Susan Christie, Author at Medical Device Academy Medical Device Academy

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4 Things to Know When Selecting a Medical Device Consulting Firm

Posted by Susan Christie on November 4, 2013

The author reviews four things to know when selecting a medical device consulting firm, including defining the project scope, interviewing, budget, and contract.

Medical Device companies utilize consultants for various reasons, including a lack of technical expertise within the company, avoidance of hiring full-time employees for a relatively short-term project and gap analyses for FDA readiness, or notified body audit. Have you ever been tasked with choosing a consultant to help with a critical project, but the consultant you selected failed to meet your needs? Not to worry, you’re not alone. Unfortunately, consultants sometimes make commitments for work; they are not qualified to do. Here are four critical areas to consider when selecting a consultant to help ensure a positive and productive experience.

1. Defining the project scope

Ensure that the scope, timeline, roles of the consultant/ internal company team, and deliverables are crystal clear during consultant interviews and defined within the consulting contract. Do you need advice or suggestions to be carried out by your internal team? Or is “hands-on” work required (writing procedures, conducting training, executing audits, etc.)? I’ve discovered that “hands-on” can mean something entirely different to your company and the consultant. If it’s not clear who is doing the actual work, your internal resources may end up doing the work that was intended for the consultant.

Once the project scope has been clearly explained, ask the prospective consultant to provide a brief document describing how they would approach the project. This will be helpful later on when drawing up the contract. Ask which software or systems the consultant will be using to keep your project on track. A consultant who does not have any version of project management on their laptop, or is unfamiliar with such tools, is a red flag.

Make sure you select a consultant or consulting firm that matches the size of your project. Select and interview three to five companies, based on the size and complexity of the project. If the project primarily involves working at your location, consider the additional cost and travel time from where the consultant(s) is located. If the project allows for working remotely, focus more upon the project management aspects mentioned in the previous paragraph, and how your company will communicate with the consultant.

2. Interviewing

When selecting your consultant, don’t base your decision on word of mouth, or someone that you pick randomly online. Interviewing is an essential part of the selection process. Be wary of a consultant who talks more than listens, especially if the conversation is about their illustrious career. This person should be focused on the scope of your project and asking questions about your company and the project team. You also need to beware of consultants with a condescending attitude. If you are an experienced medical device professional, and the consultant starts to explain the definition of GMP, the consultant has not taken the time to understand their audience. Any consultant that is this disrespecting deserves to be chopped from your list of potential service providers early.

Don’t limit interviewing to the experience of the lead consultant or owner of the consulting firm. Make sure that you also have a resume or CV for each of the other consulting members that will be working on your project. Imagine the dismay of your internal team when you discover that the owner of the consulting firm has hired friends or former colleagues with little or none of the needed expertise. To prevent this scenario from occurring, include a technical person on the interview team to challenge the expertise of the consultant. This will help you identify a firm that knows all the right buzz words but lacks the knowledge to accurately implement the deliverables and reduce regulatory risk within your company.

Ask for and check references for past clients for whom they have done similar work. Ask for examples of work reports that the consultant has completed for other clients—with any confidential information removed. This is critical in determining if the final job will be “fluff” or real solutions for your company. It will also avoid the “one size fits all” procedures and processes that can rarely be beneficial for your company’s needs. Ask for examples of “out of the box” thinking and best practices that they’ve implemented. How do they remain current on the regulations and standards?

3. Budget

Cost should not be the only determining factor in selecting a consultant. When you’re choosing someone to pave your driveway, you may be able to get away with this. When choosing a consultant for your medical device company, you want several bids, and you want to ensure that each party is bidding against the same scope and deliverables. However, choosing the least expensive bid over the one with the most expertise and best reputation may cost your company more in the long run if the work isn’t properly done or completed on time.

4. Contract

Contracts must be very specific with regard to milestones, timelines, and deliverables with respect to the payment schedule. What recourse does your company have when a consultant assures you during the interview process that they can meet your every need and then doesn’t. No company wants to have to pay for work that hasn’t been done and may never get done.

Be clear about work accommodations – office, cube, conference room, phones, access to printers and company databases, so that there are no misunderstandings once the job starts or excuses for why the work can’t get done “under these conditions.”

Conclusion

Choosing the right consultant for your company is critical. They don’t come cheap, and if your staff could accomplish the work, you would not be hiring a consultant in the first place. If you are careful in your selection of a consultant or a consulting firm, you may be rewarded with a new partner that can help you grow your business for many years.

Tags: FDA medical device regulatory compliance, medical device consulting firm, selecting a medical device consulting firm, selecting a medical device quality consulting firm

Posted in: Project Management

8 success tips for the first 30 minutes of an FDA inspection

Posted by Susan Christie on September 25, 2013

The author presents an 8 item action plan and discussion for getting your FDA inspection off to a good start, beginning when the FDA enters your facility. When an FDA inspector arrives at the reception desk of your facility, the last thing that you want is a Keystone Kops scenario with people running around in a panic and keeping the inspector waiting. This is your first opportunity to make a professional impression, and you never want to give an inspector the impression that you have something to hide. What happens during the first 30 minutes of arrival is critical. While medical device inspections are often announced several days in advance, there is no obligation for the Agency to do so. Therefore, your team needs training and a plan. This training should involve more than just reading the Quality System Inspection Technique (QSIT) manual (http://bit.ly/QSITManual), and conducting a mock FDA inspection. Last year, Rob Packard wrote a blog about “10 FDA Inspection Strategies that Don’t Work” (http://bit.ly/QSITmistakes), but the following activities need to be executed in the first 30 minutes to ensure your next inspection starts smoothly.

The FDA Inspection: 8 Immediate Actions to Take

1. Receptionist-Personnel Contacts (Time Zero)

I once witnessed a receptionist sarcastically comment to an inspector that people must be thrilled when they walk in the door. That was not a great start to the inspection. Ensure that your receptionist and additional personnel who may sit at the desk are trained, understand what to do, and know-how to behave when an FDA inspector(s) arrives. This exercise should not cause panic. You need a simple work instruction located at the reception desk and a list of key staff members to contact immediately. The head of the Quality department, or Management Representative, is usually the first call.

2. Have Chain of Command in Place (Time = 1 minute)

DO NOT keep the inspector waiting in the lobby. Have a communication chain in place to ensure that other appropriate personnel is available in the event that the first point of contact cannot be reached. It is reasonable to ask the inspector to return at a later date ONLY if all individuals with the technical expertise to participate in the inspection are not on-site, or are out of the country. The agent will decide whether to honor this request, but the expectation is that there is always someone with whom they can work with. Never make this request to put off the inevitable.

3. Ask To See Inspector Credentials (Time = 2 minutes)

Ask to see the inspector’s credentials, and ensure that you give them more than a cursory glance. This is important to avoid allowing an imposter posing as an Agency employee from gaining access to your business. While a rare occurrence, it has been known to happen. Some investigators are officers of the Public Health Service and may be in uniform. However, even these officers are not required to wear a uniform for all visits. Note: Section 5.1.1.2 of the FDA Investigations Operations Manual (http://bit.ly/FDAIOM) instructs inspectors to provide their credentials to top management, but copying of official credentials is not allowed.

4. Escort Inspector to Inspection Room (Time = 5 minutes)

Make sure that you can have the inspector escorted to a suitable room with the respective hosts within five minutes of arrival. This will involve ensuring that it is clearly understood by all administrative staff and key management that any other meeting may need to be curtailed, or moved immediately to another location to provide an appropriate space for the inspection. Providing substandard accommodations, such as a very cold or warm room, is not a good strategy for shortening the inspection time, and is a ploy easily recognized by the Agency, though not appreciated. Note: Rob Packard taught an audio seminar earlier this year, where the use of inspection war rooms was covered in more detail—including a diagram with a proposed layout for the room (http://bit.ly/FDAInspectionSeminar).

5. Ready the FDA Inspection War Room (Time = 10 minutes)

Immediately after your inspection room is identified, you need to prepare your backroom or “war room.” This room should be located near the inspection room and set up at a moment’s notice with staff who can expertly execute their respective roles. You will need a mode of communication between the inspection and war rooms, runners to retrieve documents and records in the shortest time possible, as well as a technical individual to review these documents to ensure that they are appropriate and accurate before being provided to the inspector. This room should be ready within ten minutes of arrival.

6. Ensure You Have Emergency Supplies & Copies (Time = 15 minutes)

Your war room will need supplies. You should have a mobile cart equipped with inspection supplies ready and waiting at all times. Suggestions for the contents of your war room cart include a laptop, projector, staplers, staples, pens, blank folders, a label maker, and a stamp for “uncontrolled copies.” Your supplies need to make it to the war room within 15 minutes of arrival.

7. Ready the Frequently Requested Documents (Time = 25 minutes)

Don’t wait for the inspector to tell you which documents are invariably requested at the outset of any inspection. This includes, but is not limited to, the organizational chart, an index of all procedures, CAPA log, and your nonconformance logs for medical devices—all dating back to the last inspection. This doesn’t mean that you should offer these documents to the inspector. You want to prepare these before they are requested so that they can be provided quickly, but you should keep the copies in the war room until the inspector requests each document and record. Copies of these records and documents should be stamped and ready within 25 minutes of arrival.

8. Relax (Time = 30 minutes)

It sounds as though this process is a race against time. It is not. No one engaging with the inspector should be running in and out of the room, gasping for breath, or sweating profusely from the effort. Keeping the inspector waiting can be perceived as a stall tactic, perhaps arousing suspicion that you are creating records “on the fly” in the war room (definitely not a strategy that I recommend), or that you are having difficulty locating the requested documents, and are not in control of your Quality Management System (QMS). The most important aspect is to manage your QMS so that you are always ready for an inspection at a moment’s notice. If you prepare in advance, you shouldn’t need to do anything more than ask if the inspector would like coffee before the inspection begins.

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Tags: FDA, FDA inspection

Posted in: FDA

How to Utilize CAPA Training To Avoid FDA 483 Citations

Posted by Susan Christie on August 15, 2013

The author discusses how formal CAPA training can help solve the four most common CAPA deficiencies and help avoid FDA 483 citations.

Corrective And Preventive Action (CAPA) is considered to be one of the most critical processes in a Quality Management System (QMS). CAPAs prevent nonconformities from recurring, as well as identify potential problems that may occur within the QMS.

Both the Code of Federal Regulations (21 CFR 820.100) and the ISO 13485 Standard (8.5.2 and 8.5.3, respectively) include similar requirements for establishing and maintaining a compliant CAPA process. The concept seems pretty straightforward, right?

Then why do so many companies struggle with this process and go into panic mode during FDA inspections and Notified Body audits?

CAPA process deficiencies have long been the number one Good Manufacturing Practice (GMP) violation cited in FDA Warning Letters. Therefore, providing trained experts to teach the CAPA process is well worth the investment to provide your employees with the expertise needed to implement a sustainable, effective, and compliant process. Support from top management is a must for success.

7 Reasons Why There is LIttle Support for the CAPA Process

Managers view CAPA as a necessary evil and apply minimum effort and resources to complete the required paperwork.
All complaints, audit findings, shop floor nonconformities, etc., go straight into the CAPA system, resulting in what is known as “Death by CAPA.” There are hundreds of CAPAs to be dealt with, but the CAPAs languish and quickly become a mountain of overdue records.
The lack of ability to conduct effective root cause analysis results in, at best, a band-aid solution, and recurrence of the same issues time and again.
There is no risk-based or prioritization process that provides a triage for determining when a CAPA is appropriate, and how to classify its criticality.
CAPA forms are either too restrictive, such as using “yes/no” questions, thereby stemming the creative flow of process thinking or, too open-ended, leaving the CAPA owner with little guidance for getting to the exact root cause.
Trending and metrics that would highlight quality issues before they become complaints are lacking, so most CAPAs are last-minute reactions to a crisis, instead of proactive improvement projects.
Senior management has not allocated sufficient time and resources to CAPA owners to develop expertise, and clearly do not understand the nuances of FDA compliance, the ISO Standard, and the responsibilities of CAPA ownership.

Consequences of an Ineffective CAPA System: FDA 483 Citations Are Possible

FDA 483 observations, Warning Letters, and loss of your ISO 13485 certification are possible consequences of failing to manage your CAPA process. Imagine explaining to your customers why you lost your certification, and why they should keep you as a trusted supplier. That is not a conversation you want to have.

A weak CAPA process allows nonconformities to recur, results in manufacturing downtime, requires to rework, and ends with the scrapping of product or lost customers. The consequences of a weak CAPA process negatively impact your company’s financial strategy and goals.

To prevent an increase in the cost of poor quality, your business cannot remain static. You need to improve and adopt best practices. Your CAPA process is a systematic way to make those improvements happen.

Characteristics of an Effective CAPA system?

Easy to follow the procedure
Defined CAPA inputs
Risk assessment and prioritization
Root-cause investigation tools
A well-defined action plan
Metrics to track progress
Communication of information and status
Effectiveness checks
Management support and escalation

What to Expect from Formal CAPA Training

Death by Powerpoint is not training. Effective CAPA training requires hands-on participation in working through root-cause analysis with an expert. One of the best training tools is case studies based upon recent 483 observations. A CAPA training course should teach you how to:

Accurately identify the cause of problems
Prioritize your corrective and preventive actions using a risk-based approach
Implement an appropriate corrective and/or preventive action, and
Verify the effectiveness of your actions

CAPA training should teach you how to reduce the length and number of investigations. Training will also help you master current problem-solving methodologies to identify true root causes, utilizing facts, instead of guesswork or opinion. The proper identification of the exact root cause of a problem is critical because otherwise, your CAPA plan will fail to fix real problems.

Not all formal training needs to be in-person. Face-to-face training can be supplemented with more cost-effective training of concepts using webinars and recorded presentations. Interactive training is needed to supplement this training so that students can practice what they learn.

How Training Solves Common CAPA Deficiencies

The four most common CAPA deficiencies are:

Inadequate procedures
Incomplete investigations
Overdue actions, and
Failure to perform an effectiveness check

Each of these deficiencies is addressed directly by CAPA training. Formal CAPA training reviews each of the requirements for your CAPA process, and trainers will often share samples of CAPA procedures, and CAPA forms that they wrote and found to be effective. Learning multiple root cause investigation techniques, and practicing them using the case study technique, ensure that CAPAs are thoroughly investigated, rather than identifying superficial symptoms.

CAPA metrics are introduced during training to ensure that the CAPA process owner knows best practices for monitoring and analyzing the process. Finally, CAPA training includes specific examples of what is and what is not, a proper technique for performing an effectiveness check.

Results After Formal CAPA Training

The best reason for making formal CAPA training available to the people responsible for CAPAs are the results you will experience after the training. For example:

Elimination of hundreds of overdue CAPAs
Reduction in nonconformities, scrap, rework and customer complaints
Lower overall costs associated with quality problems
Better FDA inspection and Notified Body outcomes, and
Safer products for your customer

If you are interested in learning more about CAPA, click here to register for Medical Device Academy’s Risk-Based CAPA webinar.

Tags: CAPA, CAPA training, FDA 483

Posted in: CAPA, FDA