Common Industry Mistakes and How to Avoid Them

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Common Industry Mistakes and How to Avoid Them

• Susan C. Reilly
• Reilly Associates, LLC
• SReilly_at_ReillyandAssociates.com
• 617-899-2319

FDA Update December 2008
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Common Mistakes

• QMS links not recognized or identified
• Weak internal audit program
• CAPA poorly executed

• Lack of or poorly written procedure
• Inadequate training
• Competing resources
• Complex processes
• Timeliness
• Reliance on software
• Inconsistency across global companies

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QMS Links

• Clearly identify and understand process inputs
  and outputs
• Process mapping
• Allows QMS work as a system
• Cannot effectively function if each process
  remains an independent element

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Internal Audits

• Too many companies perform audits just because
  they have to?
• Audits can, and need to be, value added

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CAPA

• CAPA links to all other QMS activities
• Consider what is relevant to your business
• Product type and complexity
• Manufacturing process and complexity
• Volume of product manufactured
• Monitor data sources relative to the risks
  associated with failure

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Procedures

• Read the regulation
• Write to the audience that will be using the
  document
• Less words, more process maps, tables, flow
  charts, pictures

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Training

• Employees at all levels require training against
  company specific systems
• Cannot always rely on self training
• Training effectiveness must be monitored for
  process improvements

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Records

• Records / files do not reflect the current status
  or level of work performed
• Documentation rules forward and backward
  traceability
• It all needs to be there AS it is being done!

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Competing Resources

• More work - fewer resources
• The quality system is not Qualitys job
• Conflicting or changing priorities
• Avoid competing for the same resources by
  aligning QMS goals with CAPA with business
  objectives

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Process Complexity

• Process complexity impedes ability to act
  appropriately
• Unnecessary approvals and signatures
• Software is driving the process
• Poor use of committees
• Multiple systems adding to complexity
• Everything carries the same weight

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Timeliness

• What is timely? What is closed? What is
  pending?
• Define criteria for closure, dont bind yourself
  with unrealistic time frames
• Build in means for management escalation

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Misuse of Software

• Automation is a tool not a solution
• Define your process first, then choose software
  that best works with your your process

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Global Companies

• Must overcome perceptions business, methods,
  terminology, cultures, etc. are different or
  unique
• Opportunities exist to consider similar issues
  across multiple facilities
• Share product, process and quality system
  information from various locations, sister
  facilities, manufacturing plants, to emphasize
  both problems and solutions

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Summary
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Questions
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Thank You!
Susan C. Reilly Reilly Associates 50 Old Quarry
Road Wrentham, MA 02093 617-899-2319 SReilly_at_Reil
lyandAssociates.com
Feel free to call or email with any questions
concerning the presentation