Design of a Quality Systems Program

possehastyΜηχανική

5 Νοε 2013 (πριν από 3 χρόνια και 9 μήνες)

62 εμφανίσεις


Design of a Quality Systems Program


meeting requirements now and in the future


Patricia (Pat) J. Griffin

April 2011


Quality Systems Program


Components and Structure


Interface between Quality System Components


Quality Design with Sustainability in mind


IT tools to enhance a Quality Systems Program






Quality Systems Program




Set of Quality Systems that include…


Corporate Policies


Standard Operating Procedures (SOPs)


Automation & Information Computer
Systems


Responsible People




Policies


Procedures


Who / What / How



Information and Automation Systems


Tools:

data management/process control


A part of the Quality System Program



Responsible People


Management


Monitors and Fosters continuous improvement


Employees


Accountable and Understands the “why”




Quality Systems Program



Leadership, QA Organization, Employee Readiness

Compliance Culture
-
People


Basic cGMPs & Policy


Quality Policy, Data Integrity Policy, etc.


Training
-

Proficiency

SOPs/Technical

Maintain

Track,
Trend,
Improve


Systems working
together day
-
to
-
day


Systems allowing
for continuous
improvement


Quality Systems Program


Key components



People


Responsibility, Accountability, Ownership


Applies across the organization


Every person with cGMP basics


Every person understanding their impact to
the whole process


No silos; Quality throughout


Quality Systems Program


The most important component



Production Systems depend on


Facilities, Engineering, Validation Systems


Deviation Management Systems


Lab Systems depend on


Incoming Material Systems and Production Systems


OOS Management Systems


Lot Release Systems depend on


Production and Lab Systems


Deviation and OOS Management Systems


Quality Systems Program


Interfaces/Dependencies



Training


Document/Records Management


Change Control


Deviation Management


Risk Management


Audit Processing (internal, supplier,
regulatory)


Product Recall


Quality Systems Program


The Core Systems



Level 3 Procedure
Level 3 Procedure
Level 2 Procedure
Level 3 Procedure
Level 3 Procedure
Level 2 Procedure
Level 3 Procedure
Level 3 Procedure
Level 2 Procedure
Level 1 Policy
Purpose of and elements of the Quality Program

Sequence of steps with process diagrams

Details the sequence of who, what, how


Quality Systems Program


Structure




Leads by Example


Steering Committee


Holds self and others accountable


Supports the QS program


Reviews Internal Trends and Gap
Assessments


Fosters continuous improvement


Recognizes/Reacts to business &
industry trends


Quality Systems Program


Management’s Role / Sustainability



Lack of Management Involvement


Inadequate communication


Inadequate issue resolution


Identify and address root cause quickly


Continuously improve processes



Low level of Employee Engagement


Get the best of the best engaged


Others will follow


Quality Systems Program


Potential Pitfalls



A
Part

of Quality Program


Ensure tools meet Quality Program design, not
other way around


Ensure they interface with other Automation/Info
tools if needed


Ensure system integrity exists (validate it)


Ensure people understand how to use the tools


Quality Systems Program


Automation/Information Systems



Replace or upgrade tools that …



Are not compatible or capable of compliance
with regulations


Are redundant


Don’t have capabilities to change as the
business changes


Can not offer trending to help identify areas
for improvement




Quality Systems Program


Automation/Information Systems



Know the regulations that apply


21CFR, Part 211, 211.68 (b)


21CFR, Part 11


Regulations are associated with specific
processes


e.g. 21 CFR 211.192


investigation handling


Ensure segregation of duty is maintained and
controlled





Quality Systems Program


Automation/Information Systems




Comprehensive Quality Program
-

a must


People
-

the most important component


Automation/Information Systems are tools



Design them for the Quality Systems Program


Ensure compliance with the right regulations


Include tracking/trending capabilities


Management involvement and Continuous
improvement
-

keys to sustainability


Quality Systems Program


Summary