This is the presentation which contains the outcomes of the FDA audit or brief about how FDA audit was conducted and the observations from them. The FDA audit was conducted for medical device manufacturing and was cleared successfully.
2. A transformational initiative to shift the
medical device industry from a focus on
regulatory compliance to a focus on
quality maturity.
“ “
US FDA’s Case for
Quality
4. Audit Setup & Walk Through
Introduced Herself
Presented FDA Badge
Company Layout
Product List
Samples
Product Show & Tell
List of Customers
Relationship & Matrix of
Responsibilities
between ACE & MWPL
510 (k) Registration
Process Flow Chart
Sterilization
Stores Walkthrough
• Material storage and
labeling before
inspection
• Lot Number Allocation
and Bin Cards
• Rejected Material
Area
• Movement of Material
though each process
• IIR Process
Tool Room Walkthrough
• Guide Forming Process
• Flare Tube Process
• Sub Assembly Work
Instructions reviewed
• Movement of Material
• Storage of Material
• Handling of Rejects
Loops Mfg. Walkthrough
• Operator Questioned on
different Processes
• Work Instructions
reviewed
• Handling of Rejects
• Documentation
• In-process & Patrol
Inspection review
• Laser Printing process
Clean Room
Walkthrough
• Pass Box Operation
• Recording and
Measuring of
Environment
• HV Test Process
• Sealing Process
5.
-Inadequate Training is not a
good way to close a CAPA.
-How long do you keep a CAPA
Open?
Generating and
implementing solutions
Non-conformance- does not meet specifications.
Deviation- non-conformance that is accepted as is
Non Conformance OR Deviation
Historical Data triggers the
CAPA Process
Repetitive NC Or Deviation
-Collect Data
-Identify Probable causes using
fish bone diagram, 5 whys etc.
-How do you close a CAPA with
no Root Cause?
CAPA Process Begins
-Document all stages.
-Correctly determine why an event or
failure occurred, then focus CAPA
efforts on creating specific and effective
corrective actions
Identify the Root Cause
01 Corrective & Preventive Action (CAPA)
MWPL raised CAPA for every batch
rejection 3% and over
HISTORICALLY
6. Complaints need to be properly
described
Complaint Intake
Not all complaints need to be
investigated. However, If not
investigating need to justify
Investigation
A complaint could trigger a CAPA if
deeper investigation reveals a
systemic recurring issue
Complaint & CAPA
Has to be put in to gather more
information regarding the complaint
from the customer
Good Faith Effort
Describe all steps taken.
Be scientifically sound and Logical
Revise before closing
If it isn't documented, you didn't do it,
it never happened. DOCUMENT!
Document, Document
01
02
03
04
05
06
02 Customer Complaints
8. Needs to keep track of all
regulatory requirements as well
as standards used to maintain
safety and quality of products.
Management Representative
01 02 03 04 05
Work
Instructions
&
Procedures
MRM
Plans
for
the
Past
3
years
Agenda
&
List
of
Attendees
List
of
Internal
Auditors
Audit
Plan
&
Records
04 Management Controls
9. Questions & Suggestions
1. How do you ensure that pouch is properly
sealed?
2. How was the boot strength test determined?
3. What is done if instrument or procedure is
found out of acceptable range?
• Pouch sealing 2 samples for each day would
not be enough.
• In validation report ,a column can be added
so that someone else also checks & approv
es it to avoid reading error.
• Keep a copy of ledger so that page which
document is stored can be found easily.
05 Validation and Calibration
10. A B
C D
PTFE inspection
Formed loop
Tyvek pouch
Incoming Inspection Reports
Incoming Inspection Report
Supplier rating procedure
Approved supplier list
Supplier Rating
Supplier Deviation Report
06 Incoming Inspection
11. Procedures for changes to
a specification and
method have not been ad
equately established.
Specifically, Performance
standards and test
methods applied by your
firm during your
production are not
reviewed to ensure that
the current versions are
used.
We plan to conduct a comparison
study. During the study should we
find any deficiency, we shall take
appropriate steps to correct it.
If not, using our document change pr
otocol, we shall change all mentions
of the standard to reflect the latest re
vised standard, referencing the comp
arison study.
a. IEC 60601-2-2 2009
Medical Electrical Equipment
Current revision 2017
Conduct a comparison study and will
ensure that new standard requiremen
ts, if any, are being met.
If no major changes impact our
procedures, using our document
change protocol, we shall change all
mentions of the standard to reflect
the latest revised standard.
b. DIN EN ISO 11607-2 2008
Guideline for the validation of the
sealing process;
current version 2018
07 Observations & Initial Response
If major changes impact our system, we will communicate to US FDA the
details of the planned test as well as new target dates.
1.
In addition, to prevent such an issue from recurring, a procedure will be put in place to ensure all standards used across
MWPL are listed with the current revision and a periodic review of all standards is made to ensure the latest revision is
being followed, with instructions of next steps in the case the standard changed impacts our procedures in any way.
12. Procedures for corrective
and preventive action
have not been
Adequately established
We currently lack a system to
conduct data analysis by which to
trigger a CAPA investigation.
Currently, it is our practice to conduct
an investigation at each instance of a
non-conformance(deviation).
We shall amend our CAPA procedure
to incorporate clear, timely,
appropriate review and analysis of
data sources to remedy this.
Target Date August 15th 2019
c. CAPA Data Analysis
There have been instances where
we have conducted a follow-up to
close a CAPA, but have not
documented this in our system. We
need to amend our procedures and
our forms to incorporate adequate
documentation of steps taken
during CAPA closure.
Target Date August 15th 2019
d. CAPA Documentation
Incomplete:
07 Observations & Initial Response 2.
There were instances observed where the proper root cause of the CAPA was identified, but not properly addressed in subs
equent changes to important documents like work instructions (SOP). The instructions did not clearly describe the preventio
n of the observed non-conformance, nor provide any warning or note to highlight the preventable non-conformance. To rem
edy this, we plan to review all our CAPA's for the last 2 years, and properly identify the main root cause. Once the root caus
e has been identified, a review of all related instructions will be made to ensure proper wording is used, such as warnings/n
otes/detailed information to ensure these preventable non-conformances are highlighted.
Target Date September 15th 2019
e. Root Cause not properly identified (i & ii):
Additionally, to prevent this from
happening again, we shall
amend our CAPA procedure to
specifically include a review of
the work instructions to
ascertain if any changes need
to be made to prevent
non-conformances found as
root cause in CAPA.
Target Date August 15th 2019
13. Process control procedure
that describe any process
controls necessary to
ensure conformance to
specifications have not
been established
07 Observations & Initial Response 3.
It was observed that the procedure for process control may not be the most effective way to
check for seal strength during process, and also that the procedure does not match with the
validation. The investigator would like us to have a link between the tests conducted in the
sealing validation process and during the sealing process control.
During the sealing validation process, the seal is tested for seal strength (Peel test), seal int
egrity (edge dip test and die penetration test). However, during the in-process testing, 2 se
aled pouches are checked for seal width, and a visual check for wrinkles, dust/debris, or im
proper sealing.
The seal should be effective in maintaining the sterile barrier. Our sterilized products are se
nt for sterility tests after sterilization, and to date, all of them have shown to have an intact s
terile field as evidenced by the test results. This ensures our seal strength is effective in mai
ntaining the sterile barrier.
As a quick remedy to the observation, we are in the process of introducing an edge dip test
for 2 sealed pouches , each time the sealing machine is switched off and then on.
Target Date August 15th 2019
ISO 11607-2:2017 Validation requirements for forming,
sealing and assembly processes
As a long term plan, we shall st
udy the BS EN ISO 11607-2:20
17 Validation requirements for f
orming, sealing and assembly p
rocesses to update our validatio
n process. We will update our v
alidation protocol with the above
and include more data points to
properly determine the frequenc
y and type of testing that needs
to occur. Updated design of exp
eriment (Validation protocol)
Target Date: August 31 2019
