Tuesday, August 4, 2020


When your company team develops non-conformance / complaint / CAPA trend charts (usually from a spreadsheet), they'll need to ask the following questions and determine how to present and label / categorize the data presented so it can be acted upon (the key reason for collecting / trending in the first place):

  • Frequency - generally monthly presentations and also showing yearly for the bigger picture;
  • Areas charted, and Categories within each chart - should be based on risk of problem to the end-use / patient as no. 1, with business / financial / GMP compliance issues also important, but secondary;
  • Is all the above structured and presented to assist in getting to root causes, and addressing and eliminating the problem in a timely manner;
  • Is all the above designed to show resolution / effectiveness (e.g., a decline in the number of occurrences of each area / category) ;
  • How will each chart be presented to senior management; how will action be taken on each / triggers (monthly Alert at 1.96 sigma (annual); monthly Action at 3.0 sigma (annual), or ...); how will such action(s) be documented monthly (a Trend Meeting, Agenda, and Minutes?).

These (and possibly other) issues are what the CGMPs, especially CAPA (see 21 CFR 820.100 and note a.1-7) and the Trending requirements are driving.  The FDA (and any QMS, i.e., ISO 13485) want companies to have quality systems in place that recognize system and product / supply chain / manufacturing / testing problems, highlight those problems, and force / drive change (verified / validated / monitored for effectiveness) to eliminate those problems, then move on to the next inevitable group of problems. 

-- jel@jelincoln.com

Tuesday, June 23, 2020

Virtual Site Inspections / Audits in Times of Pandemic, et al

an approach ...

         Virtual Audits / Inspections, if applicable:  Using the information in a Vendor Audit SOP /
         Attachment, develop an Audit Plan / Script that can be conducted by a video
         conferencing tool, e.g., Skype®, Zoom®, WebEx®,  GoToMeeting®, MS-Team®,
         and/or the use of a phone camera or similar.  Enlist the help of a QA/QC contact
         person at the vendor to assist with the video. 

·     Obtain e-copies, pdf, or paper copies pre-sent of the QM, SOP Index / Titles, specific applicable SOPs, Establishment Registration Number, applicable 510(k) K numbers / dates, catalog (or website screen captures), certifications, last US FDA 483 if available, and so on;  
·     “Tour” their facility, taking visuals with the digital camera;
·     Focus on areas of interest to you, e.g., IQC, Inventory Storage, Manufacturing, specific work stations, FG QA, post-production activities, if applicable, and similar;
·     Video specific activities, specific documents related to your product (or obtain e-copies, pdf, or paper copies pre-sent;
·     Request additional supplemental videos, if needed, during course of desk audit.
                        ·     Compile a written “narrative” of the video for the file (or the actual video in 21                                    CFR11/system-validated storage.  

    -- jel@jelincoln.com  

         One Possible Approach to an Approved Vendor List

         Based on part / component criticality (to patient / end user / clinician).    

               Based on product risk, supplier / vendor audit results, incoming QC trend data,    
               and other factors, a list of approved vendors, and their criticality should be 
               established and maintained by QA, separately, or in each vendor’s file. 
Criticality (based on risk to the patient / end user / clinician):
Criticality Category
01.  Lab services – contracted – clean room 
       / controlled manufacturing area testing,   
       biocompatibility, EO / BI / gamma
       validation and testing, GMP
       compatibility issues
High (Major)
02.  Calibration services -- contracted
03.  Patient fluid path contact 
04.  Tissue, bone and dentin contact
05.  Sterile barrier
06.  Sterilization services – contracted
07.  Patient contact, general
08.  Test equipment, tooling, fixturing  
       manufacturers – company validated
Services / Equipment
09.  Equipment, tooling, fixturing;    
       manufacturers – company validated
Low (Minor)
Services / Equipment
10.  No patient contact
11.  Manufacturing Materials – fully    
       removed during processing (validated)

Ranking explained (reference:Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document”, May 11, 2005):


A failure or latent flaw could directly result in death or serious injury to the patient or operator. The level of concern is also Major if a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.
A failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also Moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Failures or latent design flaws are unlikely to cause any injury to the patient or operator


      6.11  Critical Vendors:  Suppliers / vendors ranked “High / Major” on the above tables     
               are determined to be “critical”.  Critical suppliers are to be subjected to an initial
               site (or virtual) audit.  Follow-up reviews / frequency will be determined by patient /
               user risk factors as mentioned above and/or a Product Risk Management File, and the
               quality of their deliverables, maintenance of their CGMP compliance and/or

               The type of vendors to be considered “critical” could consist of: 
               Independent test labs, calibration services, contract sterilizers, manufacturers of   
               critical / high risk components, compliance consultants, Notified-Bodies (generally
               will not be audited by the company, as they are subject to their own competent
               authority oversight), and similar. 

               Moderate risk vendors will be subject to an initial desk audit (see Attachment 1),
               supplemented by any additional follow up phone interviews (document in memo to    
               file) and/or e-mail correspondence (initialed and dated)

               All High and Moderate vendors will be subject to a periodic review, usually
               annually, as to performance, retention or replacement, and/or need for any
               supplemental re-audit / re-inspection; documented by a memo to their file.  

               Low risk ranked vendors will be subject to review / action if any deliverable is found
               non-conforming, and such review will be included in the NCMR or other CAPA

              --  jel@jelincoln.com 

Sunday, June 21, 2020

EU MDR’s Implementation Postponed for One Year
On Friday 17 April 2020, the European Parliament adopted the European Commission’s proposal to postpone implementation of tThe EU’s Medical Devices Regulation (MDR) 2017/745 for 12 months due to the COVID-19 pandemic and the potential impact it will have on EU MDR implementation. 
The proposal also has to be approved by the member states and published in the Official Journal of the European Union (OJEU) before it enters into force. This is to be by 26 May 2020 at the latest. Once in force, the new Date of Application for the MDR will be 26 May 2021.


Friday, June 5, 2020

Job Hunting

My response (slightly expanded) to a discouraged new job seeker on a forum.  Appropriate in view of the current job market.

The first job is the hardest. Get any experience you can including internships, temp and/or part time. Include responsible volunteer positions you may have filled. 

Try to get in front of the actual hiring person, rather than HR. Approach the hiring person with what you can do for them / their company, based on your research about their company on the Internet, friends who've worked there, etc. Do not focus on or imply you want the job to get a car and a place to live (your personal reasons). Focus on their needs and your proven qualities that would help them to meet those needs. 

For starters, I find it helps to compile a personal list of abilities, accomplishments, by going over my past life (several times), and writing down / listing those actions, projects, events, that I felt proud of, that were noteworthy accomplishments, that moved something forward, maybe in spite of problems / obstacles / challenges (not necessarily job related, but school, personal, sports, volunteer, community ...), and then rewriting them into business advantages / tools /qualities, using business terminology. E.g., were you successful in assisting in getting some activity started, running, and finished - see how that could be adapted to successfully leading / managing a business project (project management; self-starter, self-managed).  Change your personal terminology into business terminology -- learn some of the related tools, e.g., project management tools: flow charts, the Gantt Chart (easy to learn and implement on a word processing app or spreadsheet app. -- Google helps here for examples / explanations; and you don't need a certificate, just enough familiarity to adapt, define,  run, explain, and complete a small project).    . 

Have a "story", real examples, of how you would meet their business needs, by how you actually met similar needs / challenges in the past, the steps you took, your thinking / actions / approaches ... Role-play with a mature friend so your responses become 2nd nature. Expect and welcome open-ended questions, like "tell me a little about yourself'", by not giving your life story, hobbies, personal interests, but target your response - maybe even rephrase their question and then reiterate your qualities that fit their needs. 

And don't talk yourself out of a potential job interview because you think it doesn't seem to fit. If it appears close: Apply. Go. Do the above, and if the job offer doesn't come, at least it was their decision, not yours. You'll get more experience at job interviews, and, more importantly, I personally have seen other opportunities open from the same company when the initial job wasn't a fit, but they liked what I brought to the table, and knew of a future opening that would be a great fit. Look for openings before they're advertised by talking about what you're doing (and listening) with all your contacts, since there will then be less competition = networking. Be professional / modest in appearance (dress one step up from what would be called for in the actual position), conduct, language, conversation, word choice, etc. Minimize anything off-putting, e.g., piercings, tattoos, wild hair styles / colors, etc., unless those are typical of that workplace. 

And recognize that there will be many "nos" until the "yes", so don't let the experience affect your self-worth (easier said than done). Be positive and smile, even if you don't feel that way inside.

John E. Lincoln   jel@jelincoln.com

Wednesday, May 20, 2020

Don't let the current COVID-19 cautions stop your company's internal and vendor inspections / audits.  Learn remote approaches and tools to conduct successful cGMP compliance inspections / audits 100% remotely.  Check out my latest new webinar on:






Friday, May 15, 2020

Some of my upcoming webinars:

FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software 19-May, 2020 at 01:00 PM ET.

Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements 10-June, 2020 at 01:00 PM EST 

How to Deploy Root Cause & CAPA to Minimize Human Error 24-June, 2020 at 01:00 PM ET

Medical Device Change Management 08-July, 2020 at 01:00 PM ET