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Quality Database

Features and Benefits

www.SundayBizSys.comFueling Small Business Efficiency

www.SundayBizSys.com

Features

Corrective Actions (CA) Preventive Actions (PA) Internal Audit tracking Safety Corrective Actions Supplier Corrective Actions Quality Management System review

Document QMS review meetings and results

Continuous Improvement Tracking

CAPA = Corrective and Preventive Actions

•Team details•Problem Description•Containment•Corrective actions•Validation


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 No paper to get lost No files to shuffle

Complies with ISO 9001:2000 standard Maintains Quality records of

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)

Improves 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


Benefits

Efficient and cost effective Simple, low cost solution Little training required Saves time and improves efficiency

Managers get immediate answers How many CA/PA Requests are open and why? How long are CA/PA Requests open?

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. Assemble the team2. Define the problem3. Contain the problem 4. Diagnose the root cause 5. Identify solutions 6. Validate the solutions

• Implementation leads to permanent corrective actions

7. Prevent future / similar occurrences

8. Congratulate team


Corrective Action Process Flow

Employee / Manager CAR Team Management ReviewCustomer

Internal problemescalated to a CAR

Review ProblemDefinition /

Containment

Reports a Non-Conformance

1) Form Team2) Define The Problem3)Establish Containment

Containmentapproved?

Open a CAR inQuality DB

4) Diagnose Root Cause5) Identify Solutions

Review RootCause /

proposed CAs

8D approved?

6) Validate Solutions7) Define Preventive Actions

Revieweffectiveness of

Corrective /Preventive

Actions

Can theproblem re-

occur?

Present CAR to Customer

Close the CAR

Is CARresponseaccepted?

NO

YES

NO

YES

NONO Re-Open the

CAR and addressthe Customer's

concern

Corrective ActionComplete!

YES

Waiting forContainment

ContainmentApproved

8D Approved

ClosedCongratulate theTEAM!

YES

Safety IssueEscalated to a

CAR

Supplier Non-conformance

escalated to a CAR


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

Category User defined functional areas or departments

Status Automatically set based on the dates entered


CAPA Process Flow / Status

NEW CAR / PAR

ContainmentActions Approved

ProposedCorrective Actions

Approved

CA have beencompleted and

validated

WaitingContainment

ContainmentApproved

8DApproved

CLOSED

CAR / PAR is onHOLD

CAR / PAR hasbeen CANCELLED

HOLD

CANCELLED

ProcessProcess CAR / PAR StatusCAR / PAR Status

ExceptionsExceptions StatusStatus


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

Determine the Root Cause(s) May be multiple root causes

Primary root cause Escape Root cause Contributing root cause


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

Open Action

Not complete and/or not Validated

Action Status Description

Closed -Permanent

ActionPermanent

Action HAS been proven to work (has met or exceeded the validation Criteria)

Preventive Action Preventive

Action is preventative in nature (CAR may be closed with open

preventive measures)

CA HAS NOT been proven to work (must be proven to meet the

validation Criteria)

Detail

Closed -not

validated

Complete but invalid

Action HAS NOT been proven to work

(has failed the validation Criteria)


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 Validation / Acceptance Criteria Acutal Value P / F

Change Specification Rev 01 replaced by Rev 02Rev 02 released and distributed Pass

Train employees to rev 02 all production employees re-trainedTraining records audited and complete Pass

Purchase new tool visually observe new tool in use new tool in use PassMonitor gap measurement 98% < 15mm 100% < 15mm PassMonitor defect for 3 months Zero Re-occurances 1 defect observed 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?

Organized in 4 tabs QMS Details Data Review Actions and Validation Comments and files


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 Corrective and Preventive Actions Employee Training control of calibrated equipment Communication / Continual improvement

SBS also will customize the software for a particular Customer and train personnel as needed


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 [email protected]

Documents

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