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Managing a Quality System

 
Before anyone can manage a great quality system, they need to make sure it is developed the correct way. Developing a QMS is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s life cycle, from startup through maturity, the quality needs are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act that everyone in the industry encounters.
 
 
The most successful companies do critical assessments of their needs and gaps in the present and in the future, and then deploy a risk-based approach to their quality system to achieve their goals. Below is a breakdown of the 5 essentials to incorporate to effectively manage a quality system.
 
 

#1 Identify Your Needs

 

It’s critical to identify the quality standards, regulations and/or requirements surrounding the company’s products, service and business needs. Think about these major points when developing and/or assessing a quality system and how they apply within the company.

 

  • Geography – In which countries does the company manufacture, distribute or conduct business?
  • Industry – The type of product or service sector such as medical device, pharmaceutical, biologic, combination product, cosmetic, nutraceutical, service, or other?
  • Use Setting – Is the product used at home and/or institutional settings?
  • Regulatory Agencies – Is registration with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), etc.?
  • Standards – Certify to an international standard (i.e., ISO 9001, ISO 13485 or other) Is there a competitive advantage/or requirement to be registered
  • Manufacture – Are you manufacturing in-house or outsource to another manufacturer?

 

#2 Create Milestones to Analyze and Implement Upgrades

 

quality system

Creating milestones is one of the most important parts of having a great quality system, and it is the focal point of any phased approach to managing quality systems. The phased approach ensures that companies are meeting basic requirements in a timely manner with the expectation that there will be continuous improvement through periodic assessments and modifications with the existing quality system.

 

Main Elements of a Quality System

Management responsibility and commitment to the quality management system (QMS), ensuring ongoing communication with and support from the organization to follow the quality system.

 

  • Resource management – Ensuring the right people are doing the right things.
  • Employee competence against their job requirements.
  • Product realization – How is the product or service developed, transferred to manufacturing, and delivered to the customer while providing safety and efficacy.
  • Evaluation – What quality system metrics are used to assure compliant product and customer satisfaction, and drive continuous improvement.

 

#3 Use an Electronic QMS That Is Right for Your Company

 

When deciding how the quality system will be controlled it is important to understand different electronic QMS options based on the company’s needs. With electronic systems, there are ones that are controlled manually, electronically, or with the hybrid combination of the two. All these approaches can increase compliance, but their effectiveness depends on the scale, complexity, and needs of the quality system that’s in place. Typically, startup or early stage organizations can benefit from basic manual systems or hybrid systems that automate some of the more labor-intensive quality functions such as document control.

 

While midmarket organizations can benefit from increased automation through hybrid or enterprise QMS systems that address multiple quality needs such as document control, deviation control, nonconformance, equipment calibration, equipment maintenance orders, audits, corrective and preventive action (CAPA), change control, training, and functions that control product outputs. And large organizations can benefit from integrating enterprise QMS systems with their enterprise resource planning (ERP) and related systems for even greater interoperability.

 

 

Quality System Types
Type  Pros  Cons

 Manual, Paper-based
  • Low cost.
  • Easily changeable.
  • Time consuming.
  • Cumbersome as data grows.

 Stand-alone systems typically one or a few functions such as CAPA or document control.
  • Relatively low cost.
  • Effective for key single systems.
  • Generally requires minimal.
  • configuration, works right out of the box.
  • Minimal adaptability.
  • No integration with other quality functions.

 Enterprise QMS
  • Automates the entire quality function.
  • Modules are integrated.
  • Some systems integrate with the company’s ERP system.
  • Costly.
  • More resources/expertise to implement and maintain.

 

#4 Ensure Staff Is Properly Trained in Quality

 

With any position at any company, it is imperative that staff is properly trained, and part of that training must include how to utilize the quality system properly. No one wants to get flagged in an audit for something that could have been avoided by proper training. Companies require a competent and knowledgeable individual to be the quality system leader. They will oversee implementation, keeping the system compliant and pushing forward improvements.

 

It is also a part of the quality system leader’s job to ensure that either current staff is or can be trained on maintaining the quality system and if not, that the gaps are filled temporarily with contractors until the training is complete or the positions are filled. QMS leaders can perform a skills assessment to analyze the skills of in-house quality personnel against the company’s needs. Temporary gaps are common and can be closed by hiring consultants that can provide specialized knowledge without paying for a full-time employee. These include aren’t limited to:

 

  • Internal and external audits.
  • Regulatory training on key topics.
  • Medical liaison for complaints, clinical, etc.
  • Other complaint handling.

 

#5 Quality System Risk-Based Approach

 

When it is time to evaluate and start implementing changes in a quality system, the focus during the evaluation should be on risk and how to mitigate as much of it as possible. First, evaluate the areas of risk throughout the product lifecycle and identify what the greatest risks are. Once the major risks have been identified, find the areas in the quality system that are related to these risks and develop improvements to the prosses that mitigate the risk while still staying compliant. This approach ties in with No. 2 on the list, create milestones to analyze and implement upgrades. The milestones and upgrades created should be a part of this risked based approach.

 

Conclusion

 

Choosing the appropriate QMS and making sure it is managed the right way is crucial in any business’s success. When the quality system is not functioning in line with the companies needs it will have a ripple effect throughout the quality and compliance of the product and it is the Quality Manager’s job to make sure that the system operates smoothly. By using the 5 Essentials to Effectively Manage a Quality System above, leaders will know what to look for when evaluating their current system for improvements or will have a guide to creating a new, successful, system that is right for the company.

 

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21 CFR Part 11: Electronic Batch Records

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding 21 CFR Part 11 and electronic batch records.

 

Q. What is a master batch record (MBR)?

 

21 cfr part 11A. The MBR is the controlling document for pharmaceutical manufacturing. It contains the instructions and specific manufacturing processes needed to produce a particular product.

 

Additionally, the MBR ensures the ingredients needed to produce a product are correct. Each ingredient is added in the correct order, and the mixing and stirring used to produce the product are conducted in correct sequence.

 

Master Batch Record

 

For example, the MBR would list an ideal ingredient amount for the product. The completed electronic batch record would indicate the actual amount used for the individual batch. Moreover, electronic batch records are a requirement of 21 CFR Part 11 and is listed in Batch Production and Control Records section.

 

Q. Who is responsible for issuing the batch record to production?

 

A. Undeniably, world class companies have a document control department that is responsible for issuing the MBR to production. This department may or may not report to the quality department. Simultaneously, the most important item about releasing the batch record to manufacturing is that it needs to be tied to an actual production run.

 

21 CFR Part 11 Requirements

 

The pharmaceutical industry has very specific compliance requirements tied to traceability. The link that ties the MBR to the completed batch record is the lot number assigned to the product being manufactured. Naturally, each manufacturing run must have a different lot number for traceability and recall purposes.

 

Q. Can I release a batch record that has open investigations/deviations associated with it?

 

A. The 21 CFR Part 211 regulation states:

 

“There shall be a quality control unit that shall have the responsibility and authority to approve or reject … drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated”.

 

Consequently, the errors referred to include errors that occur during the manufacturing process.

 

Batch Production Record

 

If you are releasing a product that has electronic batch records associated with an open deviation/investigation then, in my opinion, the “error” has not been thoroughly investigated. Therefore, the bottom line is I would not recommend this practice.

 

21 CFR Part 11 Audit Trail Requirements

 

Unquestionably, audit trail documentation is vitally important when assessing risk if production goes awry. In my opinion, there is too much risk associated with releasing a product to the field with open investigations or deviations. Further, if the investigation result indicates the product has not achieved the specified quality attributes, by releasing it you have risked patient safety and may need to recall.

 

Q. In what order should I review information from electronic batch records?

 

A. I think we need to be clear on what we are discussing when releasing the batch record. Certainly, it includes a review of the incoming raw materials that include the active ingredient(s), excipients, primary packaging, and labeling.

 

21 CFR Part 11 Compliance

 

The batch record process for 21 CFR Part 211 compliance should verify these items were properly received and sampled. Nevertheless, each item should be put into quarantine until the incoming quality group established their suitability for use. Finally, this includes testing of the water used in manufacturing the product.

 

Critical to Quality

 

The review should confirm that all the materials used were appropriately discharged. Equally important, using calibrated equipment in a suitable environment. Without a doubt, cleaning manufacturing rooms before the start of the batch is critical to quality (CTQ).

 

FDA Electronic Signatures

 

The main focus of 21 CFR Part 11 compliance should be the details of the batch manufacturing itself. For instance, attention needs to be paid to make sure that any deviations during this phase of production have been resolved. In contrast, it is also important for FDA electronic signatures to ensure operators signed in the appropriate places indicating they performed the work.

 

21 CFR Part 11 Summary

 

Finally, there should also be an indication that another employee or a supervisor who witnessed the work. This is particularly important when verifying the right ingredients were discharged to the line to make the right product with the right dosage amount.

 

Lastly, many companies use a checklist to make sure all the elements of the master batch record are included in the product batch record. This is a widely accepted current good manufacturing practice (CGMP) in the pharmaceutical industry. Therefore, you should have confidence in releasing product batches when coupled with a thorough review of the contents. 

 

Article details

 

21 cfr part 11

 

 

 

 

 

Pharmaceutical Technology
Vol. 46, No. 12
Pages: 34

 

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CE Mark: Clinical Evidence Requirements

Preparing a Clinical Evaluation for a CE Mark is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon. Clinical evaluations are commonly problematic for industry. Improving the preparation process starts with tips from recent submissions.

 

A clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The EU MDR requirements for clinical evaluations are outlined in 2017/945, but some manufacturers don’t have history with the process. They could be facing challenges and rejections by the reviewers.

 

A clinical evaluation must be performed by device manufacturers pursuing the CE Mark prior to marketing the device in the European Union. Clinical evaluations are also repeated periodically as new clinical safety and performance information about the device is obtained.

 

The manufacturer demonstrates the device achieves its intended performance and that the risks and any adverse events are minimized and acceptable when weighed against the benefits. Claims made about the device’s performance and safety are supported by suitable evidence.

 

With regard to postmarket activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their quality management system (QMS). The QMS should use data generated from safety reports, including adverse event reports, results from published literature, any further clinical investigations, and formal post market surveillance studies.

 

Collecting Data

 

The literature review must be complete, covering pre- and postmarket data and any clinical investigations. In collecting data, it’s helpful to capture screen prints of searches, including the search terms and exact logic used in the search. Boolean logics such as “AND” and “OR” show repeatability and help the reviewers in analyzing the resulting clinical evaluation. For published and digital literature, it’s common for thousands of data sources to be identified.

 

Data Evaluation: The Heavy Lifting in Clinical Evaluations

 

After collecting the data, the next step is assessing the content and determining whether the data should be considered for the clinical evaluation.

 

regulatory complianceA scoring table can be useful for determining whether to include data. For example, data scored on factors such as device equivalency, application equivalency, similarity of operator, and demographic equivalency can be helpful during the analysis.

 

For studies that pass the scoring table, each must be summarized on how they support the essential requirements (see sidebar “The Clinical Evaluation Process”). A common mistake is simply copying the conclusion of the study instead of how it relates to the essential requirements.

 

Case Study: Class II device for breast biopsies

 

The manufacturer of the existing CE Mark device changed notified bodies. The new NB alerted the firm to numerous deficiencies in the clinical evaluation. The manufacturer decided it was beneficial to submit a new clinical evaluation.

 

The data collection resulted in 2211 papers. After an extensive analysis and scoring system, 27 papers were included in the clinical evaluation. A summary table was prepared for the clinical evaluation, which featured each paper and outlined the support of the essential requirements. The resulting clinical evaluation was approved without deficiency within 22 hours of submission.

 

Insights from the Experts

 

The clinical evaluation must be recreatable by third parties based on the process and scoring system outlined in the report. If the notified body can’t recreate it, they have no recourse except to find deficiency.

 

Make it easy for the CE Mark reviewers to check off each step. Highlight what they’re looking for relative to what you’re covering. Refer to guidances and standards that come from trusted industry sources.

 

Common errors can include the following:

  • Missing inclusion or exclusion criteria
  • Omitting applicable papers
  • Summarizing papers instead of evaluating them. Although a summary is required, the more important (and often omitted) portion is to explain how the data support the essential requirements
  • Forgetting summary tables
  • Forgetting a concluding argument. Explain how the document fulfills the requirements for the clinical evaluation.

 

Conclusion

 

Clinical evaluations include the assessment and analysis of the medical device’s clinical data to verify its clinical safety and performance. The stages are well-defined but can be intensive. A thorough clinical evaluation can involve thousands of data sources and significant time for proper assessment. Manufacturers should submit evaluations that are recreatable and make it easy for reviewers to follow.

 

 

regulatory compliance

Complete article published on Medical Device and Diagnostic Industry.

 

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ALCOA and ALCOA+

Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new acronym has on my company’s data integrity program?

 

ALCOAA: Before we get into the reason for the additions to ALCOA, referred to as ALCOA+, we should review what both of the acronyms mean. The acronym ALCOA requires data be attributable, legible, contemporaneous, original, and accurate. The acronym ALCOA+ adds the concepts that, in addition to ALCOA, data also needs to be complete, consistent, enduring, and available.

 

ALCOA & ALCOA+

 

It is important to understand what each element of ALCOA and ALCOA+ mean in order to apply the concepts appropriately with respect to a company’s records. The following are some general definitions, paraphrased from the Pharmaceutical Inspection Co-operation Scheme (PIC/S), that can be used for understanding the elements of ALCOA and ALCOA+:

 

  • Attributable: The data generated or collected must be traceable back to the individual who generated the information.
  • Legible: The data recorded must be readable and permanent.
  • Contemporaneous: The results, measurements, etc. must be recorded at the time the work is performed.
  • Original: Original or source data are the record, report, notebook etc. where the data point was initially recorded.
  • Accurate: The data recorded must be complete, consistent, truthful, and representative of facts.
  • Complete: Information that is critical to recreating and understanding an event. This would include any repeat or reanalysis performed on a laboratory test sample.
  • Consistent: The data are presented, recorded, dated, or time-stamped in the expected and defined sequence.
  • Enduring: The data or information must be maintained, intact, and accessible throughout their defined retention period.
  • Available: The data or information must be able to be accessed at any time during the defined retention period.

 

Data Integrity

 

Data integrity has always concerned regulatory authorities, but it is important to understand what is prompting the renewed discussion of ALCOA and the introduction of ALCOA+ when discussing data integrity issues. Many of the concepts for ALCOA have been captured in the regulations as far back as 1978. Since that time, the industry has changed dramatically. The generic-drug industry has grown and in the United States alone accounts for more than 80% of the prescriptions written today.

 

Product Lifecycle

 

Coupled with the emergence of biosimilars, virtual companies, contract manufacturing organizations, rapid advances in automation and information technology, and the globalization of the industry have resulted in reinterpretation of the attributes associated with maintaining the integrity of data throughout the product lifecycle, whether those data are generated from electronic, paper-based, or hybrid systems.

 

Quality Control

 

In addition, there has been an increase in citations internationally by the FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organization (WHO), and other health authorities. These changes and increased violations have brought about a resurgence and need to reeducate the industry. Additionally, basic principles of quality control and concepts regarding the proper control of data used to support the quality and safety of medicines.

 

EudraLex

 

The ALCOA acronym has been used since the 1990s; however, the requirements governing data elements have been in regulations for a much longer period of time. EudraLex chapter 4 states,

 

“Suitable controls should be implemented to ensure the accuracy, integrity, availability, and legibility of documents. Instruction documents should be free from errors and available in writing”.

 

21 CFR 211

 

The US Code of Federal Regulations (CFR) refers to these elements in various sections of the regulations. An example for language speaking to the element of attributable is in 21 CFR 211.194(a), which states,

 

“The initials or signature of the person who performs each test and the date(s) the tests were performed.”

 

21 CFR 58

 

Language in 21 CFR 58.130 (e) addresses the elements of contemporaneous and legible by stating,

 

“All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data.”

 

World Health Organization (WHO)

 

Recent documents issued by WHO and the PIC/S (1) have added to the original ALCOA attributes as indicated above. The PIC/S document actually states,

 

“Some key concepts of GDocPs are summarized by the acronym ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate. The following attributes can be added to the list: Complete, Consistent, Enduring, and Available. Together, these expectations ensure that events are properly documented and the data can be used to support informed decisions.”

 

WHO refers to ALCOA+ in the title of Appendix 1 to their 2018 document. The last two documents also address the concept of quality culture (10). The impact to your organization is that the quality culture must ensure that data supporting the quality and safety of your product must now meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

 

Article Details

 

 

Pharmaceutical Technology
Vol. 43, No. 10
Page: 77

 

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FDA Audit & Inspection Model

It is no surprise that over the course of 2021 with the COVID-19 pandemic that businesses have adjusted their model to accommodate FDA audit remote work. Whether that be associates working from home, reducing/adjusting personnel flows or implementing social distancing and mask wearing.

 

Everyone has been affected in one way or another. Some organizations already had contingency plans in place while others have had to adjust on the fly. The Food and Drug Administration (FDA) is no exception and FDA audit inspections are evolving as well.

 

Updated FDA Guidance

 

The FDA released updated guidance in 2021 for industry on remote inspections. While I doubt the FDA will move to a 100% remote inspectional model, I do think different strategies can accomplish their inspectional mission.

 

Also, the FDA started using a hybridized type of inspection approach earlier this year. Simply put, a hybrid approach to inspections (or audits) is using a mixture of virtual tools to help reduce time onsite. Time will be spent onsite doing facility walk throughs and testing, while the balance of the audit will be offsite doing document review.

 

MHRA & EMA Audits

 

Also, it’s not just the FDA performing these types of inspections. Others like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) are performing virtual audits all over Europe. Keep in mind that these regulators are all connected. As collaboration between regulators increases, we’re moving to a sort of “global” regulatory body. Adjusting to this type of approach can be ideal if you are prepared and understand what will change.

 

Section 706 of the Food and Drug Administration, Safety and Innovation Act of 2012, gives the FDA authority to “obtain certain records and other information from drug manufacturers in lieu of, or in advance of inspections.” This gives the FDA the statutory authority to obtain files such as a list of deviations, list of corrective and preventative actions (CAPAs).

 

Additionally, change controls, complaints since the last FDA inspection, validation documents, batch records and master files may be obtained. This authority covers essentially anything related to GxPs. These are some of the typical things an investigator is going to ask for or could be requested beforehand. Some investigators have even come in for the inspection but go outside to review documents or interview staff if it is a nice day.  

 

With the implementation of the hybrid approach to inspections the FDA is still using a risk-based approach to select companies to inspect, but they have modified it slightly, not only protect the manufacturing site and personal, but to also protect their investigators.

 

FDA Rating System

 

In July, the FDA sent out an announcement saying they’re using a rating system to assist them in determining where and when it’s safest to conduct inspections and call it prioritized domestic inspections. They are assessing the COVID-19 rates in specific areas or regions, or in this case in the United States. Then they decide where is it mission critical to do these inspections, but with the overall caveat that these inspections will be conducted with the goal of protecting the FDA staff and site personnel.

 

Announced FDA Inspections

 

Along with the prioritized domestic inspections the agency also announced that they would pre-announce these prioritized inspections. Historically, domestic drug inspections were basically unannounced, surprise inspections. In this case, they’ve made this change for a couple of different reasons.

 

  • The site can have personnel available for the inspection.
  • The site is prepared ahead of time so neither the site nor the FDA wastes their time and resources.

 

FDA Audit Priority

 

The goal is to prioritize critical inspections that the FDA deems important for the public health of the United States over less critical inspections. They may have changed the process for the time being, but it is still risk-based, as it’s always been, and the most significant difference in the process is that more risk criteria on criticality and personnel risk is being taken into account.

 

FDA Audit Preparation

 

In preparation for a hybrid audit, prepare documents electronically beforehand that may be audited. There is going to be a lot of electronic document review within the hybrid approach. So that means preparing ahead of time, and thinking through the entire inspection from an electronic or virtual perspective. Start working on minimizing paper by scanning files so they can be reviewed electronically to ensure multiple people aren’t touching the same piece of paper, which is typically done during an onsite inspection.

 

Also, when dealing with electronic files you need to consider how to securely transfer electronic documents. Are you going to use applications like SharePoint or Dropbox or use a transferrable flash drive?

 

FDA Audit Social Distancing

 

Other things to consider when preparing for a FDA audit or hybrid inspection is how to ensure social distancing. Consider the arrangement of the front room where the investigator is sitting to the conference rooms (aka “back room”) for document reviews. Your team should think critically in advance about how the inspection process will work. Some companies have added plexiglass dividers on their conference tables or removed chairs to ensure the six-foot distance.

 

Other things you should think about include the following:

 

  • What technology will you use for video inspection portions of the FDA audit?
  • What does that video look like?
  • How is the internet connectivity around the facility?
  • How strong is the Wi-Fi signal throughout the facility?
  • Do you need to boost the signal to ensure smooth video and sound feeds?
  • Do you need to practice (ex: mock virtual inspection) ahead of time?

 

Little things like these can mean a lot in an inspection. Critically thinking through the FDA inspection process from start to finish and preparing ahead of time are key.

 

FDA Virtual Audit

 

One key item to focus on during a virtual audit using online videoconferencing is the Wi-Fi signal. If you have dead spots in your facilities, it will interrupt the Zoom stream and cause problems. There are certain areas in facilities, like a maintenance/engineering area, that are notoriously loud and have bad signals.

 

Before an FDA audit takes place, you should do a thorough walk though, check connectivity and install Wi-Fi repeaters in those low connection areas. You should remember that the overall goal in these inspections is to enable the investigator or inspector to conduct the FDA audit.

 

FDA Audit Inspector

 

The audit inspector should be able to:

 

  • go where they want
  • see what they want
  • whenever they want
  • and how they want it

 

When you don’t have good Wi-Fi connectivity and the video goes out, it becomes problematic for the facility. This can be an annoyance to the investigator or the inspector leading the FDA audit.

 

Conclusion

 

Prior planning precludes poor performance, so prepare ahead of time by thinking it through.

 

  • What could go right?
  • How do you ensure it goes right?
  • What could go wrong?
  • How do you ensure that it doesn’t go wrong?

 

Just like we do in industry, you assess it, see where there are gaps and correct them. The same things go with preparing for a hybrid audit ahead of time. FDA has also stated the it is ultimately the firm’s responsibility to assure the quality of their drugs and/or devices.

 

So, it’s not a time to slack off and try to cut corners because it can and will catch up to you. Preparing ahead of time for these hybrid inspections will help ensure that your inspection goes seamlessly, but be prepared for the unavoidable bumps, because they are bound to arise when using technology.

 

Published By MasterControl

 

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Lessons Learned From Investigations of Product Failures

Medical Devices

 

When a medical product fails in the field, everyone suffers — not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No one wants a product failure, least of all the liable company for its safety. Faced with a quality investigation crisis, the manufacturer has three priorities: (1) protect patients; (2) resolve the problem as quickly as possible; and (3) prevent the problem from recurring.

 

Any product failure threatens a huge loss of value, above and beyond liability, to the manufacturer. If investors lose confidence and share price falls, enterprise value is destroyed. Then, as the company dedicates resources to resolving the problem, their other jobs — such as new product development — don’t get done (or, at best, don’t get done as quickly).

 

Risk Management

 

Since innovation is the beating heart of the medical device industry, any delay of a new product launch can cost a manufacturer millions; time really is money. All the more reason that quality investigation speed is so important in fixing any product problem.

 

Yet, many companies are not really prepared for product failure because they lack a crisis playbook. Through our work in helping companies investigate and resolve product failures, Regulatory Compliance Associates and The Science Cooperative (Chicago, IL) have gained the following insights about what works (and what doesn’t) in managing a product crisis.

 

“First Responders”

 

quality investigationA problem is identified as serious when field events indicate a trend beyond isolated incidences. At that time, the company’s leadership has to make a few decisions: Should an official notice be released? Should the product be recalled? Everywhere or only in some markets? Should production be stopped? In multiple or select plants?

 

Prompt action generally contributes to good will and positive publicity during a quality investigation. But the challenge is a deficit of facts at this stage since the forensic investigation itself hasn’t started.\

 

Standard Operating Procedure

 

In putting together a crisis playbook, a company should begin with guidelines and policies to direct the first responders in evaluating the size of the threat and the appropriateness of various options for response, depending on the apparent scope and severity of the problem.

 

For example, if a product is one component in an assembly, perhaps the best response is for multiple supply chain owners to work together to find the optimal fix for the problem. Among other issues that could be decided in advance would be choosing the “point man” for making that happen.

 

Risk Assessment

 

Of course, a crisis playbook would also help business leaders evaluate the cost of alternative responses. Say the chance of the company’s product being the cause of the crisis is 20 percent and pulling it off the market would cost $500 million: what’s the optimal strategy for moving forward?

 

Scenario-based planning provides a context for weighing alternatives and options during a quality investigation. But above all else, the first responders would want to stop patient harm; protecting the safety of the patient population comes first.

 

Functional Forensic Teams: Divide & Conquer

 

After the first responders have reviewed the situation and decided there is cause for escalation, it’s time to identify an investigation leader/crisis manager, an investigation leader, and the functional forensic team(s). An attorney or senior executive with strong project management skills is a good choice for crisis manager; also, each team needs at least one a member with strong organizational skills.

 

Product Validation

 

The crisis playbook should cover roles and responsibilities — including potential action checklists — for multiple functional forensic teams across the quality investigation. It’s feasible that a crisis might require teams in R&D, sciences, manufacturing, distribution, supply chain, human resources, legal, regulatory, quality, environmental, sales/marketing, and communications, as well as sub-teams for representatives from affected countries and from government affairs.

 

What expertise would each team require? What would be each team’s scope and focus? Most important, how should the teams interact, coordinate activities, and measure progress toward milestones and a final resolution? A crisis playbook should provide answers, which would vary case by case.

 

Project Management

 

Good project management skills are fundamental to managing the investigation process effectively and efficiently. Although the teams are all working on the same problem, each requires its own plan and milestones.

 

Role-based accountability for project and team-specific organization, documentation, schedules, data management, and reporting can be decided well in advance of a crisis. It’s best that the leaders of the crisis management team meet daily to assure clear, timely, cross-functional communication and to agree on next steps.

 

Resources: Knowledge & “Know-How”

 

If valuable resources are taken away or distracted from their jobs to any significant degree, real and measurable enterprise value is destroyed. So, while leaders and experts from each affected corporate function play a vital role in an investigation, it may be a smart business strategy to bring in specialists to support the effort with their expertise and experience.

 

In addition to minimizing damage to the company’s value and brand, the quick building up of expertise also speeds up the forensic process itself. One client asked both the FDA and EU notified bodies to participate in an investigation; as a result, the company tripled its lab capacity and bolstered credibility with shareholders and the marketplace.

 

FDA Investigation

 

Independent consultants can add muscle to any FDA investigation, while buttressing investor confidence. As an added benefit, because they’re beyond the “politics” of the enterprise, they can often give employees the freedom to speak without repercussion. Also, outside resources with the right knowledge and “know-how” will be well versed in Corrective and Preventive Action (CAPA) processes and can use this expertise to streamline and speed up the investigation.

 

Roadmap: Imagine a Practical Path Forward

 

Each team needs a directed course of action based on scenario planning. Given a set of variables that would vary by product and case — including (but not limited to) the severity of the crisis, geography, financial liability, and the possibility of substitute products — what steps should each team take to contribute to the problem identification, resolution, and ongoing prevention? 

 

The steps required of each team can be captured in “punch lists” to minimize redundancy and duplication of effort. Then, it’s relatively easy to assign responsibility for each item on the list. If the product is used in more than one country or region, the work of the corporate teams needs to be mirrored by local teams, and everyone’s findings need to roll up to the top.

 

Root Cause Analysis

 

 

Perhaps one of the most critical points in the quality investigation roadmap — and the one that’s most often missing — is a “stop” point. The longer an investigation goes on, the more enterprise value it can destroy.

 

So, in the beginning, it is important to decide: When is the problem solved? Is it when the contaminant is found? When the process in the factory or the supply chain is fixed? Or when the product is reintroduced to the market? Among these inquiries is another with implications for continuous improvement: Why didn’t the QA processes in place (for design, manufacturing, and other functions) detect the potential failure?

 

Scope control is a fundamental component of good project management. In most cases, there’s no need to parse the problem beyond a practical solution. The crisis playbook should include prototype action plans, checklists, work streams, decision processes, schedules, milestones, resource requirements, budgets, and documentation.

 

Steps for Post-Crisis Resolution:

 

  • Assure that all commitments made have been honored.
  • Update all prevention measures, including software procedures and policies, as appropriate.
  • Debrief the crisis management teams to mine “lessons learned”.
  • Ensure appropriate closure communication with key stakeholders, including regulatory agencies, media, customers, investment community, and employees.

 

Strategic Communication

 

From day one, the investigation leader/crisis manager needs to share information about commitments, expectations, and progress. Communication — internally with employees and externally with investors, supply chain partners, regulatory agencies, the public, and sometimes competitors — is critically important.

 

The overall process needs a “point person” for communication, as does each team, whether at the corporate or local level. The role of each communication channel — including press releases, internal newsletters or briefs, media contacts, video, and letters to shareholders and the investment community — can be planned well in advance: a crisis playbook can take chaos out of the process and enable the company to put its best foot forward. In communication, the current best practice is a dedicated portal, a single source for real-time updates on the investigation, typically accessible through the company’s Website.

 

Crisis Management

 

The old proverb “a stitch in time saves nine” captures the value of a crisis playbook: being prepared will save time and money down the road; most importantly, it could literally save lives. By being mindful of the components of effective and efficient crisis management — building up and deploying expert resources; coordinating and integrating parallel work streams; following and documenting rationalized processes — a company’s leadership can be confident in its preparedness to handle a product failure to the satisfaction of everyone’s best interests.

 

Article Details

Complete article published in Medical Design Briefs.

 

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