Presented Lean and Compliant Quality Management Reviews, Dec 2, 2009

1. Lean & Compliant
Quality Management Reviews
Rich Laguna,
Quality Assurance Consultant A process approach to lean & compliant
lagunar@sbcglobal.net Quality Management Reviews

2. Topics of discussion
• Lean, compliant, process approach – understanding of terms
• A Quality Management Review process model
• Identify lean opportunities
• Evolution of a Quality Management System
• Compliance – FDA 483s/warning letters
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 2

3. Initial Thoughts…
Compliant Quality Management Reviews
~ Quality System Regulation - 21CFR 820.20(c) Management Review
~ ISO 13485:2003 - 5.6 Management review
~ Determine suitability, adequacy & effectiveness of the QMS
Lean Quality Management Reviews
~ How can lean principles be applied?
~ Understanding of lean processes.
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 3

4. Quality Management Review
Process Approach Defined
Lean Quality Management Reviews
~ How can lean principles be applied?
~ Understanding of lean processes.
Definition:
“Any activity that receives inputs and converts them to outputs can be
considered as a process.”
“The application of a system of processes within an organization,
together with the identification and interactions of these processes,
and their management, can be referred to as the “process approach.”
Quoted: ISO 13485:2003 (0.2) Process approach
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 4

5. Quality Management Review
Process Control System Model
Voice of the process • Attendance record
• Agenda
• Presentation
• Meeting Minutes
People
Blending of resources / Customers
QMS QMR Meeting
QMR Development (internal/external)
Stds & Regs
Identify changing
Needs & expectations
Inputs Process / System Outputs
Voice of the customer
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 5

6. Identify LEAN Opportunities
Voice of the process • Attendance record
• Agenda
IES
• Presentation
• Meeting Minutes
Blending of resourcesNIT
People
TU QMR Meeting
/ Customers
OR
QMS
QMR Development (internal/external)
PP
Stds & Regs
NO
LEA
Identify changing
Needs & expectations
Inputs Process / System Outputs
Voice of the customer
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 6

7. Lean Quality Management System Concept
Eliminate / Reduce Non-Value Added Activities (NVA)
FOCUS: Efficiency & Compliance
Identify waste
• Excessive layers of procedures and forms (policy Vs process)
– Consolidate were appropriate.
• Top down approach to signature approvals
– Realign approval signatures to individuals with direct responsibility.
• Conflicting requirements within the QMS
– Align requirements and only state a requirement once.
• Stagnant MS Word forms – poor data collection methods
– Appropriate database solutions (Enterprise Quality Management
System or Hybrid System). Capture data once, query the data,
generate predefined metrics, report into Management Reviews.
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 7

8. Evolution of the Quality Management System
finding a balance
• Information (metrics) presented and frequency of Management Reviews are
influenced by the Company Life Cycle and the evolution of the QMS.
Annually Bi-Annually Quarterly
Voice of Customer &
QMS Evolution
Process of QMS
(Risk)
EQMS
Hybrid
ed p th ed n re it
Se -u sh sio tu Ex
rt ow i an a
St
a Gr bl M
ta xp
Es E
Company Life Cycle
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 8

9. Compliant
Quality Management Reviews
Compliant Quality Management Reviews
~ Quality System Regulation - 21CFR 820.20(c) Management Review
~ ISO 13485:2003 - 5.6 Management review
~ Determine suitability, adequacy & effectiveness of the QMS
FDA 483s / Warning Letters:
1. Failure of management with executive responsibility to effectively establish
and maintain quality system requirements, as required by 21 CFR
820.20(b)(3)(i). For example:
“Management review failed to identify inadequate or missing aspects of the quality system
requirements, such as inadequate SOPS, inadequate training of employees, inadequate record
keeping, inadequate quality audits, lack of design controls and failure to adequately validate
processes and equipment.”
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 9

10. Compliant
Quality Management Reviews
Compliant Quality Management Reviews
~ Quality System Regulation - 21CFR 820.20(c) Management Review
~ ISO 13485:2003 - 5.6 Management review
~ Determine suitability, adequacy & effectiveness of the QMS
FDA 483s / Warning Letters cont.
2. Failure of management with executive responsibility to review the suitability and
effectiveness of the quality system at defined intervals and with sufficient frequency
according to established procedures, as required by 21 CFR 820.20(c).
FDA Inspections
In recent FDA inspections, the agency has asked to see the Management Review
presentation deck. Does your company have a plan to handle this request?
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 10

11. Compliant
Quality Management Reviews
Agenda Quality Assurance Review
oComplaints
Purpose oInternal Audits
Quality Policy Review oCAPA
Quality Plan & Objectives oNon-Conforming Material
oSupplier Management
Human/IT/Facility Resources
oDocument Change Mgmt
Manufacturing Review
Quality System Changes
Engineering & Field Service
QMS Management Review output
Clinical & Regulatory Affairs
o New/revised regulatory QMS Compliance Statement
requirements Action Items
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 11

12. Compliant
Legend
Quality Management Reviews On track
Careful watch
Action required
System System
Quality System Corrective/Preventive Action
Documentation Effectiveness
1. Quality management system
General requirements Yellow – State monitoring plan plan
Yellow – State monitoring
Documentation requirements G Y
Red – CAPA plan
Red – CAPA Plan
2. Management Responsibility
Management commitment
Customer focus
G R
Planning
Responsibility, authority, com
Management review
3. Resource Management
Provision of resources
Human resources
G Y
Infrastructure
Work environment
4. Product Realization… G G
5. Measurement, analysis, and
improvement… G G
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 12

13. Compliant
Quality Management Reviews
Compliance Statements
Fully Implemented QMS
• The [company name] Quality Management System continues to be suitable
and effective with the identified Quality Plan, goals, and resource needs.
Start-Up QMS (pre-commercialization)
• The [company name] Quality Management System (QMS) continues to
evolve into a fully implemented system. The Management Review has
identified sub-processes status, implementation, and monitoring plans.
Therefore, the QMS is found to be suitable and effective with the Quality
Plan, goals, and resource needs.
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 13

14. Summary
Lean & Compliant Quality Management Reviews
LEAN:
• Consider the entire Quality Management Review process for lean opportunities.
– Reduce the time it takes to produce the Management Review meetings. Implement
efficient data collection and reporting methods.
– Align the frequency with the Company Life Cycle.
– Be aware of “analysis paralysis”. Present information only necessary to make decisions.
COMPLIANT:
• Present the “tough” information to make CAPA decisions.
• Information presented is sufficient to determine the suitability, adequacy, and
effectiveness of the entire QMS.
• Align to the QSR & ISO 13485:2003 (5.6) Review Input, Review Output.
– Say what you do (procedures), Do what you say (execution)
• Close loop process.
– i.e., Management Review documentation should be reviewed to determine if the
process failed to identify field action decisions.
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 14

15. Summary cont.
Lean & Compliant Quality Management Reviews
LEAN & COMPLIANT
QUALITY MANAGEMENT REVIEW PROCESS
Thank you!
Rich Laguna,
Quality Assurance Consultant
lagunar@sbcglobal.net
Rich Laguna, Quality Assurance Consultant
(lagunar@sbcglobal.net) 15