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

2,637 views

Published on

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,637
On SlideShare
0
From Embeds
0
Number of Embeds
15
Actions
Shares
0
Downloads
1
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

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

  1. 1. 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
  2. 2. Terms You Will Hear19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 2
  3. 3. Topics for Today Lean Six Sigma GMPs GDPs Resources 5S19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 3
  4. 4. 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 4 Image Source: http://www.lean.org/WhatsLean/
  5. 5. 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! extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 5
  6. 6. LEAN NEVER ENDS Anywhere work is being done, waste is being generated… it should be minimized or removed to increase efficiency19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 6
  7. 7. 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) 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 7
  8. 8. 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 extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 8
  9. 9. Where do I go to see the Waste? extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 9 Image Source: http://blog.karmona.com/wp-content/uploads/2009/06/38519.strip.sunday.gif
  10. 10. Where do I go to see the Waste? (where the action is) extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 10
  11. 11. GEMBA •Go See •Ask Why •Show Respect19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 11
  12. 12. Safety First • Material Handling • Workplace/Machine Hazards • Chemical Handling • Personal Protection extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 12
  13. 13. 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 extra19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 13
  14. 14. 3 Future State TO19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 14
  15. 15. Elements of 5S + Safety19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 15
  16. 16. 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 16 http://leanlogisticsblog.leancor.com/2010/10/06/3-tips-to-cross-functional-5s-projects/
  17. 17. 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 Actual19-MAR-2013 Current State © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 17
  18. 18. 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 Changes19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 18
  19. 19. 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 = Priceless19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 19
  20. 20. Poke Yoke19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 20 Image Sources: http:// tqmatwork.blogspot.com/2011/08/poka-yoke, , http://www.keyence.com/topics/barcode/bl/pokayoke
  21. 21. 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 improvements19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 21
  22. 22. Simple Principles & MethodsVisual Management• All employees understand their impact on performance – WHY• Real-time information and feedback to react accordingly 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 22 Image Sources: http://KANBAN_Heijunka_Boards_Plantafelstaender_AW_01 from orgatex.de
  23. 23. Six Sigma19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 23 Image Sources: http://www.astm.org
  24. 24. 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 improvements19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 24
  25. 25. Six Sigma Certifications19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 25 http://www.sixsigmadaily.com/certification/six-sigma-training-belt-levels
  26. 26. 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 26 http://www.claromentis.com/blog/wp-content/uploads/2012/11/ISO-9001.png; www.wmdo.org; www.fda.gov
  27. 27. cGMP (Current Good Manufacturing Practices) = QSR (Quality System Regulations) = 21 CFR Part 82019-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 27
  28. 28. 21 CFR Part 820Subpart 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 processSubpart C--Design Controls controls. § 820.30 - Design controls. § 820.72 - Inspection, measuring, andSubpart D--Document Controls test equipment. § 820.40 - Document controls. § 820.75 - Process validation.19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 28
  29. 29. 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--RecordsSubpart 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. 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 29
  30. 30. 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.19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 30
  31. 31. Quality Management System Quality is PRIMARY FOCUS of Organization Quality is EVERYONE’S RESPONSIBILITY19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 31
  32. 32. Quality System Hierarchy Quality Policy Quality Manual SOPs Work InstructionsRecords, Forms19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 32
  33. 33. 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.19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 33
  34. 34. 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 use19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 34
  35. 35. 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 Reports19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 35
  36. 36. 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 records19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 36
  37. 37. 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 penalties19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 37
  38. 38. Good Documentation Practices A.L.C.O.A. Attributable Legible Contemporaneous Original Accurate19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 38
  39. 39. GDP Do’s and Don’ts • Do use indelible ink for handwritten entries.• Dont 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) 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 39
  40. 40. GDP Do’s and Don’ts• Ensure all raw data is kept Keep all raw data - it cannot be destroyed!• Dont use post its, scrap paper or other uncontrolled sheets to record data.• Entries are initialed / dated at time they are made.• Dont back-date or forward-date your entries! 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 40
  41. 41. GDP Do’s and Don’ts • Ditto marks or continuation lines / arrows are not acceptable. • Dont leave spaces blank designated for handwritten entries. Cross out or "N/A" and initial/date the blank spaces. • Dont sign for another person or sign another persons name.19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 41
  42. 42. 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 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 42 http://my.ilstu.edu/~ccmclau/che141/laboratory/notebooksample.htm
  43. 43. 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 43 http://uowblogs.com/studentlife/2012/10/09/lessons-learned/
  44. 44. Resources http://www.fda.gov http://www.iso.org http://www.fda.gov/MedicalDevices/default.htm http://www.emergogroup.comhttp://www.lean.org http://www.pathwise.com http://www.astdsfl.org http://www.pmi.org 19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 44
  45. 45. Resources – www.asq.org http://www.asqsefla.org/19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 45
  46. 46. Resources You can find information related to Quality, Lean, Six Sigma,Regulations and just about anything else through these outlets:19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 46
  47. 47. Resources – LinkedIn Groups19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 47
  48. 48. 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/19-MAR-2013 © 2013 Lean Compliance Partners, LLC http://www.leancompliancepartners.com 48

×