Preventive Action, Correction, and Corrective Action: From

63 Pages·2009·0.22 MB·English

Preventive Action, Correction, and Corrective Action:
From Requirements to Effective Processes
s
e
s
i
r
p
r
e
t
n
E
BosCon 2009

u Waltham, MA
b
m April 28, 2009
O
Dan O’Leary CQE, CRE, CSSBB, CIRM
Ombu Enterprises, LLC
[email protected]
CAPA - Requirements to Process 1
Introduction
• Dan O’Leary
– Dan has more than 30 years experience in quality, operations,
and program management in regulated industries including
s aviation, defense, medical devices, and clinical labs. He has a
e
Masters Degree in Mathematics; is an ASQ certified
s
i
r Biomedical Auditor, Quality Engineer, Reliability Engineer,
p
r and Six Sigma Black Belt; and is certified by APICS in
e
t Resource Management.
n
E
• Ombu Enterprises, LLC

u
b – Ombu works with small manufacturing companies, offering
m
training and execution in Operational Excellence. Focusing on
O
the analytic skills and systems approach of operations
management, Ombu helps companies achieve efficient,
effective process and regulatory compliance.
CAPA - Requirements to Process 2
s
Outline
e
s
i
r
p
r
e
t
n
E
Our Perspective

u
b
m The Topics We Will Cover
O
CAPA - Requirements to Process 3
The Problem
• The contrast of technical terms can confuse:
– Preventive Action (cid:217) Corrective Action
– Correction (cid:217) Corrective Action
s
e
s – Repair (cid:217) Rework
i
r
p
– Nonconformity (cid:217) Defect
r
e
t
n • The technical dictionary is essential
E

– ISO 9000:2005 contains the dictionary, but not
u
b
many people look at it
m
O
• The FDA, with QSR, didn’t define many of
these terms, and seems to confuse some of
them.
CAPA - Requirements to Process 4
The Problem (cont.)
Fred: We just had a rejected lot of the new model of framitz.
We will fix them, so they will be OK to ship, but I’d like to
prevent this problem from happening again.
s
e
s
i Jane: Thanks for letting me know. Don’t forget to document
r
p
r your work in the CAPA process.
e
t
n
E

u
b
m
Question: When we “fix the framitz”, what technical term
O
applies?
Question: When Fred “prevents the problem from happening
again” is he taking Corrective Action or Preventive Action?
CAPA - Requirements to Process 5
Our Approach
• We will look at the formal definitions
– Introduce the concept diagrams from ISO
s
9000:2005
e
s
i
r
p • Use examples to help clarify the
r
e
t differences
n
E

u
• Use our knowledge to extract the
b
m
O process from the requirements
• Build and measure our process
CAPA - Requirements to Process 6
Outline
• We look at three standards . . .
– ISO 9001:2008
– ISO 13485:2003
s
e
s – QSR (21 CFR Part 820)
i
r
p
• and bring forward the associated definitions
r
e
t
n – ISO 9000:2005
E

– QSR (21 CFR Part 820)
u
b
m • We analyze the requirements
O
• We define and characterize metrics
• We design and implement processes
CAPA - Requirements to Process 7
s
ISO 9000:2005
e
s
i
r
p
r
e
t
n
E
Definitions

u
b
m Concept Diagrams
O
CAPA - Requirements to Process 8
Definitions
• ISO 9000:2005 groups concepts
– They are not listed alphabetically as in a
s standard dictionary
e
s
– The groupings use concept diagrams
i
r
p
r
e • The definitions capture the essential
t
n
E characteristics of the concept

u
b
• In theory, if a term is substituted by its
m
O
definition, the text will not change
meaning
CAPA - Requirements to Process 9
Concept Diagram for Conformity (3.6)
requirement
defect nonconformity conformity
s
e
s
i
r
p
r
e
t preventive corrective correction scrap
n
E action action

u
b
m
Note: This is
O
rework regrade only a portion
of the diagram.
repair
CAPA - Requirements to Process 10