Production

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Production Process ControlsA
Business-Friendly Perspective

• Presented by
• Stan Bauman, Immuno-Mycologics, Inc.
• Krista Oakes, Amica Solutions

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Case Study A Company In Trouble

• 2 consecutive warning letters from FDA
• Complaint rate 10 of units sold
• Competitors using poor quality record against
  company
• CEOs view Quality system
  is a necessary evil

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Company After Business-Friendly Quality Approach

• Next FDA inspection no 483
• Complaint rate lt1 of units sold
• Competitors asking for contract manufacturing
• CEOs view Quality system is good for business!

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What Made the Difference?

• Company originally viewed quality requirements
  as conflicting with business objectives.

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The Difference

• Business-friendly approach complemented business
  objectives, and could be supported and sustained
  by all members of the organization.

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Overheard From Quality Folks

• Management doesnt support me.
• Why did they hire me if they dont want me to do
  my job?
• They CANT do that!
• Manufacturing is always trying to get away with
  something.

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Overheard From Management

• If I involve Quality, they will delay the
  release of my product. They dont understand our
  market window.
• We have to do X first, then worry about
  compliance later.
• Show me where it says that I HAVE to do
  it that way.

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A Quality Professionals Perspective
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Common Quality System Pitfalls

• Quality system activity initiated in reactive
  mode
• Management support lasts only as long as threat
• Quality function viewed as barrier to progress
  cost center
• Compliance approach has narrow focus

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Common Misconception

• Production Process Controls Burdensome
  Requirements Bureaucracy

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No Burden Here!

• Medical device regulations are necessarily broad
  and non-prescriptive
• FDA is prohibited from creating unduly burdensome
  requirements
• Requirements can (and should) be translated into
  value-added practices

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The Medical Device Industry

• Mostly comprised of small businesses
• Competition is global and rapidly increasing
• Essential survival needs
• Sustainable quality and regulatory compliance
• Operational efficiency profitability
• Competitive market position

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The Language of Management
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The Language of Management

• FDA says is not a sustainable motivation for
  quality systems.
• Management must understand that a good quality
  system will help them achieve their business
  objectives.
• Effective Quality professionals know how to speak
  the language of management.

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The Business-Friendly Approach

• Operations are viewed in context of business
  objectives
• Principles behind regulations are well-understood
  (the why)
• Focus is on best practice and added value
• One size does not fit all

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For ExampleOne Companys Problem

• Company struggles with high rejection rates at
  the end of the manufacturing process
• Delivery to customer is frequently delayed by
  rejections, causing customer service problems
• Finished product scrap rate is high and costly
• Tensions between QA and manufacturing personnel
  are high

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Business-Friendly Approach

• Business objective get good product out the
  door on time reduce waste
• Principles understand process, correct/prevent
  causes of rejects, control process upstream
• Best practice/added value focus resources on
  prevention instead of screening QA and mfg work
  together to optimize process

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A CEOs Perspective
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Why Does a Company Do Anything?

• The sole reason for a company to be in existence
  is to be profitable.
• If a company is not profitable, sooner or later
  it will cease to exist!

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• Production and Process Controls should be
  recognized and promoted
• as an asset for achieving
• Company objectives

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The Why Production Process Controls

• Patient has a reliable product
• Customers are happy
• Product waste is minimized
• Operations are more efficient
• Resources can be doing more and fixing less

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• Bottom line a healthier bottom line!

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Examples of Poor PPC

• Poorly or inadequately trained employees
• Inadequate controls over incoming materials
• Inadequate controls over in-house produced
  subassemblies in-process materials

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Examples of Poor PPC

• Poor equipment controls (validation, calibration,
  maintenance)
• Inadequate change control
• The result
• Product out of specification
• Product loss/waste
• Unhappy customers
• Costly product recalls
• Potential risk to patient

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Examples of Business-Friendly Strategies for PPC

• Establish controls to assure that new employees
  are not utilized beyond their training
• Establish the same acceptance methods for
  in-house produced materials as for externally
  acquired materials
• Minimize opportunities for error (make the right
  path the easiest path)

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Some Examples Used in a Small IVDMC

• Employee Training
• On-line Training Log For each New Employee
• New Employee cannot be assigned to a job that
  uses a piece of equipment until signed-off on
  that equipment by a manager.
• Training Log is job-type specific.

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Some Examples Used in a Small IVDMC

• 3 QA Acceptance Levels for Incoming Materials
• Level I count and breakage inspection
• Level II Level I mfg. spec. sheet inspection
• Level III Level I Level II in-house QA
  testing to verify that material meets all
  specifications.

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Some Examples Used in a Small IVDMC

• In-House Produced Materials are All Treated as QA
  Level III
• QA Testing is performed to verify that the
  materials (antigens, antibodies, etc.) must meet
  specifications
• Only materials that meet specifications are
  retained for further manufacturing.

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Some Examples Used in a Small IVDMC

• Just as purchased materials are quarantined until
  accepted by QA, in-house manufactured materials
  are quarantined prior to use.

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Some Examples Used in a Small IVDMC

• Equipment reminders are handled by a calendar
  program
• MS Outlook works well
• Maintenance calibration are maintained in a
  computer log
• Equipment ID, last service date, next service
  date

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Business-Friendly Production Process Controls

• The objective of any business-friendly approach
  to PPC is
• To be the most cost effective in terms of time
  resources (in other words, to get it right the
  first time, every time)!

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Moving Forward

• Medical device companies will continue to compete
  for innovation, quality, and cost-effectiveness
• A business-friendly approach to production
  process controls achieves sustainable product
  quality and enhances the companys competitive
  edge