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Home → Complaint Handling Archive for Complaint Handling

Case Study Part 1: Packaging Complaint Investigation Posted by Rob Packard on November 9, 2015

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This article explains how to perform a packaging complaint investigation using a case study example of flexible packaging that was found open by a customer. This is part one of a two part article. The second part will focus on the CAPA Process. Specifically, containment measures, corrections, corrective actions and preventive actions.

This case study example involves a flexible, peelable pouch made of Tyvek and a clear plastic film. This is one of the most common types of packaging used for sterile medical devices. In parallel with the complaint investigation, containment measures and corrections are implemented immediately in order to prevent the complaint from becoming a more widespread problem. The investigation process utilizes a “Fishbone Diagram” to identify the root cause of the packaging failure. This is just one of several root cause analysis tools that you can use for complaint investigations, but it works particularly well for examples where something has gone wrong in production process controls, but we are not sure which process control has failed.

Once the root cause is identified, for the packaging complaint, then you need to implement corrective actions to prevent recurrence. In addition, FDA Clause 21 CFR 820.100 and ISO 13485, Clause 8.5.3 require that you implement preventive actions to detect situations that might result in a potential packaging failure in the future and implement preventive measures so that similar packaging failures are not able to occur.

Packaging Incident

The incident that was reported was reported by a distributor. The distributor told customer service that two pouches in a box containing 24 sterile devices were found to have a seal that appeared to be delaminating. Unfortunately the distributor was unable provide a sample of the delaminated pouches or the lot number of the units. Packaging issues and labeling issues are typically two of the most common complaint categories for medical devices. Often the labeling issues are operators errors or a result of labeling mixups, while the packaging errors have may be due to customers that accidentally ordered or opened the wrong size of product and therefore they may complain about packaging when there was actually nothing wrong. It is important to be diligent in the investigation of each packaging complaint, because if there is a legitimate packaging quality issue then there may be a need or a product recall as part of your corrective action plan.

Reporting of Packaging Complaint Investigation

A lot of clients do not want to report packaging issues as a Medical Device Report or MDR, because they are concerned about potential action by the agency or the negative publicity of the reported adverse event. Even if an injury or death did not occur with a sterile medical device, the quality issue should still be reported as an MDR in accordance with 21 CFR 803 because it could cause an adverse event such as a serious infection that could result in sepsis and death. If you think that this is an extremely conservative approach, you might be surprised to learn that 225 MDRs were reported in just October of 2015 for packaging issues. One random example is this report of a leaking contact lens vial in the following report:

Event Description

“It was reported that the lens vial was found to have little or no saline storage solution. This was discovered upon receipt and the product was not used.”

Manufacturers Narrative

“The lens and lens vial were not returned for evaluation. The lot history record was reviewed and there were no non-conformities or anomalies related to this complaint. Based on the information currently available the most likely root cause of the event is related to a leaking lens vial. The type of lens vial associated with this report has been discontinued and a new (redesigned) vial was implemented.”

Packaging Complaint Investigation when product IS NOT returne d

What the narrative above does not elaborate on is what was the specific investigation details for “lot history reviewed.” One of the most useful tools for performing this type of investigation is the “Fishbone Diagram”. There are six parts “6Ms” to this method:

materials, method, machine, “mother nature” or environment, “manpower” or people, and measurement.

Here are a couple of things that could have been done:

review the complaint log for other complaints with the same lot number and/or from a similar time period, lot of raw materials or packaging machine review the device history record for the lot to make sure that the number of units rejected as part of normal in-process and final inspection did not exceed pre-established thresholds for monitoring of the sealing process if retains of the lot are available, these might be retested to verify that the testing results after real-time aging remain acceptable the maintenance and calibration records of the equipment for manufacture and for testing may be reviewed to verify that no repairs were required and no equipment was identified as out-of-calibration

If all of the above fail to identify a potential cause for a packaging failure, then you might have a problem related to people or the environment. People includes the people sealing the product package and the users. The environment includes the temperature and humidity for storage of packaging raw materials, packaged product, sterilization conditions, storage conditions after sterilization and shipping conditions–including any temporary extremes that might occur during transit.

In our case study the product was not returned and we did not have the lot number. Therefore, we may need to review distribution records to that distributor and/or the customer to narrow down the possible lots to one or more lots. Then we would need to perform the same type of review of lot history records for each potential lot. In the future, the UDI bar codes that are on products and product labeling will facilitate the identification of lots, because the UDI bar codes will be scanned into each patient’s electronic medical record and the production identifier (PI) portion of the code will tell manufacturers exactly which production lot was involved.

Packaging Complaint Investigation when product IS returned

Sometimes you are fortunate enough to received returned product. The product should be immediately segregated from your other products to prevent mix-ups and/or contamination. After it has been determined that the product is safe to handle, the assigned investigator may inspect the product packaging to confirm packaging issues and to possibly destructively test the packaging to verify that the packaging returned meets the specifications.

Additional Resources

There are an enormous number of articles and studies on the topic of package testing and package design for sterile medical devices. If you have a question, you can probably find a dissertation or two on any obscure aspect of packaging you are interested. For example, Jordan Montgomery is a packaging engineer/technical fellow with Medtronic. He performed a thorough investigation comparing testing methods for the EN ISO 898-5 with the ASTM F88 method . A dissertation I read also attempted to correlate between burst test results and peel testing results for the same packaging.

Related Blogs

If you are interested in learning more about root cause analysis, then you should visit the following articles specifically written about this topic: Tweet Pin It

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Leave a Comment (1) → Complaint Investigation Case Study (21 CFR 820.198): Part 2 Posted by Rob Packard on January 27, 2015

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This article is part 2 of a two-part series specific to complaint investigation requirements as specified in 21 CFR 820.198 ( ) of FDA QSR. This second part explains how to perform a complaint investigation and provides a complaint investigation case study.


Last week’s blog  reviewed the requirements for a complaint investigation, while this blog includes the following information on how to conduct an investigation:h

How thorough should your investigation be? Investigation Methods Verification of the Cause Documenting Your Investigation Complaint Investigation Case Study

How thorough should your investigation be?

The depth of investigation should be appropriate to importance of the complaint. If a previous complaint of similar nature has already been investigated, the investigation may only gather enough information to verify that complaint has the same root cause. However, if a complaint involves an adverse event (i.e., is reportable under 21 CFR 803 ), then additional information needs to be recorded in the complaint record as per 21 CFR 820.198d:

Does the device fail to meet specifications? Was the device used for treatment or diagnosis? What was the relationship, if any, between the device and the reported event?

If the person gathering information from the complainant cannot immediately identify a cause code, or the incident involves a serious injury or death, then it is important to gather as much information as possible. Typically, the complainant will be asked to return the device to determine if the device malfunctioned.

Investigation Methods

A complaint investigation is not any different from any investigation you perform for a CAPA. The most critical first step is to determine the cause of the complaint. In order to determine the cause, you need to sample additional records and inspect the device if it is available. If the device is not available, you might also look at other product from the same lot that remains in inventory. The following article I wrote suggests seven ways to investigate a complaint when a device is not returned: .

One of the methods described in the article above is a Ishikawa Diagram or “Fishbone Diagram.” This is one of the five root cause analysis tools that I teach in my CAPA webinar ( ). Ishikawa Diagrams are an ideal tool for root cause analysis if you have no idea what the cause of the complaint is, because this tool provides a systematic process for narrowing down the potential causes, to the narrow few that are most likely. You are not required to use this tool, but you should describe in your complaint record what type of root cause analysis was performed.

Verification of Cause

Once you have identified the root cause, or at least narrowed your list to the most likely causes, you should then verify that the cause will actually result in the observed malfunction by recreating the scenario if possible. Ideally, you should be able to simulate the event that resulted in the complaint and demonstrate that you can reproduce the problem. This is important, because if you cannot verify the cause of a device malfunction, then you will have difficulty verifying effectiveness of corrective actions for an infrequent complaint.

Documenting Your Investigation

There is no specific format for the way a complaint investigation is documented, but most complaint records have a small section on the complaint form that allows them to write a short paragraph summarizing the investigation and the results. Unfortunately, most of the spaces provided on forms are completely inadequate for the amount of information that should be recorded. Therefore, the best approach is often to write, “See attached complaint investigation.” This is especially true if the complaint is reportable (i.e., requires MDR under 21 CFR 803 ). Good documentation is quantitative and specific. You need to identify which records were sampled as part of the investigation, and you should demonstrate that you have expanded your initial search to determine if the problem exists in multiple production lots of the same product code, multiple product codes within the same product family and any other product families that may use similar raw materials, design features, equipment, testing methods or procedures.

Complaint Investigation Case Study

If your company manufactures cast orthopedic implants for the knee and you receive a complaint for an implant that has a small imperfection in the bearing surface of the femoral implant, you may need to perform an investigation–especially if this has not occurred previously. You should request a return of the implant for inspection to verify that the imperfection is nonconforming and not just a cosmetic defect.

Your investigation should include review of the lot history record for the entire lot of implants–as well as any other parts that they may have been cast at the same time. All the process conditions identified throughout the manufacturing process should be compared to the validated process parameters. Special attention should be given to the inspection results that were recorded for the castings (i.e., radiographic inspection, fluorescent penetrant inspection and metallurgical inspection). Ideally, these inspection methods should be repeated for 100% of the production lot to ensure that the inspection results meet the acceptance criteria. Documentation of the investigation should include copies of all records that were reviewed and photos if visual inspections were repeated.

If you are interested in learning more about complaint handling, you might be interested in downloading the webinar that Medical Device Academy recorded last year for complaint handling and vigilance reporting ( ). Leo Lagrotte, a former FDA investigator that works on our team as a consultant, also recorded a webinar related to CAPA and complaint investigations ( ). We can also help you one-on-one with a current complaint investigation you are conducting. Please don’t hesitate to contact me. Mobile: 802.281.4381 or .

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Leave a Comment (0) → FDA Inspections-Complaint Investigation Requirements-Part I Posted by Rob Packard on January 19, 2015

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“FDA Inspections-Complaint Investigation Requirements-Part I” is a two-part series which provides an overview of 21 CFR 820.198 requirements. 

Last week, I received a message from someone asking for advice on how to perform a complaint investigation. She has a complaint handling procedure that explains how to determine if complaints are reportable ( ), and she is the complaint coordinator. Her procedure includes a list of pre-determined cause codes for the most common complaints the company has received in previous years. Her system does not require a complaint investigation if an existing cause code is identified. She would like to know how to perform an investigation if she receives a complaint that does not fit one of the existing cause codes.

Is It a Complaint?

Most discussions about complaint handling begin with the definition of a complaint [i.e., 21 CFR 820.3(b); ]. However, if a complaint is received during investigation of a device rather than use of the device, the FDA will still consider this as being “after release for distribution.” The reason is that release for distribution occurs at final inspection. If the device breaks during installation, the device was still distributed.

One last question. Is it correct to consider a complaint only when the device is live and not during the settings and installation process of the device? (The definition states “after it is released for distribution”, what do they mean by this?).

What is Required?

The FDA QSR section specific to complaint handling is 21 CFR 820.198 ( 8). There are seven subsections (i.e., “A” through “H”) that comprise the regulation.

Manufacturers shall maintain complaint files and establish procedures for complaint handling. Manufacturers must review and evaluate if an investigation is needed. Manufacturers must perform an investigation automatically for any complaint involving a device malfunction–unless an investigation has already been performed for a similar complaint. Separate files shall be maintained for complaints that involve adverse events that are reportable under 21 CFR 803 ( ). The content of a complaint investigation record is specified in this subsection. When the complaint handling unit is located at another facility, the records of investigations shall be reasonably accessible to the manufacturing establishment. When the complaint handling unit is located outside the USA, then the records must be reasonably accessible at a U.S. manufacturer or the location of an initial distributor. What Does the FDA Expect to See?

FDA inspectors are guaranteed to sample complaint records and CAPA records during every routine inspection. The complaint records sampled will typically be limited to a specific product family that has been selected as the focus of the investigation. Most companies have an electronic log of the complaints, and the investigator may request a sorted list that only includes complaints specific to that one product family. The investigator will already be aware of all of your reported adverse events associated with the product family, and there may be one or two records they specifically want to investigate. The investigator will also review the complaint log to see if there are any complaints with a description that sounds like it might be reportable–even though the complaint was not reported.

The investigator will verify that each complaint record includes the content specified in subsection “E”:

name of the device; date the complaint was received; any device identification(s) and control number(s) used; the name, address and phone number of the complainant; the nature and details of the complaint; the dates and results of the investigation; any corrective action taken; and any reply to the complainant.

In my response to the question that I received, I also included advice for how to conduct an investigation. In general, the investigation is no different than an investigation for any CAPA. The first step is to perform a root cause analysis. The second part of this article will explain the investigation process in more detail.

Register to receive email notification of new blog postings ( ), so you can read the second part of this article next week. If you are interested in learning more about complaint handling, you might be interested in downloading the webinar that Medical Device Academy recorded last year for complaint handling and vigilance reporting ( ). Leo Lagrotte, a former FDA investigator that works on our team as a consultant, also recorded a webinar related to CAPA and complaint investigations ( ). We can also help you one-on-one with a current complaint investigation you are conducting. Please don’t hesitate to contact me and ask for help: Mobile: 802.281.4381 or .

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Leave a Comment (0) → A Medical Device Complaint Management Auditing Approach Posted by Rob Packard on May 2, 2014

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In this blog, “A Medical Device Complaint Management Auditing Approach,” the author focuses on the benefits of utilizing the 7-step process approach.

Auditors typically focus on the requirements of how to handle complaints, but what do you do with complaints after the investigation? If the only reason why you “handle” complaints is because it is a requirement, you are extremely unlikely to gain product benefits from reviewing complaints.

Audit Checklists

Are you using an audit checklist to verify that your complaint handling process is compliant with the regulations and that your records include all eight requirements of 21 CFR 820.198(e)?

Audit checklists encourage auditors to ask close ended (i.e., yes/no) questions. For example:

Did you document your investigation? Did you document corrective actions taken? The Process Approach

The process approach to auditing is a seven-step process where the auditor interviews the process owner and individuals performing the process being audited ( ):

What is the process? What are the inputs to the process? What are the outputs of the process? With what resources is the process performed? With whom is process performed? How is the process done? Which process metrics are important?

Each step of the process systematically gathers information about the process. More importantly, however, the process approach identifies how the process being audited interacts with other processes. Evaluating the effectiveness of linkages is one of the primary benefits of the process approach. For example:

Which records are used as inputs to the complaint handling process? How many corrective action(s) were initiated in response to complaints?

Sometimes, an auditor using the process approach will find a “broken link.” If there is no connection between servicing of devices and the complaint handling process, this is a link that needs to be “repaired.”

The Most Valuable Step

Of the seven steps to the process approach, the last step frequently provides the most proactive suggestions for process improvements. The last step is when the auditor asks the process owner, “Which metrics do you gather for this process?” Often, this question is met with a blank stare. If the process is not being measured, then the process owner cannot proactively make adjustments before mistakes are made. Instead, the process becomes reactionary.

A reactionary process for post-market surveillance and monitoring of complaints allows the number of complaints to increase and cause additional problems. Therefore, each complaint should be categorized, and data analysis should be performed. Ideally, each complaint category should have a maximum threshold established for the frequency of complaints and the severity of complaints. The frequency and severity would be documented in your risk management file. You may even establish quality objectives for the length of time it takes to process complaints, and number of actual complaints.

Adjacent Link Auditing

Adjacent Link Auditing is an extension of the process approach to auditing. The principle behind Adjacent Link Auditing is that each process has adjacent processes in the process workflow. The process owners managing the previous process step (i.e., “upstream”) are internal suppliers, because they provide the records and physical product that is used in the process being audited.   Process owners managing the subsequent process step (i.e., “downstream”) are internal customers, because they receive records and physical product from the process being audited. Internal “Suppliers” and “Customers” have a stronger connection to the process than other departments, because they are directly connected to the process. Adjacent processes are intimately involved in creating process inputs or using the process outputs for the next adjacent step in the process. If you are interested in learning more about Adjacent Link Auditing Theory, please click here to read an article in OrthoWorld’s BoneZone magazine.

If you are interested in downloading an example of a complaint handling procedure, please click here . For learning more about the process approach to auditing, you can purchase a webinar on the topic (Recording May 2, 2014. Please email  to order. Cost is $129).

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Leave a Comment (0) → Complaint Handling and Medical Device Reporting Common Mistakes Posted by Rob Packard on April 1, 2014

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This blog, “Complaint Handling and Medical Device Reporting Common Mistakes” reviews complaint investigations, MDR procedures and adverse event reporting.  

You should already be well aware that deficiencies in complaint handling and Medical Device Reporting are two of the most common reasons why the FDA issues 483 inspection observations and Warning Letters ( ). Recently, I posted a blog about “Where to Focus your Medical Device Complaint Handling Training” ( ). The following is a summary of my responses to reader questions.

Complaint Investigations

What criteria do you think should be used to determine whether a complaint should be investigated or not?

There is only one acceptable rationale for not conducting an investigation of a complaint. If you don’t investigate complaints when required, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.198(c) – Complaints involving possible failure of labeling to meet any of its specifications were not investigated where necessary. Specifically, a missing IFU was reported in customer complaints, but no investigation was conducted. The rationale documented in the complaint record was “the missing IFU presented no patient risk.”

A missing IFU is “failure of labeling to meet any of its specifications.” Therefore, 21 CFR 820.198(c) requires you to conduct an investigation “unless such investigation has already been performed for a similar complaint and another investigation is not necessary.” This is the only rationale that is acceptable for skipping your investigation. To ensure that no one forgets to investigate a complaint, make sure you include a space in your complaint handling form that is specifically labeled as “S ummary of Complaint Investigation. ” This space should also include an option to cross-reference to a previous complaint record where a similar investigation is already documented.

A missing IFU is also considered misbranded product that requires correction (e.g., sending the customer a replacement IFU) or removal (i.

4 Key Parts to a Complete Product Complaint Handling Program According to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR observations for their deficiencies representing almost 4% of all observations. Medical device companies were cited 512 times for similar deficiencies to 21 CFR 820.198 or nearly 11% of all observations. The most frequent cause of these observations is that systems do not exist for receiving, reviewing, or evaluating complaints, or that the current procedures do not include provisions for adequate assessment of the complaints.    Maintaining an adequate complaint handling system is more than just a requirement, it is a good quality practice that can help assure your product continues to meet quality attributes after it leaves your control. Key parts of a complaint handling program include:    Written procedures  Collection and triage of complaints  Evaluation of complaints  Reporting and Trending  Written Procedures  All processes impacting GMP systems must be documented in controlled procedures and approved by the Quality Unit.    Collection and Triage  It is best to have a single point of contact for collecting complaints. Consider utilizing the same reporting system as for adverse events at this point because there is generally overlap in the evaluation of complaints for adverse events and vice-versa because some complaints may indicate quality issues (e.g. Lack of Efficacy). Each product complaint should be prioritized based on the possible implications. Complaints that may require FDA Field Alerts should receive the highest priority. Those that could indicate serious quality issues or impact patient safety should also be classified highly.    Evaluation of Complaints  The Quality Unit determines if investigation of the complaint is required and if so, how the complaint will be investigated. Written justification of the decision is documented with appropriate rationale. Whether or not return samples can be obtained is documented, as well as a review of retain samples, if appropriate. A decision to quarantine any material not already distributed should be made and documented. Critical complaints such as those that may require expedited reporting such as for certain adverse events or quality issues are expected to be reviewed immediately and possible root causes assessed.    Investigation should also include possible impact to other batches/units, the complaint history for the particular batch/unit, and a review of the manufacturing and laboratory records for possible deviations that could have led to the complaint.    Product complaint investigations should be completed within a standard timeline, generally 30 calendar days, from the time the company received the complaint. Some complaints, such as those involving third-party manufacturers, may require longer timelines. If the investigation cannot be completed on time, an interim report approved by the Quality Unit should be issued.   Reporting and Trending  Completed investigation and remediation reports should be distributed as necessary to internal groups and the company should respond appropriately to the customer/complainant. The final report should indicate if the complaint is confirmed or unconfirmed, including a documented rationale.    Appropriate corrective and preventive actions should be documented and completed for each confirmed complaint.    Complaints should be categorized so they may be tracked and trended. Categories may include defect type, system(s) impacted, product, dose, equipment, etc. Trend reports should be prepared for management review on a regular basis to identify trends and assure management is aware of issues that potentially impact product quality. The analysis should include a statistical evaluation, identification of outliers, and identify trends that indicate a need for process change or improvement.    When developing or assessing your product complaint system, consider the points above and assure your program does not end up as a statistic.    Chris Santarcangelo  Sr. Compliance Project Manager, ProPharma Group, Inc.    Photo via Wall Street Journal Blog   On the Blog: James Meckstroth is taking a closer look at Data Integrity... On the Blog: Understanding industry trends to improve your quality system. On the Blog: A look into the recently updated PDA Technical Report No. 56...