corrective and preventive actions using the quality database

Sunday Business Systems

The Quality Database

Features and BenefitsIntroduction and Tutorial

www.SundayBizSys.comFueling Small Business Efficiency

Sunday Business Systemswww.SundayBizSys.com

Features

Nonconformance Tracking Corrective Actions (CA)

Safety Corrective Actions Supplier Corrective Actions Internal Audit Corrective Actions

Preventive Actions (PA) Internal Audit Management

Record an track audit findings Manage Audit Schedules

Document management review meetings Continuous Improvement Tracking Customer Satisfaction Surveys

CAPA = Corrective and Preventive Actions


User Interface

Simple, efficient interface Menu driven Data entry in simple forms A rich set of configurable reports Email reports with a click


Analysis Tools

Wide variety of detailed reports Charts, graphs, Pareto analysis Quality Performance metrics


Features

Control user access levels Link electronic documents, pictures, pdf files, Customer email Supports single and Multi-user network environments Built on Microsoft Access 2003

A free version of Access is included with the full download No need to purchase Access if you do not have it Run on Microsoft Access 2007 and 2010

Simple set-up Enter employee names, passwords, and access levels Enter Company information Enter Company locations or sites Enter CAPA categories (i.e. functional groups within your

organization) Enter Nonconformance defect categories Enter list of root cause categories


Benefits

Complies with requirements of ISO 9001:2008 AS9100 ISO / TS 16949

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

No paper to get lost No files to shuffle

Maintains Quality records of ISO 9001:2008 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) Customer satisfaction surveys (8.2.1)

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 Analyze Customer perceptions and how they change 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

Little training required Saves time and improves efficiency

Managers get immediate answers Save time with instant analysis How many CA/PA Requests are open and why? How long are CA/PA Requests open?

Develop agendas for meetings Utilizes a proven method of Corrective Action Organize and track actions from management review meetings


Database Set-up and Configuration

Add Employee informationSet user passwords and access levels Customize set-up parameters


Login Screen

The login process limits access to the database features The Demo version includes dummy data and employees

Admin is the default login for demo versions (unregistered) Admin has full Database privileges

Employee: Admin Password: admin All other employees password = pw


Setting up the Database

Add Employees (owners) Enter Company specific information

Company contact information Sites Categories /departments Root Cause categories Defect categories Customer List Supplier Lists Parts List Document names


Add / Edit Employees

Employees are your CAR, PAR, NC owners Used for automatic emails

A password must be entered for a user to log

in

Defines standard privileges

Specific privileges may also be selected


Set-Up Parameters

Organized into one form with multiple tabs


Corrective Action Requests

Background: The 8D problem solving processCreate a CARReview reportsMeasure effectiveness


Types of Corrective Action Requests

Internal Originated from within the company

External Originated from outside source like a regulatory body or potential

Customer Customer complaint

Defective product shipped to Customer Late delivery

Internal Audit Internal audit findings

Safety Results of Safety audit Safety incident investigation OSHA compliance

Supplier Vendor or supplier failing to perform to specification Late deliveries, defective parts


The 8D Problem Solving Process

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

• Verify solutions are effective6. Validate the solutions

• Ensure implementation leads to permanent corrective actions

7. Prevent future, similar occurrences8. Congratulate the 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 5 tabs

Yellow fields indicate required

parameters


Tab #1: CAR Details - (8D steps 1 & 2)

CAR Type Internal External Customer Complaints Safety – for OSHA compliance Internal Audit Supplier CAR – issued to supplier

Category User defined functional areas or departments

Status Automatically set based on the dates entered

Dates Determine the status of the CAR

Details (Part #, PO, etc.)

Define the CAR team Detailed Problem description


CAPA Process Flow / Status

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 onHOLD

CAR / PAR hasbeen CANCELLED

HOLD

CANCELLED

ProcessProcess CAR / PAR StatusCAR / PAR Status

ExceptionsExceptions StatusStatus


Establish containment actions with

specific owners

Tab #2: Containment and Root Cause - (8D steps 3 & 4)

Document multiple root causes for a

single CAR


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 have multiple root causes

Primary root cause Escape Root cause Contributing root cause

Corrective actions must be aligned to each root cause


Tab #3: Corrective Actions and Validation – (8d

steps 5-7)

Establish corrective actions with

specific owners

Establish Validation criteria and

document closure


Corrective Actions

Record multiple Corrective Actions for each CAR Management or designate may verify each action to ensure they

Effectively address each root cause Ensure the problem will not re-occur

Each Action has an Owner ECD – Estimated Completion date

First ECD – original ECD (does not change) Current ECD – may be changed

Status – see corrective Action Life Cycle Date complete Comment – used to explain current status Validation or acceptance criteria Validation name and date

Once reviewed and approved, the Corrective Action plan is considered “Approved”


Corrective Action Life Cycle


Verification and Validation

Verification Documented by approving the corrective action plan Should require management review and approval

Each action must be validated Validation / Acceptance Criteria

Defines pass / fail criteria For example:

– 99% of all parts measure < 15mm– Document XX version 02 released on 4-May-2006– Training records updated

Actual Value Document the actual value observed Pass / Fail is recorded by changing the Action Status


Examples of Actions with Validation

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


Tab #4: Preventive Actions

Document any preventive actions to prevent similar occurances


Tab #5: Comments and Files

Add comments including customer feedback

Link electronic files such as pictures, customer emails,

etc.

Email the electronic CAR report directly to Management or

Customers


Professional Reports

Print or email the CAR report directly to the Customer


Handy Features

Tool Bars Sort Filter forms Search for data Export data Spell check

Directory


Preventive Actions

PARs use the same process and similar forms as CARs

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

PAR


PAR Reports

Measure PAR effectiveness Rich set of PAR reports


Nonconformance Tracking

Track non-conformancesProduce Failure Analysis reportsAnalyze defects for continual improvement


Nonconformance Tracking

Enter General Nonconformance details

Analyze Nonconformances based on the defect category


Failure Analysis Perform Failure Analysis

Assign multiple root causes – later, analyze

by root cause

Produce professional Failure Analysis reports


Disposition Document what is to be done with the material: Release, Return, or scrap

Produce a concise nonconformance report

Escalate any Non-conformance to a CAR with a click of a button


Nonconformance Analysis

Rich set of configurable reports and charts


Internal Audit Management

Schedule AuditsDocument audit findingsConvert findings into a CAR and / or PAR


Internal Audits

Document general audit details

Enter dates; an audit is open if

there is no completion date

Generate audit reports


Internal Audits

Document detailed audit findings

Create a CAR or PAR from the Audit with a click of a button


Manage Audit Schedule


Internal Audit CARs


Analysis and Reporting

Simple and effective reportingMeasures the health of your CAPA systemHelps identify opportunities for improvement


Reports and Analysis

Graphs and charts Extensive Reports Email reports with a click of a button

Automatically email all CAR owners Export data to Excel or Word


Management ReviewsQuality Management System ReviewsDocument meeting minutesTrack and manage actions Drive Continual Improvement at the management level


QMS Review

Document a QMS Meeting Who attended? What was discussed?

ISO9001:2008 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


Simple Surveys

Create Customer Satisfaction surveysCreate Vendor Qualification surveysManage & 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


User Interface

Simple, efficient interface Menu Driven 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


Summary

The SBS Quality Database is a cost effective tool to Ensure effective training compliance with

ISO 9001:2008 AS 9100 TS 16949 OHSAS 18001 ISO 14001

Manage Corrective and Preventive Actions Manage Management Review 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.

Applies Lean Manufacturing principles to Quality Management Systems

Sells affordable and efficient software solutions to help implement ISO9001:2008 compliant systems

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

Provides Training and instruction Will customize the software for specific Customer needs

We build a custom solution for your specific business processes


© 2007 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 EfficiencyFueling Small Business Efficiency

Visit www.SundayBizSys.com for:•Additional information•Free product demos•Pricing•Links to purchase software

corrective and preventive actions using the quality database

Business

comsunday business systems

permanent corrective

corrective action results

customer email

track actions

customer confidence

customer perceptions

microsoft access