sample to make the stability samples and I did not have time to make the request, so I asked someone from management to unlock the freezer for me. Then did not document in my notebook where the material came from or remove it from the LIMS software.”
• “Our client needed samples shipped ASAP, so we went into the freezer and physically removed them and forgot to document the removal.”
• “There was a power outage and instead of calling the inventory management group we just moved everything out of the storage room and moved them to other storage units throughout the lab.” This one caused me to lose a few racks of samples for about a week.
• “Sample management moved the samples to my freezer. I don’t have to document them moving to my work bench. I only throw out tubes when there is no sample left.”
• “I just documented that freezer number because I knew it was the correct temperature the samples should be at. I did not notice the actual freezer number.”

In Sample Management, Compliance is Key The sad truth of sample management is that even with a nearly perfect electronic system that is easy to use, user compliance is everything and humans tend to find ways to make a mess of things. I was working in a high-throughput laboratory where individuals were running thousands of samples a week. They had the ability to scan a box of samples from sample management storage to their freezer shelf to their benchtop and back. Easy peasy—and the LIMS system would keep the chain of custody! The only problem was that people kept forgetting the scanning process, samples got lost, and the chain of custody was broken. Thankfully, most of the samples were found. But to mitigate the missed scanning, a paper form was generated. At each step, not only did the samples get scanned to a new location, two people had to sign off that it happened. It is a horribly inefficient method to correct these types of errors, but management did not want to disrupt the analysts’ work process and enforce the proper use of the electronic system.

Process Flexibility is Determined by You

If you are not going to enforce the proper use of your electronic chain of custody, you must create a paper chain of custody and then ensure that QC and QA are regularly confirming the use and compliance. Then to make the sample management group’s life more difficult, they must regularly reconcile all samples in their care manually until compliance is once more obtained. I recommend using the AQL system to determine the number of racks and boxes you must check.

There are many times that when a laboratory has not complied with the processes for too long, you end up needing to tighten the process so that it is so inflexible that the individuals must comply, or they do not get their samples to work. No one wants this—but when dealing with controlled samples, chain of custody is paramount. The last thing you want is the client or the FDA to request a sample disposition and you give them the freezer shelf and box ID—only for them to go to the freezer farm and find that it is not there.

Need Sample Management Support?

Do you find yourself in a position where your company needs help with sample management or LIMS? Process Alliance has the experience and expertise to provide you with the support you need—from implementation, to remedial corrections, to process vs. practice studies.

The post Are You Keeping Track of Your Sample and Reference Material? appeared first on Process Alliance LLC.

In short, process failures are prioritized according to how serious their consequences are, how frequently they occur, and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce the impact of failures—starting with the highest-priority ones. Let’s piece apart the components of FMEAs, and explore how they can be used to enhance your processes…

FMEA Components

FMEA is used during design to prevent failures. Later it is used for control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.

There are many critical components of FMEA. Let’s look at a few definitions:

• Failure mode – this is the way (or ways) that a process can break down.
• Cause of failure – this is the tangible reason for the failure
• Potential effect – this is the consequence of the failure on the rest of process or product
• Risk Priority Number (RPN) – this is determined by multiplying Severity, Occurrence and Detection rankings (see example below)
• Probability of harm – likelihood harm to equipment or personnel will occur based on Detection and Occurrence rankings
• Severity of risk – risk determined by probability of harm and Severity ranking
• Action – task assigned to reduce risk associated with failure mode by decreasing severity or occurrence or increasing detectability
• After-action review – an assessment of risk after actions are put into place Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement.

The Process

An FMEA can have different foci, depending on when the analysis is performed in the process lifecycle. Design FMEAs are centered on determining causes of failures during the design phase of process implementation so the design can mitigate potential failures from startup. When a process is already running, an FMEA can be used to determine the cause for ongoing and recurring failures on the associated equipment and improve risk management by identifying gaps in preventative maintenance programs or failure detection measures.

Regardless of when an FMEA is completed, it should be a collaborative effort between every function that touches the manufacturing process (e.g., engineering, maintenance, operations).

Once the initial analysis is completed and appropriate actions are completed, the group should reconvene to reevaluate the severity, occurrence and/or detectability of each failure mode. Each FMEA is intended to be a living document that is reviewed or revised on a periodic basis or at least following any major project on a component of the system. This ensures that the potential risk associated with each failure mode is accurately portrayed and new risks are identified as the system changes throughout its lifecycle.

Example FMEA for a Water Storage Tank

As shown below, the overall performance of a water storage tank can be investigated using FMEA. Listed in the first column are components of the tank, such as water hold tank, valves, centrifugal pumps, and nozzles. The next column outlines the potential failure modes, and their potential effects, and probability of harm.

Severity, Occurrence and Detection numbers are entered by the analyst, as well as descriptors for causes of failures, and current controls in place. The criteria for determining these rankings is below:

These rankings can then be used to calculate the RPN so that recommended actions can be prioritized. Additionally, the probability of harm can be determined by assessing values according to the matrix below:

Actions, responsibilities, and timing for completion are all critical components of a well-structured FMEA. It is from these actions that a thorough after-action review can take place. It should be noted that not all failure modes require actions, and all proposed actions need not be completed, if the level of assumed risk is accepted by all stakeholders.

The Benefits of FMEA

Our engineering consultants have worked with pharmaceutical manufacturing clients to introduce and apply FMEA to their processes. Here’s what one client had to say:

We partnered with Process Alliance to work on FMEAs for equipment that was not reaching our desired level of uptime which, at times, caused negative impacts to our production schedules. This partnership has identified multiple maintenance, engineering, and automation gaps on nearly every piece of critical production equipment and plant utility equipment that we have assessed. With the help of Process Alliance’s FMEA process, we have been able to update our preventative maintenance routines as well as launch engineering and automation projects to fix both legacy problems and to prevent potential failure modes before they occur. The partnership with Process Alliance has been a successful endeavor to increase the reliability of assets throughout our facility.

PA is a leader in the GxP space for providing high quality results like these for our clients that are expanding or are looking to optimize their processes by integrating FMEA.

The post Mitigating Risk in Your Process via FMEA appeared first on Process Alliance LLC.

At the time, I was working in a new lab and was tasked with procuring a reliable gamma counter at an affordable price (new price > $40,000). Also it needed to be able to connect to an online statistical software. I had a budget of $8,000 to get it all accomplished. In the end, I was able to get the gamma counter delivered, an IQ/OQ/PQ performed, and have it networked for just over $8,000. The unit ran and collected data in a GLP bioanalytical lab with no issues—and great service responses from the vendor. This was the beginning of my love of refurbished laboratory equipment.

The Time Investment is Worth the Reward

Over the years, I have continued to be a strong advocate of purchasing used equipment for new startup labs or existing laboratory expansions. There are many established and trustworthy used equipment vendors now that you can confidently fill a new laboratory for pennies on the dollar. You will not always find the latest models readily available, but you will find the previous one to two generations back available for purchase.

You can and will spend a significant amount of time researching and looking into identifying the best fit for your lab, but the dollar savings make the loss of time worth the effort.

If you’ve been in science awhile, you know that historically, the only used equipment that was available were units that were overused and nearly nonfunctional. However, that is not the norm anymore. If you are willing to put in the time to go out and shop the various vendors, you can purchase an HPLC that five years ago would have cost you $80,000 for less than $10,000 or a $40,000 multimode UV/Vis microplate reader for $5,000—things have changed.

The preowned market has gotten to the point some primary vendors such as Agilent have begun providing preowned systems that come with manufacture warranties.

Going, Going, Gone! The Value of Auctions

About 5 years ago, I started using auctions from pharmaceutical companies either closing or updating locations. These are great opportunities to get quality used equipment. A few observations on these auctions:

First, be sure to not purchase enough equipment for a new lab with equipment you did not even know you needed or wanted. I accidentally found a synthetic DNA generating robot for around $2,000. No, I did not need it, nor did I know how to use it, but I wanted to make sDNA! Luckily, we ended up being able to use it as part of an equipment trade-in and made money off the trade—so I did not get into too much trouble.

Second, make sure you know what you are buying, especially when buying in lot quantities. I accidentally purchased 11 movable lab benches for $300 thinking I was buying a single HPLC bench—I was shocked when 11 units arrived, and I was expecting only one. The good news is I was able to get work benches into more lab space than we had first thought we would be able to.

Thirdly, the people moving the equipment are not always going to be gentle. I purchased a semi-analytic balance, and it arrived in multiple pieces inside of the Tecan robot. Remember to take multiple pictures of the equipment as it comes off the delivery truck and provide them to the vendor ASAP. It might save you money.

Lastly, when buying from an auction that supports a site closure, make sure you are buying functional equipment as they are liquidating all their stored equipment—including pieces that were on their way to the recycler.

Some Vendors I Like

If you are willing to spend some time looking you will be able to save a significant amount of money on equipment. Below are a few of the vendors that I have personally used in the past and have nothing but positive things to say about them….

• GMI Trusted Laboratory Solutions
• American Laboratory Trading
• LabX
• Cambridge Scientific

Looking to Enhance Your Lab Infrastructure?

Process Alliance is a pharmaceutical engineering consulting company committed to providing high quality results for our clients that are expanding or have been asked to update their internal processes by their customers.

The post The Hidden Value of Used Lab Equipment appeared first on Process Alliance LLC.

These are all terms used to identify a situation in a pharmaceutical manufacturing facility where something didn’t go as planned. In the absence of a well-managed, robust process, the numbers of these events can spiral out of control—sometimes, it feels like the numbers double overnight. And when issues start to exceed the capacity of the organization to address and close them, a backlog is created. This backlog puts a strain on the organization’s resources and must be dealt with quickly to prevent it from getting out of control.

CAPA Plan Implementation Process

The process for addressing these issues usually follows this path:

1. Open issue/event creation – this is a description of what happened, and includes who, what, where, when, and possibly why.

2. Assessment of severity – this is an assessment of risk to the patient, quality of the product, quality of the data, and other factors. Some companies have 2 levels (minor and major), while others have 3 (minor, moderate, and major).

3. Root cause analysis (RCA) – this is the process of discovering root causes of problems to identify appropriate solutions to prevent the same event from occurring in the future. Common tools used here are the five whys, fishbone/6M (man, method, machine, mother nature, measurement, and material), causal factors charting, and fault tree analyses.

4. Development of Corrective and Preventative Actions (CAPA) – this is determining which actions to take to prevent future occurrences of the event in question (or similar ones in other areas). The extent and implementation timing of each action is determined following an evaluation of the frequency of occurrence of the identified root cause and the impact of the issue.

5. Review/approval of RCA and CAPA plan – a team of resource owners and technical experts typically approve the RCA and CAPA plan.

6. CAPA plan implementation– this is the full execution of the plan.

7. CAPA plan effectiveness evaluation– the organization must allow enough time for the plan to be implemented and to take effect while maintaining a sense of urgency around ensuring that the root cause is addressed and will not occur again. It is important to note that some CAPA actions can be implemented and assessed very quickly, while others may spread out over several months. Organizations often have time frames/metrics around CAPA implementation and effectiveness checks that consider the complexity and urgency of the CAPA plan.

Having a deviation/CAPA program that is in control is a right to operate, meaning it is a baseline expectation of regulatory bodies when it comes to pharmaceutical manufacturing. If your deviation/CAPA program appears to be out of control, you can expect increased scrutiny into your quality management systems. When your organization finds itself with a large and growing backlog of events, it is extremely important to find your way out of it as quickly as possible.

Addressing Backlogged Events

So, how do you recover? We recommend addressing the issue on several fronts:

1. Beg, borrow, buy additional resources to address the events in the backlog. This is a brute force approach to reducing backlog quickly but can be effective if the resources that approve the RCA/CAPA Plans can keep pace with the additional resources that are assessing and doing RCA.

2. Perform an RCA on why your deviation/CAPA program is not producing the desired results. Examples include:

· Turnover

· New processes being implemented

· High rate of change to existing processes

· Overly complex processes

· Equipment issues

· A fragile, unrobust, or overly complex RCA/CAPA process

3. Assess your CAPA plans. The following are examples of critical questions to ask during this assessment:

• Are the organization’s root cause investigations not finding actual root cause, leading to CAPAs which don’t really address the issues?
• Are most events being labeled as some form of human error?
• Does the organization find many CAPAs that start with “update procedure to…” or “retrain staff to…” or “provide communication to staff to…” which means that it may be dealing with an ineffective training program or overly complex systems for the frontline staff to navigate?
• Do you have a backlog of CAPAs, which leads to recurrence of events with the same root cause?
• Do you see actual reduction in the number of events issued based on the number of CAPAs implemented? If your deviation rate is increasing or remaining flat over time while multiple CAPAs are implemented, then the organization may need to take a hard look at its effectiveness evaluations.

The Road to Recovery

Let’s look at each phase of recovery. Ideally, the organization should work on all three simultaneously, but based on resources, that may not be possible.

1. For working through the backlog of items (deviations or CAPAs), it is recommended to prioritize the closure based on risk. If internal resources are available, this can save time and costs involved with training and getting external resources up to speed on the deviation process. However, many times, external resources are required to provide the necessary numbers of people to gather information and address the issues. This may be an indicator that the organization is understaffed—which may be a key contributor to the creation of the backlog.

2. How did we get here? When analyzing the event/deviation process, it is helpful to analyze data showing where substantial time is spent and where rework occurs. Once you have trouble points identified, study the reasons, and adjust. This is where the hard work comes into play—critically analyze what your resources are doing and determine if it adds value. Some important questions to consider are:

• Is the organization adding new products/overhauling existing ones, and this increasing reoccurrence rate?
• Have they downsized significantly from the past?
• Has there been a large turnover in staffing? Has there been a significant change in quality standards?
• Are the technical resources doing activities such as filing documents that could be delegated to someone else?
• If rework is occurring, why?

For all of these, it will be necessary to understand details. Many times, it all starts with the quality of the information documented at the time of deviation occurrence. This allows for a timely assessment of the severity of the deviation. Once the assessment is made, getting information to RCA leader or team is also imperative to meet timelines.

3. Are the CAPA plans effective at reducing or eliminating deviations? A critical judgment of the effectiveness of the CAPAs should be done. Note that you should err on the side of engineering controls to eliminate or reduce the opportunity for deviations….so cite a couple examples. Administrative controls should be used sparingly as long term solutions—however, they may be appropriate as an interim solution. Just remember to remove them when the engineering solution is in place! Use caution when implementing a CAPA plan when you have not determined a definitive root cause. You may be adding layers of complexity that are not needed and will cause different deviations in the future.

How Can We Help?

As a leader in deviation/CAPA support, Process Alliance enables our clients to better navigate situations where something didn’t go as planned, and to de-risk their manufacturing processes.

The post Taking Control of Your Deviation/CAPA Backlog appeared first on Process Alliance LLC.