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Quality Database
Features and Benefits

www.SundayBizSys.com Fueling Small Business Efficiency
Features
Corrective Actions (CA) Team details Problem Description Preventive Actions (PA) Containment Corrective actions Internal Audit tracking Validation Safety Corrective Actions Supplier Corrective Actions Quality Management System review
Document QMS review meetings and results
Continuous Improvement Tracking

CAPA = Corrective and Preventive Actions
www.SundayBizSys.com
Features

Simple, efficient interface Menu Driven Data entry in simple forms
Features

Wide variety of detailed reports Charts, graphs, Pareto analysis Reports Quality Performance metrics
Features
Link electronic documents, pictures, pdf files, Customer email Supports single Multi-user network environments 3 step set-up

Enter Company information Enter Company locations or sites Enter CAPA categories (i.e. functional groups within your organization)
Benefits
Provides a concise electronic record of historical events, actions, and improvement
Complies with ISO 9001:2000 standard
No paper to get lost No files to shuffle
Maintains Quality records of
Improves Customer Satisfaction

Management reviews (5.6.1) Internal audits (8.2.2) Corrective Action results (8.5.2) Preventive Action results (8.5.3) Supplier Corrective Actions (7.4.1)
Rapidly report results to Customers
Stay on top of key Customer issues Rebuild customer confidence when things go wrong
Email report directly from the database
Benefits
Efficient and cost effective

Simple, low cost solution Little training required Saves time and improves efficiency How many CA/PA Requests are open and why? How long are CA/PA Requests open?
Managers get immediate answers

Develops agendas for meetings Uses a proven method of Corrective Action Organizes and tracks actions from management review meetings
The 8D Problem Solving Process

1. 2. 3. 4. 5. 6.
Assemble the team Define the problem Contain the problem Diagnose the root cause Identify solutions Validate the solutions
7. 8.
Prevent future / similar occurrences Congratulate team

Implementation leads to permanent corrective actions
Corrective Action Process Flow

Customer Employee / Manager CAR Team Management Review
Safety Issue Escalated to a CAR Reports a NonConformance
Open a CAR in Quality DB Waiting for Containment Internal problem escalated to a CAR 1) Form Team 2) Define The Problem 3)Establish Containment Review Problem Definition / Containment
NO Supplier Nonconformance escalated to a CAR Containment Approved 4) Diagnose Root Cause 5) Identify Solutions
Containment approved?
YES NO
Review Root Cause / proposed CAs
8D Approved YES 6) Validate Solutions 7) Define Preventive Actions
8D approved?
YES
Is CAR response accepted?
Present CAR to Customer
Review effectiveness of Corrective / Preventive Actions
YES
Can the problem reoccur? NO Re-Open the CAR and address the Customer's concern
Corrective Action Complete!
NO
Close the CAR Congratulate the TEAM! Closed
Start a CAR organized into 4 tabs
CAR Details - (step 1 & 2)
Type
Internal External Customer Complaints Safety Internal Audit Supplier CAR issued to supplier
User defined functional areas or departments Automatically set based on the dates entered
Category
Status
CAPA Process Flow / Status

Process
NEW CAR / PAR
CAR / PAR Status

Waiting Containment
Exceptions
CAR / PAR is on HOLD
Containment Actions Approved Containment Approved
Status
HOLD
Proposed Corrective Actions Approved
8D Approved
CAR / PAR has been CANCELLED
CANCELLED
CA have been completed and validated
CLOSED
Containment and Root Cause - (step 3 & 4)
Containment and Root Cause
Contain the problem
Take immediate and possibly temporary actions to prevent the problem from happening today For example, Stop shipping and 100% inspect for the defect May be multiple root causes Primary root cause Escape Root cause Contributing root cause
Determine the Root Cause(s)
Actions and Validation (steps 5-7)
Corrective Actions
Each Action has an
Owner ECD Estimated Completion date First ECD original ECD (does not change) Current ECD may be changed Status see next Date complete enter after action has been validated Comment used to explain current status
Corrective Actions
Action Status Open Action Description
Not complete and/or not Validated
Detail
CA HAS NOT been proven to work (must be proven to meet the validation Criteria)
Closed Permanent Action Permanent
Action HAS been proven to work (has met or exceeded the validation Criteria)
Closed not validated
Complete but invalid
Action HAS NOT been proven to work (has failed the validation Criteria)
Preventive
Action
Preventive
Action is preventative in nature (CAR may be closed with open preventive measures)
Validation
Each action must be validated
Validation / Acceptance Criteria

Defines pass / fail criteria For example:
Pass99% measure < 15mm No re-occurance in 3 months Training records updated
Actual Value
Document the actual value observed Pass / Fail is recorded by changing the Action Status
Common Examples
Action
Acutal Value Rev 02 released and Change Specification Rev 01 replaced by Rev 02 distributed Training records audited and Train employees to rev 02 all production employees re-trained complete Purchase new tool visually observe new tool in use new tool in use Monitor gap measurement 98% < 15mm 100% < 15mm Monitor defect for 3 months Zero Re-occurances 1 defect observed
Validation / Acceptance Criteria
P/F Pass Pass Pass Pass Fail
Comments and Files
Add comments including customer feedback
Link electronic files such as pictures, customer emails, etc.
Preventive Actions
PARs use the same process and similar screens as CARs
QMS Reviews
Quality Management System Reviews
QMS Review
Document a QMS Meeting
Who attended? What was discussed? ISO9001:2000 establishes the basic agenda What were the resulting actions taken?
QMS Details Data Review Actions and Validation Comments and files
Organized in 4 tabs

QMS Details
QMS - Data review
QMS - Actions and Validation
QMS - Comments and Files
About SBS

Sunday Business Systems is engaged in software sales and consulting services. SBS sells software solutions to small businesses which help them implement ISO9001:2000 compliant systems for
SBS also will customize the software for a particular Customer and train personnel as needed
Corrective and Preventive Actions Employee Training control of calibrated equipment Communication / Continual improvement
About Us Consulting Services
Quality Systems Consulting
Building, training, and establishing ISO 9001:2000 compliant Quality systems.

gap analysis internal audits by RAB trained consultants process mapping, spec writing Quality Manual development Training Integrating software tools into an existing Quality Management System
About Us Consulting Services
Custom Database Solutions
solutions for shop floor control/order processing and bar code solutions. Database programming
MS Access SQL Delphi
If you are a consultant:

Contact us about our Reseller Program Sales@SundaybizSys.com


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Quality Database

Features and Benefits

Document QMS review meetings and results

Continuous Improvement Tracking

Simple, efficient interface Menu Driven Data entry in simple forms

Provides a concise electronic record of historical events, actions, and improvement

Complies with ISO 9001:2000 standard

No paper to get lost No files to shuffle

Maintains Quality records of

Improves Customer Satisfaction

Rapidly report results to Customers

Email report directly from the database

Efficient and cost effective

Managers get immediate answers

The 8D Problem Solving Process

Prevent future / similar occurrences Congratulate team

Implementation leads to permanent corrective actions

Corrective Action Process Flow

Safety Issue Escalated to a CAR Reports a NonConformance

Review Root Cause / proposed CAs

8D Approved YES 6) Validate Solutions 7) Define Preventive Actions

Is CAR response accepted?

Present CAR to Customer

Review effectiveness of Corrective / Preventive Actions

Corrective Action Complete!

Close the CAR Congratulate the TEAM! Closed

Start a CAR organized into 4 tabs

CAR Details - (step 1 & 2)

CAPA Process Flow / Status

CAR / PAR Status

Proposed Corrective Actions Approved

CAR / PAR has been CANCELLED

CA have been completed and validated

Containment and Root Cause - (step 3 & 4)

Containment and Root Cause

Contain the problem

Determine the Root Cause(s)

Actions and Validation (steps 5-7)

Each Action has an

Closed Permanent Action Permanent

Closed not validated

Complete but invalid

Each action must be validated

Validation / Acceptance Criteria

Pass99% measure < 15mm No re-occurance in 3 months Training records updated

Validation / Acceptance Criteria

P/F Pass Pass Pass Pass Fail

Comments and Files

Add comments including customer feedback

Link electronic files such as pictures, customer emails, etc.

Document a QMS Meeting

QMS - Data review

QMS - Actions and Validation

QMS - Comments and Files

About Us Consulting Services

Quality Systems Consulting

Building, training, and establishing ISO 9001:2000 compliant Quality systems.

About Us Consulting Services

Custom Database Solutions

If you are a consultant:

Contact us about our Reseller Program Sales@SundaybizSys.com

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