Complaint Handling

Packaging Complaint Investigation – Case Study

This is part one of a case study on how to perform a packaging complaint investigation when packaging is found open by a customer.

Screenshot 2015 11 08 at 11.58.18 AM Packaging Complaint Investigation   Case Study

Overview of Packaging Complaint Investigation

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 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 malfunction. 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.

Description of the packaging malfunction

The first step of the complaint handling process (see SYS-018, Customer Feedback and Complaint Handling) is to record a description of the alleged quality issue. A distributor reported the incident that was reported. 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 to 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 operator errors or a result of labeling mixups, while the packaging errors may be due to customers who accidentally ordered or opened the wrong size of the product. Therefore they may complain about packaging when there is nothing wrong. It is essential 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 for a product recall as part of your corrective action plan.

Initiation of the packaging complaint investigation

In your complaint record, you need to assign a person to investigate the complaint. The only acceptable reason for not initiating an investigation is when a similar incident was already investigated for another device in the same lot or a related lot (i.e., packaging raw material lot is the same and the problem is related to the material). If the complaint was already investigated, then the complaint record should cross-reference the previous complaint record.

The person assigned to investigate the complaint must be trained in complaint investigations and should be technically qualified to investigate the processes related to the complaint (e.g., packaging process validation). The investigator must record which records were reviewed as part of the investigation, and the investigation should be completed promptly in case regulatory reporting is required or remedial actions are needed. It is also necessary to demonstrate that complaints are processed in a consistent and timely manner (e.g., average days to complaint closure may be a quality objective). 

Regulatory reporting of packaging failures

We know everyone wants to avoid regulatory reporting because we are afraid that other customers will lose confidence in our product and bad publicity may impact sales. However, the consequences of failing to file medical device reports with the FDA are much worse. Even if an injury or death did not occur with a sterile medical device, the quality issue should still be reported as an MDR under 21 CFR 803 (see SYS-029, Medical Device Reporting) because a repeat incident could cause an 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 251 MDRs were reported to the FDA in Q4 of 2023 for packaging issues. Of these reports, only one involved an actual injury, and the other 250 involved a device malfunction but no death or injury. The following event description and manufacturer’s narrative is an example:

Event Description

“It was reported by the sales rep in japan that during an unspecified surgical procedure on (b)(6) 2023 the rgdloop adjustable stnd device sterile package was not sealed and was unclean.Another like device was used to complete the procedure.There was an unknown delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.”

Manufacturers Narrative

“This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).”

Packaging complaint investigation when product IS NOT returned

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 a packaging complaint investigation is the “Fishbone Diagram.” Other names include, “Ishikawa Diagram” and “Cause and Effect Diagram.” There are six parts (i.e., “6Ms”) to the diagram:

  1. materials,
  2. method,
  3. machine,
  4. “mother nature” or environment,
  5. “manpower” or people, and
  6. measurement.

What records can be investigated without the return of the product?

The following records could be reviewed and evaluated for potential root causes even if the customer does not return the packaging with the alleged malfunction:

  1. review the complaint log for other complaints with the same lot number and/or from a similar period, lot of raw materials, or packaging machine
  2. 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 the sealing process
  3. if retains of the lot are available, these might be retested to verify that the testing results after real-time aging remain acceptable
  4. the maintenance and calibration records of the equipment for manufacture and 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 include the people sealing the product package and the users. The environment consists of the temperature and humidity for storage of packaging raw materials, packaged products, 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 numbers. 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. The best approach is to request a photo of the package labeling, including the UDI bar code, because that information will facilitate lot identification. Even if the product was discarded, often the UDI will be scanned into the patient’s electronic medical record (EMR) during surgery.

Conducting investigations when product IS returned

Sometimes you are fortunate enough to receive returned products. The product should be immediately segregated from your other products to prevent mixups and/or contamination. Normally the returned products are identified as non-conforming products and quarantined. After the quarantined product is evaluated for safety, the assigned investigator may inspect the packaging in a segregated area. Packaging investigations begin with visual inspection following ASTM F1886. If multiple packaging samples are available, or the packaging is large enough, the investigator may destructively test (i.e., ASTM F88) a 1” strip cut from the packaging seal to verify that the returned packaging meets the original specifications. If you kept retains of packaging with the same lot of flexible packaging, you may visually inspect and destructively test retains as well.

Next steps of the packaging complaint investigation

Once the root cause is identified for a packaging complaint, then you need to implement corrective actions to prevent a recurrence. Also, 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. If you are interested in learning more about conducting a root cause analysis, please read our blog on this topic: Effective Root Cause Analysis – Learn 4 Tools.

This article is the first half of the packaging complaint investigation case study. The second half of the two-part case study explains the necessary containment measures, corrections, corrective actions, and preventive actions to address the root cause of the packaging failure.

Additional packaging validation resources

There are many articles on the topic of package testing and package design for sterile medical devices. If you want to learn more, please register for our free webinar on packaging validation by Jan Gates.

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Complaints handling mistakes – Why?

Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why?complaints Complaints handling mistakes   Why?

Reasons for FDA 483s related to the CAPA process

You should already be well aware that deficiencies in the CAPA process, complaints handling, and medical device reporting are the three most common reasons why the FDA issues 483 inspection observations and Warning Letters in 2023. The most common reason for an FDA 483 inspection observation is related to the CAPA process (i.e., 336 observations citing 21 CFR 820.100). For the CAPA process, all 336 observations cited problems with inadequate procedures or inadequate records.

Reasons for complaints handling mistakes

The complaints handling process is the second most common reason for FDA 483 inspection observations (i.e., 276 observations citing 21 CFR 820.198). The complaints handling process has nine different reasons for 483 inspection observations (listed from most common to least common):

  1. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,*** 
  2. Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, *** 
  3. Records of complaint investigations do not include required information.  Specifically, *** 
  4. Complaint files are not [adequately] maintained.  Specifically, *** 
  5. Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
  6. Records for complaints where no investigation was made do not include required information.  Specifically, *** 
  7. Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***
  8. Investigation records of MDR reportable complaints do not include required information.  Specifically, *** 
  9. Records of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).  Specifically, ***

Reasons for FDA 483s related to Medical Device Reporting

There were 106 observations related to medical device reporting (i.e., 21 CFR 803) in 2023 thus far. There are 25 different reasons identified by the FDA for 483 inspection observations related to the Medical Device Reporting regulation. The majority o of the inspection observations were related to an inadequate or missing MDR procedure. However, there were also a number of inspection observations that were related to missing information in the MDR records. Therefore, we updated our Medical Device Reporting Procedure to include all of the required elements of the FDA’s MedWatch Form. We posted a blog about “Where to Focus your Medical Device Complaint Handling Training.” In that blog we answered questions from device manufacturers and consultants regarding the process of complaints handling investigation. The following section is a summary of my responses to those questions.

Complaints handling 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 investigating 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 the 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 a “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 “Summary 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 a misbranded product that requires correction (e.g., sending the customer a replacement IFU) or removal (i.e., recall). The FDA expects a Health and Hazard Evaluation (HHE) form to be included in your recall records, and the HHE should indicate the potential risk of a “delay in treatment.” This is the FDA’s conclusion in their evaluation of risk, and therefore your HHE must identify a delay in treatment as a patient risk too. The FDA also expects a CAPA to be initiated to prevent the recurrence of this type of labeling error. You can make a “risk-based” determination that reporting a specific recall to the FDA is not required as per 21 CFR 806.20. However, you need to maintain records of your determination not to report a recall. If you already received a Warning Letter, you should err on the side of reporting anyway.

Note: References to “recall” in the above paragraph are meant to include field corrections.

Intended Use

If a complaint consists of a medical device being used for something other than its intended use, is an MDR required for this user error?

The answer is yes. If you don’t report adverse events involving “user error,” then you might receive an FDA Form 483 observation worded like this…

21 CFR 803.17(a)(1) – The written MDR procedure does not include an internal system which provides for the timely and effective evaluation of events that may be subject to medical device reporting requirements.  Specifically, several incidents where a death or serious injury occurred were “caused by a user error,” and the procedure did not identify this as an event requiring Medical Device Reporting.

In 21 CFR 803.3, the FDA defines “caused or contributed” to include events occurring as a result of:

  1. Failure
  2. Malfunction
  3. Improper or inadequate design
  4. Manufacture
  5. Labeling, or
  6. User error

It is important to understand that the definition of complaints and the requirement to report adverse events should not be “risk-based.” The need for remediation and the need to report corrections and removals can be “risk-based,” but whether something is a complaint, and whether it is reportable should be “black-and-white.” For example, “Did the death or serious injury occur due to auser error’-including use other than the intended use?” If the answer is yes, then it is a complaint and reportable.

Incidents and Adverse Event Reporting

Do incidents that occurred outside the United States need to be reported to FDA?

The answer is yes. If you don’t report adverse events that occur outside the United States, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.50(a)(1) – An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused, or contributed to, a death or severe injury. Specifically, several instances were identified where the device caused or contributed to a death or serious injury, and the event was not reported to the Agency. The rationale documented in the complaint record was that the “event occurred outside the United States.”

This type of mistake is most likely due to a lack of training on 21 CFR 803–Medical Device Reporting. Some manufacturers that distribute products internationally are more familiar with the European Vigilance requirements as defined in Articles 87-89 of Regulation (EU) 2017/745. You can find additional guidance on vigilance reporting in our Vigilance Procedure or the applicable MDCG guidance. The European Medical Device Directive (i.e., MDD) only required vigilance reporting of incidents that occurred outside the Member States of the European Economic Area (EEA), Switzerland, and Turkey if the incident required implementation of field safety corrective actions. The EU MDR now requires reporting of incidents that occur outside of the EU if the device is also made available in the EU.

The FDA Part 803 requirements are worded differently. Part 803 does not indicate that the event had to occur in the United States. The MedWatch form (i.e., FDA Form 3500A) must be filed for events that occur in the United States and events occurring outside the USA if the devices are “similar” to devices marketed in the USA. Unfortunately, most device manufacturers are not aware of this requirement. Therefore, the FDA released a final guidance on Medical Device Reporting requirements on November 8, 2016. If you would like to learn more about Medical Device Reporting requirements, you can purchase our MDR procedure and webinar bundle. We will also be expanding our consulting services in January 2024 to include Medical Device Reporting for our clients.

Additional Resources on Complaints Handling

Medical Device Academy sells a complaints handling procedure, and a webinar on complaints handling. We will be updating the procedure during the holidays and hosting a new live complaints handling webinar on January 4, 2024. If you purchase the webinar, or you purchased the webinar in the past, you will receive an invitation to participate in the live webinar in January. If you purchase the complaints handling procedure, or you purchased the procedure in the past, you will receive the updated procedure, updated complaints handling form, and updated complaints log. You will also receive an invitation to the live webinar because we will be bundling the webinar with an updated procedure. We will also provide a discount code during the live webinar for people to upgrade their purchase of the webinar to include the purchase of the procedure. Customers who purchased one of our turnkey quality systems will also receive access to the live webinar.

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Complaint Investigation Case Study (21 CFR 820.198): Part 2

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.

complaint part 2 Complaint Investigation Case Study (21 CFR 820.198): Part 2


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

  1. How thorough should your investigation be?
  2. Investigation Methods
  3. Verification of the Cause
  4. Documenting Your Investigation
  5. Complaint Investigation Case Study

How thorough should your investigation be?

The depth of investigation should be appropriate to the 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:

  1. Does the device fail to meet specifications?
  2. Was the device used for treatment or diagnosis?
  3. 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 severe injury or death, then it is essential to collect 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. 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 an 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 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 the effectiveness of corrective actions for an infrequent complaint.

Documenting Your Investigation

There is no specific format for the way a complaint investigation is documented. Still, 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. 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 about 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 a review of the lot history record for an 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 ( 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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FDA Inspections-Complaint Investigation Requirements-Part I

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

complaint part 1 FDA Inspections Complaint Investigation Requirements Part I

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 an investigation of a device rather than the use of the device, the FDA will still consider this as being “after releasing 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 ( There are seven subsections (i.e., “A” through “H”) that comprise the regulation.

  1. Manufacturers shall maintain complaint files and establish procedures for complaint handling.
  2. Manufacturers must review and evaluate if an investigation is needed.
  3. Manufacturers must perform an investigation automatically for any complaint involving a device malfunction–unless an investigation has already been performed for a similar complaint.
  4. Separate files shall be maintained for complaints that involve adverse events that are reportable under 21 CFR 803 (
  5. The content of a complaint investigation record is specified in this subsection.
  6. When the complaint handling unit is located at another facility, the records of investigations shall be reasonably accessible to the manufacturing establishment.
  7. 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”:

  1. name of the device;
  2. the date the complaint was received;
  3. any device identification(s) and control number(s) used;
  4. the name, address and phone number of the complainant;
  5. the nature and details of the complaint;
  6. the dates and results of the investigation;
  7. any corrective action is taken; and
  8. any reply to the complainant.

In my response to the question that I received, I also included advice on 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 ( 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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Complaint Management Auditing

This article explains how to use the process approach to auditing to ensure more effective complaint management auditing.

inbound link building Complaint Management Auditing

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 that it is a requirement, you are extremely unlikely to gain product benefits from reviewing complaints. When you conduct complaint management auditing, you need to focus on linkages to other processes.

Disadvantages of checklists for complaint management auditing

Are you using an audit checklist when you conduct complaint management auditing? This will verify that your complaint handling process includes all eight requirements of 21 CFR 820.198(e), but it will tell you nothing about whether the process is effective.

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

  1. Did you document your investigation?
  2. Did you document corrective actions taken?

What is the Process Approach to Auditing?

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

  1. What is the process?
  2. What are the inputs to the process?
  3. What are the outputs of the process?
  4. With what resources is the process performed?
  5. With whom is a process performed?
  6. How is the process done?
  7. 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:

  1. Which records are used as inputs to the complaint handling process?
  2. How many corrective actions were initiated in response to complaints?

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

The Most Valuable Step in the Process Approach to Auditing

Of the seven steps to the process approach, the last step frequently provides the most proactive suggestions for process improvements. The final 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 the number of actual complaints.

Adjacent Link Auditing for Complaint Management 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 visit our webpage for SOP-018. For learning more about the process approach to auditing, please visit our YouTube channel.

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Where to Focus Your Medical Device Complaint Handling Training

%name Where to Focus Your Medical Device Complaint Handling Training

Medical Device Academy performed data analysis of FDA 483s for 2013 and identified four areas of focus for your medical device complaint handling training. 

One of the challenges of creating a strong training curriculum is the need for practical examples. This is why there are lots of stories about real-life companies and products in every Medical Device Academy training event. We learn more from our painful mistakes than we do from our success stories. When you recall a product, report deaths involving a product your company made, or if you receive a Warning Letter—these are events that we will never forget.

Medical Device Academy recently posted a blog ( about complaint handling, because this is one of the most common areas identified in FDA Form 483s and Warning Letters. Therefore, if you are trying to develop training on the topic of complaint handling (i.e., 21 CFR 820.198), then you should look for examples from your competitor’s mistakes. The following is a list of places you should look:

  1. Past inspection reports issued to your company by the FDA
  2. Any inspection reports or Warning Letters about your competitors that become public
  3. Other Warning Letters that mention complaint handling as an issue

Here’s an example of the type of 483 observation you might find: “Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).”

The example above identifies five different problems with a complaint process:

  1. You need a procedure 
  2. You need to designate a complaint handling unit
  3. You need to define the process for receiving complaints
  4. You need to define the process for reviewing complaints
  5. You need to define the process for evaluating complaints

21 CFR 820.198 is a prescriptive requirement in the regulations. Therefore, you not only need to create a procedure specifically for complaint handling, but you also need to ensure each element of the requirement is satisfied. This is important because FDA inspectors will verify that your procedure includes each element.

Medical Device Academy performed data analysis of FDA inspection reports for FY2013 ( to identify other common mistakes related to complaint handling. The data analysis of FDA inspection reports for FY2013 identified that there are 15 individual citations related to complaint handling that the FDA identified using the TURBO EIR System ( The table below summarizes the frequencies of these 15 sub-sections that were referenced in citations during FY2013 under the complaint handling category: 

483 Where to Focus Your Medical Device Complaint Handling Training

Medical Device Complaint Handling Training: 4 Critical Areas of Focus

The above table identifies several other sub-sections that present problems for companies. Based on the data analysis, your company should also be training your complaint handling unit in the following four critical areas:

  1. Maintaining complaint files
  2. Reviewing and evaluating complaints for the need to perform an investigation
  3. Documenting complaint investigations in your complaint files
  4. Determining whether a complaint is reportable under 21 CFR 803

The fourth area is one of the most important because these complaints involve injury, death, and product malfunction. Therefore, you might consider reviewing the TPLC database ( for MDRs. The best data to review is data for the same product codes that your company distributes, but reviewing any MDRs can teach your employees which types of incidents need to be reported. This area will also receive increased scrutiny with the recent changes to 21 CFR Part 803 (

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A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure

new 803 A Gap Analysis Tool for Updating Your Medical Device Reporting ProcedureThis blog shows you where to find the new FDA regulation for medical device reporting ( and the associated guidance document ( There is also an explanation of how to perform a gap analysis to compare your procedure for medical device reporting against the new 21 CFR 803 (

On January 22, 2014, Medical Device Academy posted a blog about how to create your own FDA medical device regulatory updates: That post identified a number of sources on the FDA website where you can locate information about new and revised FDA regulatory requirements. One suggestion was to register for receiving the RSS feeds from the following page: This page is where the FDA’s Center for Devices and Radiological Health (CDRH – posts news and updates.

If you registered for the RSS feed from CDRH, then you received an update on February 13, 2014, announcing the new Part 803 regulation for medical device reporting. This is NOT a cause for alarm. The fundamental change is simple:

Medical device manufacturers will no longer be allowed to submit FDA Form 3500A in paper form. It will need to be submitted electronically through the Electronic Submissions Gateway (ESG) (

ESG Sign-up

This is just another small step for the FDA to move toward digital records, and to integrate with electronic medical records from healthcare providers. The FDA even created a presentation explaining the process for electronic Medical Device Reporting (eMDR). This 8 minute and 45-second presentation are available on the CDRH Learning page: Slide 5 of the FDA’s presentation identifies the six steps for obtaining an account for an ESG:

  1. Get a test account with the ESG
  2. Send a letter to authenticate your digital identity (
  3. Get a digital certificate
  4. Contact CDRH (
  5. Test sending an MDR to CDRH
  6. CDRH approves production account with the ESG

I have been recommending that my clients switch from submission of the paper FDA Form 3500A to eMDR since 2010 when this training became available. Now, you have 18 months to switch over to eMDR before the August 14, 2015 deadline for implementation. Alternatively, you can also outsource your eMDR reporting to a  service provider that already has an ESG (

Comparison of Current & New Regulations

The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (, and copied and pasted each section into a Word document. We also did this for the current version ( Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents. If you would like to download this gap analysis, please visit the following webpage:

Gap Analysis of Your Medical Device Reporting Procedure

After you download the gap analysis tool that Medical Device Academy created, then you need to perform your gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meets the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).

Next Steps

  1. Download the gap analysis of the new and old versions of 21 CFR 803
  2. Review and update your MDR procedure to address the changes to 21 CFR 803 which are identified in the gap analysis
  3. Apply for an ESG WebTrader account for Low Volume/Single Reports
  4. Revise your training requirements for anyone responsible for MDRs:
    1. Complete all four applicable CDRH online training (
    2. Pass a quiz demonstrating training effectiveness (
    3. Review the draft procedure for potential errors or sections that are unclear
    4. Make any final revisions to the procedure based upon feedback from trainees
    5. Implement your revised procedure

If you need help completing the above steps, please contact Medical Device Academy by emailing Rob Packard, or by visiting the webpage for Medical Device Academy’s Complaint Handling and Vigilance group (

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7 Considerations for Outsourcing Medical Device Complaints


complaint handling 7 Considerations for Outsourcing Medical Device Complaints

Investigating medical device complaints can be a time-consuming task. This blog reviews seven considerations for outsourcing medical device complaints.

Two different clients of mine recently mentioned that they are overwhelmed by the amount of time required to investigate complaints and to file MDRs with the FDA. I suggested outsourcing the complaint handling to a third-party service provider, but they were unaware of any suppliers with that capability.

I was already familiar with several suppliers offering these services, but I wanted to know if companies were looking for these services. Therefore, I decided to post a discussion on one of the LinkedIn groups I manage: In just two days, there were 21 different comments. Most of these were from consultants offering their services, but their comments were helpful. For example:

  1. “The majority of complaint handling work typically involves a high volume of less critical tasks. Routine things like ensuring all potential complaints are entered into your system, requesting additional information when its needed, documenting updates when they are received, or drafting complaint/reportability decisions based on company policy are all tasks that can easily be performed by a well-qualified service provider for significantly less than if they were done domestically.”  – Matts Bell
  2. “Direct input into ESG is much better and easier than an additional third party software package, as ESG does change often, and the software companies are not keeping up. Keep in mind that each change digs deeper into the quality system and information. What is acceptable today may not be acceptable tomorrow as the validation keys within ESG tighten.” – Courtland Imel
  3. “I too, have provided outsourced complaint, NCMR and CAPA investigations, customer contacts, and root cause analysis to final disposition, sometimes in an FDA remediation project. But it requires active involvement on the part of the client company, with periodic meetings to discuss each case/its resolution, as well as identified trends/their resolution.” – John E. Lincoln
  4. “In the case of adverse events identified through the litigation process, the company cannot contact the complainant directly because the case is in litigation…Utilizing an appropriate third-party service provider to work with you on this process can make this type of adverse event reporting fast, efficient, and cost-effective.” – Melissa Becker

It is true that parts of complaint investigations must be performed internally—such as failure analysis. You also cannot outsource responsibility for review and approval of complaint records or MDRs. However, suppliers can provide trained personnel that are capable of initiating and completing complaint records, performing follow-up with complainants, and determining if complaints are reportable to the FDA and other countries around the world. One of the suppliers I interviewed can translate adverse event reports for countries that require reporting of adverse events in languages other than English, and they have a professional translator verify accuracy. Some personnel even have a medical background (e.g., nursing).

7 Considerations for Outsourcing Medical Device Complaints 

  1. Find a supplier that has many years of experience helping medical device manufacturers with complaint handling and adverse event reporting (no rookies)
  2. Ask for a demo of the software—web-based software is best (I’ll explain why shortly)
  3. Ask to see their complaint handling procedure and perform a procedure review
  4. Ask how the supplier handles complaint investigations when the product is not returned (
  5. Verify that the rationale for MDR decisions is based upon the FDA requirements in 21 CFR 803 (, and vigilance decisions are based upon MEDDEV 2.12/1 (
  6. Ensure that the software system has a tracking of timelines for complaint handling and reporting already built-in
  7. Ensure the electronic forms are adequately designed for capturing information—not just yes/no checkboxes everywhere

Why is web-based software better than hosted?

The US FDA is moving quickly toward Electronic Submission Gateways (ESGs) as the preferred method of submissions ( Unfortunately, there are frequent changes to ESGs that require software modifications and revalidation ( Therefore, unless you prefer to have a full-time person responsible for revalidation of software, web-based software solutions are typically your best choice for regulatory submission software tools. It’s also convenient to be able to access records and print them out for an FDA inspector from any computer. This eliminates any possibility of a 483 being issued against 21 CFR 820.198(f) (

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