CAPA for FDA regulated industries

Sunday
Business
Systems
The SBS Q-Med Database
Introduction
Features and Benefits
www.SundayBizSys.com
Fueling Small Business Efficiency
Corrective and Preventive Action software for FDA regulated industries

Sunday Business Systems
Background
Medical Device / FDA Quality standards require many things including:
 Corrective Actions
 Preventive Actions
 Nonconformance dispositions
 Internal Audits
 Management reviews
 Continual Improvement
 Customer satisfaction assessments
The SBS Q-Med database was created to ease the complexity of compliance
to quality management system standards:
 ISO 13485: Medical devices-Quality management systems-Requirements for
regulatory purposes
 Quality System Regulation 21 CFR 820

Q-Med Database Key Features
Nonconformance Tracking
 Escalate a Nonconformance to a Corrective Action
Corrective Actions (CA)
 Safety, Supplier, Internal Audit CARs
 With Validation and Verification
 Approvals require electronic signatures
Preventive Actions (PA)
Audit management
 Record audit findings
 Manage Audit Schedules
 Escalate to a Corrective Action or Preventive Action
Meeting management
Project management
Customer satisfaction surveys

Q-Med Modules
Non-Conformance
(NCR)
Corrective
Actions (CAR)
Preventive
Actions (PAR)
Customer
Complaint
Audits
Surveys
Quality Control
/ Inspection
Meeting
Manager
Improvement
Projects

User Interface
Username and Password protected
Efficient menu listing / “Switchboard”
Data entry in simple forms
A rich set of configurable reports
Email reports with a single click
Easily export data to Excel or Word

Analysis Tools
Wide variety of detailed reports
Charts, graphs, Pareto analysis
Quality performance metrics

General Features
Utilizes the 8D Corrective Action Process
Security with password access and control of privileges
CFR21 part 11 compliant security, Electronic signatures, audit trails
Link electronic documents for a paperless system
Supports single and Multi-user network environments
Built on Microsoft Access 2007
 Compatible with Microsoft Access 2010 and 2013
 No need to purchase Access if you do not have it
 A free run-time version of Access is available from the Microsoft
website

Benefits
Complies with requirements of
 21 CFR 820
 ISO 13485
 ISO 9001:2008
 CFR 21 part 11
Provides a concise, electronic record of historical events, actions, and
improvement
 No paper to get lost
Efficiently maintains quality records for
 Internal audits
 Corrective Action results
 Preventive Action results
 Management review or MRB meetings
 Nonconformances
 Customer satisfaction surveys
Improve product reliability and process performance
Improve Customer Satisfaction
 Rapidly report results to Customers
 Email report directly from the database
 Stay on top of key Customer issues
 Rebuild customer confidence when things go wrong
 Analyze Customer perceptions over time

Benefits
Efficient and cost effective
 Simple, low cost solution
 No additional software to purchase
 No annual maintenance fees
 Concurrent user licensing – not CPU based
 Minimal training is required
 Saves time and improves efficiency
Reports and analysis
 Managers get immediate answers
 How many CA/PA Requests are open and why?
 How long are CA/PA Requests open?
 Email reminders for open actions
Develop agendas for meetings
Easy to identify and manage open action items
Reduce cycle time to implement corrective actions

Login Screen
The login process limits access to the database features
The Demo version includes dummy data and employees
 administrator has full Database privileges
 For the demo database,
– Username: administrator
– Password: Aa777777
– Note: username and password are case sensitive

Sunday
Business
Systems
Corrective Action Requests
Background: The 8D problem solving process
CAR Form
Reports and analysis
Measure effectiveness

The 8D Problem Solving Process
D0 • Plan
D1 • Build a team
D2 • Define the problem
D3 • Contain the problem
D4 • Define and verify the root cause(s)
D5 • Determine and verify the permanent corrective actions
D6 • Implement and verify the permanent solution
D7 • Prevent recurrence
D8 • Congratulate the team!

Corrective Action Form
Form is organized
into 6 tabs
Yellow fields are
required fields
Purple fields
indicate Electronic
Signatures

CAPA Status (Process flow)
NEW CAR / PAR
Containment
Actions Approved
Proposed
Corrective Actions
Approved
CA have been
completed and
validated
Waiting
Containment
Containment
Approved
Corrective
Action
Approved
CLOSED
CAR / PAR is on
HOLD
CAR / PAR has
been CANCELLED
HOLD
CANCELLED
Process CAR / PAR Status
Exceptions Status

Corrective Action Form - Containment
Establish
containment actions
with specific owners
Electronic signature
required to approve
containment

Corrective Action Form – Root Cause Analysis
Document multiple root causes for a
single CAR including Primary, Escape,
and Contributing root causes
Ask why? Enough times to
determine effective root causes

Corrective Action Form – Corrective Actions
Electronic signature required
to approve Root
Cause/Corrective Action Plan
required to approve
validation
Establish clear,
quantifiable
acceptance criteria

Corrective Action Life Cycle

Corrective Action Form – Preventive Actions
required to approve
Preventive Action plan

Corrective Action Form – Comments and Attachments

Corrective Action Report
Print or email the CAR report directly to the Customer

Reports and Analysis
Rich set of reports including Pareto graphs and trend charts

Sunday
Business
Systems
Preventive Actions
PAR Form
Reports and analysis
Measure effectiveness
For want of a nail, the shoe was lost,
For want of the shoe, the horse was lost,
For want of the horse, the rider was lost,
For want of the rider, the battle was lost,
For want of the battle, the kingdom was lost,
And all for the want of a horseshoe nail!

PARs are handled nearly the same as CARs
Preventive Actions

PAR Reports

Sunday
Business
Systems
Nonconformance Tracking
Track non-conformances
Failure Analysis
Analyze defects for continual improvement
Escalate a Nonconformance to a CAR

Nonconformance Tracking
Enter General
Nonconformance details
Classify the
Nonconformances
based on the defect

Failure Analysis
Produce professional Failure
Analysis reports
Assign multiple root causes –
later, analyze by root cause
Describe the failure analysis
technique and results

Disposition Document what is to be done
with the material: Release,
Rework, Downgrade, or Scrap
Produce a concise
nonconformance report
Escalate any Non-
conformance to a CAR
with a click of a button
Electronic Signature
required to approve
Material Disposition

Actions associated with the NC

Nonconformance Analysis
Rich set of configurable reports and charts

Sunday
Business
Systems
Audit Management
Maintain audit schedules
Document audit findings
Convert findings into a CAR and / or PAR
Report and analyze results

Audit Details
Electronic Signature
required to approve and
close Audit

Audits Findings
Document detailed
audit findings
Create a CAR or PAR
Linked to the Audit with
a click of a button

Audit Conclusions
Summarize Strengths,
Weaknesses, and
overall Conclusions

Audit documentation
Add all supporting
documentation
(electronic files)

Audit Report

Manage Audit Schedule

Audit Reports and Analysis

Sunday
Business
Systems
Meeting Manager
Document meeting minutes
Track and manage actions
Drive Continual Improvement at the management level

Background
Great for MRB and Quality Management System Review meetings
Document a meeting
 Who attended
 What was the agenda?
 What was discussed?
 What were the resulting actions to be taken?
 Are the actions complete?
 Were the actions effective?

Meeting Details

Meeting Minutes

Actions and Validation

Supporting documents

Sunday
Business
Systems
Surveys
Create Customer Satisfaction surveys
Create Vendor Qualification surveys
Manage & analyze survey results

Simple Survey Features
Easily create custom surveys
Simple, intuitive interface
Print out or e-mail a professional looking survey directly
from the program
Ask different types of questions
 True or False / Yes or No
 Rating (on a scale of one to ten)
 Text response (let the customer provide feedback in his own
words)
Create an efficient quality record

Simple Survey Features
Customer Satisfaction
 Directly quantify customer satisfaction
 Monitor Customer perceptions
 Analyze trends with grafts and reports
Vendor qualification surveys
 Measure vendor suitability
 Monitor vendor improvement
Employee opinion polls
 Measure job satisfaction
 Solicit continual improvement ideas
 Measure and track long term results print

Create a Survey
Simple, efficient interface
Data entry in simple forms
Enter General
Information
Organize the
survey into topics
List all Survey
questions & define
types

Creating Surveys
Enter general survey information
Create a survey Category (i.e. Customer Service, General, Engineering Support, etc.)
Create a question and establish the order in which it will appear on the survey
Select the question type.
 Yes/no and true/false questions are rated as either 0 or 10
 Text response questions have no score
 Rating types receive a number rating from 1 to 10 with 1 being the lowest or worst level.
If the question was yes/no or true/false, you must determine if a positive answer
(yes or true ) carries the maximum score.
 Check the check box labeled "PositiveIsTen" if a positive answer receives the maximum
score.
 Leave the "PositiveIsTen" check box unchecked if a positive answer should receive the
minimum score.
Each question may be weighted differently (not all questions were created equal).
 The "Weight" field is used to score each question where Score = Rating * weight.
 The user must determine appropriate waiting factors.

Produce Professional Looking Surveys

Survey Analysis Tools
Variety of customizable reports
Charts, graphs

Sunday
Business
Systems
SBS Q-Med Database
Configuration and Installation

Demo Database Installation
The demo database is a stand-alone access database with all the features of
the standard product.
To install the program:
 Download the demo database from www.SundayBizSys.com
 Save or copy the Q-Med Database.accde file to a designated folder on your
Network File Server
 Ensure all Workstations have
 Microsoft Access or the free Runtime version of Microsoft Access
 Read and write privileges to the designated folder on the Network File Server
Note: The above graphic is for stand alone Access databases - SQL configurations are different

Purchased Product Installation
The purchased product has 2 parts:
 Microsoft SQL back end
 Microsoft Access front end
The Microsoft Access front end connects to the SQL back end through
standard ODBC links from each user computer.
The Customer must provide the SQL server and the database
administration. SBS will provide the SQL files for installation and the Q-Med
front end.

Sunday
Business
Systems
SBS Q-Med Database
Best in class software solution

Summary
The SBS Q-Med Database is a cost effective tool to
Ensure effective compliance with Quality standards
 ISO 13485
 21 CFR 820 - Quality System Regulation
 21 CFR Part 11
 ISO 9001:2008
Manage meetings
Monitor Customer perceptions
Maintain paperless quality records
Analyze performance and develop improvement strategies
Save time and effort

About SBS
Sunday Business Systems is engaged in software sales and consulting
services.
Sells affordable and efficient software solutions to implement Quality
management systems:
 Document Control
 Corrective and Preventive Actions
 Audit Management
 Employee Training
 Control of calibrated equipment
 Vendor Management
 SPC
 Continual improvement
Provides Training and instruction
Provides custom software solutions
 Modify and existing program
 Build a complete custom solution for your specific business processes
Sunday
Business
Systems

Sunday
Business
Systems
© 2014 Sunday Business Systems. All rights reserved. This presentation is for informational purposes only. Sunday
Business Systems MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY. Microsoft is a
registered trademark of Microsoft Corporation in the United States and/or other countries.
Fueling Small Business Efficiency
Visit www.SundayBizSys.com for:
•Additional information
•Free product demos
•Pricing
•Links to purchase software

CAPA for FDA regulated industries

More Related Content

What's hot

Similar to CAPA for FDA regulated industries

Recently uploaded

CAPA for FDA regulated industries

Editor's Notes