Stuff i wish someone would've told me before i graduated from college - medical device industry ed

Stuff I Wish Someone Would’ve Told Before I
Graduated from College

Medical Device Industry Edition
Cynthia Juncosa, CSSBB, PMP, CBA, CQA
Miami, Florida
cynthia@leancompliancepartners.com

Lean Compliance Partners, LLC provides this presentation as an educational tool and does not provide legal advice.

19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 1

Terms You Will Hear


Topics for Today

Lean
Six Sigma GMPs GDPs Resources
5S


Image Source: http://www.lean.org/WhatsLean/

Why do Lean?
What do Customers want?
A Perfect Order every time
 On Time
 Complete
 Accurate
 Undamaged

Do more, Do it faster, and Do it cheaper!
extra


LEAN NEVER ENDS

Anywhere work is being
done, waste is being
generated…

it should be minimized or
removed to increase
efficiency


Lean is focused on…

Cutting waste
 Eliminating waste in the process and

constraints on continuous flow

Cutting Time
 Shorten cycle time (time

between customer order and
delivery)


Eight Non-Value Added Wastes
“Cash in the Trash”
Defects &
rework Excess queues

Overproduction Excess motion
by people

Non-value-added
processing Waiting time

Unengaged minds
Excess movement
extra

Where do I go to see the Waste?

extra
Image Source: http://blog.karmona.com/wp-content/uploads/2009/06/38519.strip.sunday.gif

Where do I go to see the Waste?

(where the action is)

extra

GEMBA

•Go See
•Ask Why
•Show Respect


Safety First
• Material Handling
• Workplace/Machine Hazards
• Chemical Handling
• Personal Protection

extra

Waste Impact on Process Capacity

Productive Use Productive Use
of Resources of Resources
Value-Added Value-Added

Non-Productive Use
of Resources Released
Non- Value-Added Capacity

Capacity is Eliminating waste
consumed by waste releases capacity
extra

3
Future State

TO


Elements of 5S + Safety


http://leanlogisticsblog.leancor.com/2010/10/06/3-tips-to-cross-functional-5s-projects/

Usually three views
determined through Value Stream Mapping

1 2 3
What you THINK it is.. What it ACTUALLY is.. What it SHOULD be..

Desired
Perceived Future State
Current State
extra
Actual
19-MAR-2013
Current State
© 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 17

Rapid Improvement Event
Kaizen means “To Make Better”
 Structured process to fix areas of waste &
solve process problems
 Team uses Lean ideas to eliminate process
waste
 Focus on low-cost / no-cost solutions

Small Steps…Big Changes


Poke Yoke
• Error and Mistake Proofing of processes
– Easy to do correctly, hard or impossible to do wrong
– Engage, solicit solutions
– Respect for people and value they provide to solve
problems
– Excellent methodology to obtain and assure on-
going quality
• ROI = Priceless


Poke Yoke

Image Sources: http:// tqmatwork.blogspot.com/2011/08/poka-yoke, , http://www.keyence.com/topics/barcode/bl/pokayoke

Simple Principles & Methods

Standardized Work
• The best way to accomplish a task
• Apply to repeatable processes first
• Reduces training time, more consistent
output allows for better improvements


Simple Principles & Methods
Visual Management
• All employees understand
their impact on
performance – WHY

• Real-time information
and
feedback to react
accordingly

Image Sources: http://KANBAN_Heijunka_Boards_Plantafelstaender_AW_01 from orgatex.de

Six Sigma

Image Sources: http://www.astm.org

Six Sigma

Define Measure Analyze Improve Control

Agree on project objective
D
Select appropriate metric
Gather process baseline performance data
M
Agree data is representative of problem
A Analyze data to determine true cause of problem
I Selected solution will fix the problem
C Monitor the process to sustain the improvements


Six Sigma Certifications

http://www.sixsigmadaily.com/certification/six-sigma-training-belt-levels

http://www.claromentis.com/blog/wp-content/uploads/2012/11/ISO-9001.png; www.wmdo.org; www.fda.gov

cGMP
(Current Good Manufacturing Practices)
=
QSR
(Quality
System Regulations)
=
21 CFR Part 820

21 CFR Part 820
Subpart A--General Provisions Subpart E--Purchasing Controls
§ 820.1 - Scope. § 820.50 - Purchasing controls.
§ 820.3 - Definitions. Subpart F--Identification and Traceability
§ 820.5 - Quality system. § 820.60 - Identification.
Subpart B--Quality System Requirements § 820.65 - Traceability.
§ 820.20 - Management responsibility. Subpart G--Production and Process
§ 820.22 - Quality audit. Controls
§ 820.25 - Personnel. § 820.70 - Production and process
Subpart C--Design Controls controls.
§ 820.30 - Design controls. § 820.72 - Inspection, measuring, and
Subpart D--Document Controls test equipment.
§ 820.40 - Document controls. § 820.75 - Process validation.


21 CFR Part 820
Subpart L--Handling, Storage, Distribution,
Subpart H--Acceptance Activities and Installation
§ 820.80 - Receiving, in-process, and finished § 820.140 - Handling.
device acceptance. § 820.150 - Storage.
§ 820.86 - Acceptance status. § 820.160 - Distribution.
Subpart I--Nonconforming Product § 820.170 - Installation.
§ 820.90 - Nonconforming product. Subpart M--Records
Subpart J--Corrective and Preventive Action § 820.180 - General requirements.
§ 820.100 - Corrective and preventive action. § 820.181 - Device master record.
Subpart K--Labeling and Packaging Control § 820.184 - Device history record.
§ 820.120 - Device labeling. § 820.186 - Quality system record.
§ 820.130 - Device packaging. § 820.198 - Complaint files.
Subpart N--Servicing
§ 820.200 - Servicing.
Subpart O--Statistical Techniques
§ 820.250 - Statistical techniques.


FDA’s Quality Definition
• 820.3(s): “Totality of features and
characteristics that bear on the ability of a
device to satisfy fitness-for-use, including
safety and performance

• Defined by customer needs and expectations.
• Customers’ perception of quality is the single
most important factor for market share and
profitability.


Quality Management System

Quality is
PRIMARY FOCUS of Organization

Quality is EVERYONE’S
RESPONSIBILITY

Quality System Hierarchy
Quality Policy
Quality Manual

SOPs

Work
Instructions

Records, Forms

21 CFR Part 820.5 – Quality System

Each manufacturer shall establish and maintain a
quality system that is appropriate for the specific
medical device(s) designed or manufactured, and
that meets the requirements of this part.


What does Part 820 apply to?
• Methods used in, and

• Facilities and Controls used for,

• Design, Manufacture, Packaging, Labeling,
Storage, Installation, and Servicing of

• All Finished Devices intended for human use


What does Part 820 apply to? Examples
• Raw Materials
• In-Process testing
• Expiration Dating
• Stability Testing
• Production Record Review (DMR)
• Deviations / Non-Conformance Investigations
• Complaints
• Quality Control
• Audits
• Records and Reports


Common GMP Issues
• Failure to calibrate equipment
• Failure to conduct finished product testing
• Failure to establish
– Quality control procedures
– Adequate training program
– Adequate written procedures for production &
process control
– Establish Adequate labeling procedures
– Adequate batch production records


What if we DON’T comply?
• Form FDA 483s
• Warning Letters
– Bad inspections lead to Form FDA 483s.
– Warning letters are more serious than Form
FDA 483s
• Product recalls
• Seizures of products
• Injunctions
• Criminal prosecutions
• Civil money penalties


Good Documentation Practices

A.L.C.O.A.
Attributable
Legible
Contemporaneous
Original
Accurate


GDP Do’s and Don’ts

• Do use indelible ink for
handwritten entries.

• Don't use Pencils and Erasable
pen inks for handwritten entries.
Should not use fountain pens or
other inks that smudge easily.

• No correction fluids allowed!
(e.g. Liquid Paper)

• Ensure all raw data is kept Keep all
raw data - it cannot be destroyed!
• Don't use post its, scrap paper or
other uncontrolled sheets to record
data.
• Entries are initialed / dated at time
they are made.
• Don't back-date or forward-date your
entries!



• Ditto marks or continuation lines / arrows
are not acceptable.

• Don't leave spaces blank designated for
handwritten entries. Cross out or "N/A"
and initial/date the blank spaces.

• Don't sign for another person or sign
another person's name.


How to Correct an Error
• Put a single line through incorrect entry, write in new entry next to it, initial
and date.

• Original entry must remain visible

• Reason for correction must be recorded

• Common abbreviations for entry error reasons that can be used are:
• EE – Entry Error
• TE – Transcription Error
• OW – overwrite.
• ALWAYS check
versus your SOPs
• Consult Quality reps for
additional actions
if required

http://my.ilstu.edu/~ccmclau/che141/laboratory/notebooksample.htm

http://uowblogs.com/studentlife/2012/10/09/lessons-learned/

Resources

http://www.fda.gov
http://www.iso.org http://www.fda.gov/MedicalDevices/default.htm

http://www.emergogroup.com
http://www.lean.org

http://www.pathwise.com

http://www.astdsfl.org http://www.pmi.org


Resources – www.asq.org

http://www.asqsefla.org/


Resources
You can find information related to Quality, Lean, Six Sigma,
Regulations and just about anything else through these outlets:


Resources – LinkedIn Groups


Resources from
Lean Compliance Partners
Website: http://www.leancompliancepartners.com

Twitter: @CynthiaJuncosa @LeanCompliance

Blog: http://lean-compliance.blogspot.com

LinkedIn: http://www.linkedin.com/in/cynthiajuncosa

Facebook Pages: https://www.facebook.com/LeanCompliance

Google+: Cynthia Juncosa, Lean Compliance Partners

Slideshare: www.slideshare.net/Lean_Compliance_Partners/

Stuff i wish someone would've told me before i graduated from college - medical device industry ed

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