Corrective Actions and Risk management for ISO 9001:2015

The Quality Database
Features and Benefits
Introduction and Tutorial
www.SundayBizSys.com
Fueling Small Business Efficiency

Sunday Business Systemswww.SundayBizSys.com
Background
Quality management standards require many things, including
 Corrective and Preventive Actions
 Internal Audits
 Management reviews
 ISO 9001:2015 “The Organization shall continually improve the effectiveness of
the quality management system through the use of…audit results, analysis of
data, corrective and preventive actions, and management review.”
The SBS Quality database was created to ease the complexity of compliance
to quality management standards
 ISO 9001
 AS9100
 ISO/TS 19649
 ISO 13485

Features
Nonconformance Tracking
Corrective Actions (CA)
 Safety Corrective Actions
 Supplier Corrective Actions
 Internal Audit Corrective Actions
Preventive Actions (PA)
Risk Management (FMEA)
Internal Audit Management
 Record and track audit findings
 Manage Audit Schedules
Document management review meetings
Manage continuous improvement projects
Customer Satisfaction Surveys
CAPA = Corrective and Preventive Actions

User Interface
Simple, efficient interface
 All modules clearly displayed
 Quick Navigation ribbon
Data entry in simple forms
Easy data analysis
 A rich set of configurable reports
 Email reports with a single click
 Export data to excel, word, or PDF

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

Features
User login - Controls access to designated modules
Link electronic documents, pictures, pdf files, Customer email
Supports single and Multi-user network environments
Built on Microsoft Access 2007
 A free runtime version of Access is available from Microsoft
 No need to purchase Access if you do not have it
 Compatible with Microsoft Access 2010, 2013 and 2016
Simple set-up
 Enter employee names, passwords, and access levels
 Enter Company information
 Enter Company locations or sites and departments
 Enter CAPA categories (i.e. functional groups within your
organization)
 Enter Nonconformance defect categories
 Enter list of root cause categories
 Start using the program!!!

Benefits
Complies with requirements of
 ISO 9001:2015
 AS9100
 ISO/TS 16949
 ISO 13485
 API Q1
Provides a concise electronic record of historical events, actions, and
improvement
 No paper to get lost
 No files to shuffle
Efficiently maintains quality records
 Management reviews
 Internal audits
 Corrective Action results
 Risk management results
 Supplier Corrective Actions
 Customer satisfaction surveys
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
 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
Utilizes a proven method of Corrective Action
Organize and track actions from management review meetings

Database Set-up and Configuration
Add Employee information
Set user passwords and access levels
Customize set-up parameters

Easy Installation
Download the demo database
Save or copy the Quality DB.accde file to a designated folder on your
Network File Server
Once purchased, register the demo database (enter the Product Code)
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

Login Screen
The login process limits access to the database modules
The Demo version includes example data that may be modified
 Admin is the default login for demo versions (unregistered)
 Admin has full Database privileges
 For the demo database,
– Employee: Admin
– Password: admin
– All other employees password = pw

Setting up the Database
Add Employees (owners)
Company contact information
Build drop-down lists
 Sites
 Departments
 CAR/PAR Categories
 Root Cause categories
 Defect categories
 Customer List
 Supplier Lists
 Parts List
 Document names
 FMEA parameters

Add / Edit Employees and Assign Privileges
Employees are your CAR, PAR, NC owners and action owners
Note: Yellow fields are required
Used for automatic emails
Enter a password to log in
to the database
(Must be les than 16
characters long)
Access Level defines
standard privileges
Specific privileges may
also be selected

Set-Up Parameters
Organized into one form with multiple tabs
Many tabs contain information used to build drop-down lists on various
forms for example
 Parts, Customers, Suppliers, etc.

Set-up Parameters

Set-Up Parameters

Set-Up Parameters – Document Details
Document #s appear on key forms
 to trace forms to your document control system

Corrective Action Requests
Background: The 8D problem solving process
Create a CAR
Review reports
Measure 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
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 Process Flow
Employee / Manager CAR Team Management ReviewCustomer
Internal problem
escalated to a CAR
Review Problem
Definition /
Containment
Reports a Non-
Conformance
1) Form Team
2) Define The Problem
3)Establish Containment
Containment
approved?
Open a CAR in
Quality DB
4) Diagnose Root Cause
5) Identify Solutions
Review Root
Cause /
proposed CAs
8D approved?
6) Validate Solutions
7) Define Preventive Actions
Review
effectiveness of
Corrective /
Preventive
Actions
Can the
problem re-
occur?
Present CAR to Customer
Close the CAR
Is CAR
response
accepted?
NO
YES
NO
YES
NO
NO Re-Open the
CAR and address
the Customer's
concern
Corrective Action
Complete!
YES
Waiting for
Containment
Containment
Approved
8D Approved
ClosedCongratulate the
TEAM!
YES
Safety Issue
Escalated to a
CAR
Supplier Non-
conformance
escalated to a CAR

Corrective Actions – organized into 5 tabs
Use filters to display a
limited set of data
Yellow fields are
required
Double click blue to
jump to part list

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 – clearly define the problem

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 on
HOLD
CAR / PAR has
been CANCELLED
HOLD
CANCELLED
Process CAR / PAR Status
Exceptions Status

Tab #2: Containment
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
 Definition: ECD = Estimated Completion Date or due date
Establish
containment actions
with specific owners

Tab #3: Root Cause Analysis
Determine the Root Cause (s)
 Document the 5 Why’s
 The problem may have multiple root causes
 Primary root cause
 Escape Root cause
 Contributing root cause
Corrective actions must be aligned to each root cause
Document multiple root causes for a
single CAR including Primary, Escape,
and contributing root causes
Ask why?, why?, why?, why?, why? to
determine effective corrective actions

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

Tab #4: Corrective Actions and Validation
Establish corrective
actions with specific
owners
Establish Validation
criteria and
document closure

Corrective Action Life CycleAction Life Cycle
Process Action Status
Create New Action
Item
Begin work on
closing action item
Complete Action
item
Action no longer
needed?
Cancel Action Item
Validate results of
Action
Meet or exceed
Acceptance Criteria?
Action was
successfully
completed
Action was
completed but not
effective
No
YES
YES
NO
Open
Complete;
Validation
Needed
Complete;
Permanent
Complete;
Invalid
Cancelled

Verification and Validation
Verification
Documented by approving the corrective action plan
Should require management review and approval
Upon completion, 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 and reviewed
Actual Value
 the observed or actual value
Record who validated the action, when, and definitively state that the
action was effective (or not)

Examples of Actions with Validation
Action Validation / Acceptance Criteria Acutal Value P / F
Change Specification Rev 01 replaced by Rev 02
Rev 02 released and
distributed Pass
Train employees to rev 02 all production employees re-trained
Training records audited and
complete Pass
Purchase new tool visually observe new tool in use new tool in use Pass
Monitor gap measurement 98% < 15mm 100% < 15mm Pass
Monitor defect for 3
months Zero Re-occurances 1 defect observed Fail

Tab #5: Preventive Actions
Document any actions to prevent similar occurrences

Tab #6: Comments and Files
Add comments including
customer feedback
Link any number of
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
Forms may be
 Sorted
 Filtered
 Searched
 Export data
 Spell check
Directory
 Lists a summary

CAR Reports
A full set of reports, charts, graphs and analysis
Apply filters to reports

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

Nonconformance Management
Track non-conformances
Document product disposition
Perform Failure Analysis
Analyze defects for continual improvement

Nonconformance Management
Enter General
Nonconformance details
Classify the
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 Audits
Schedule audits
Document audit findings
Convert findings into a CAR and / or PAR
Report and analyze results

Internal Audits
Generate audit
reports
Document general
audit details
Enter dates; an audit
is “open” if there is no
completion date

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

Manage Audit Schedule
To schedule an audit in
the future: 1) enter
the audit details
2) Click button to
schedule audit
Review the entire audit
schedule

Internal Audit CARs
Once Audit Findings have been escalated to a Corrective Action Request,
they may be managed in the CAR Module
Click to view the IA CAR

Audit Reports and Analysis

Risk Management
FMEA
SWOT Analysis

Risk Management Overview
The Quality Database incorporates 2 risk management techniques
 SWOT analysis (Strengths Weaknesses Opportunities and Threats)
 FMEA (Failure Modes and Effects Analysis)
For compliance, we recommend
 Using SWOT analysis for upper level business risk analysis
 Competitive advantages
 Threats to overall business
 Market analysis
 Using FMEA analysis for detailed product and process risk management
 Product Design FMEA
 Manufacturing operations (process) FMEA
These two risk management techniques can be optimally applied to different
levels of organizational risk management

Overall Risk Management Strategy
SWOT Analysis FMEA
Sales / Marketing
Strategy
Project
Planning
Product Design
Manufacturing
Process
Manufacturing
Process Design
Corporate Vision
Competitive Analysis

FMEA
FMEA Background
Features and Benefits
Set-up and Use

History
FMEA: Failure Mode and Effects Analysis
Was one of the first systematic techniques for failure analysis
Developed by reliability engineers in the 1950s to study problems that may
arise from military system malfunctions
Further developed and adopted by the aerospace and automotive industries
Today, it is a standard technique for risk analysis and continual
improvement

FMEA
An FMEA is often the first step of a system reliability study.
It involves reviewing as many components, assemblies, and subsystems as
possible to identify failure modes, and their causes and effects.
FMEA begins during the earliest stages of design and continues throughout
the life of the product or service.
You can use the FMEA Tool in two separate, but related ways:
 Analyze the current process and evaluate the potential impact of changes under
consideration
 Track improvement over time

Reduce Risk and Improve Performance
The FMEA is a simple business process:
 Anticipate: what can go wrong?
 Prioritize actions to
 Reduce the severity or impact of an adverse event
 Decrease the frequency of an adverse event
 Increase the delectability of an adverse event
 Complete the actions in a timely fashion
 Re-evaluate the process / product / service in light of
 New data
 Improved processes
 New processes

FMEA Process Flow
Complete Actions and
Re-compute RPN
Determine actions to
Reduce each RPN
Analyze the current
controls and determine
Detection Rating
Identify the Cause
and Occurrence Rating
Determine the
Effects and Severity Rating
Identify the
failure modes
Map the process
Assemble the Team
Management review
and approval
Customer Feedback
Field Failure Data
Yield / Rework Data
Process Experience
Inspection Results
Gauge R&R
Inputs

The FMEA Process
1. Assemble a cross-functional team of people with diverse knowledge about
the process, product or service and customer needs.
2. Identify the scope of the FMEA.
 for Safety, concept, system, design, process, or service?
3. Identify the items: process steps, components, subsystems, parts,
assemblies
4. For each item, identify the possible failure modes
 What could go wrong?
5. Identify all the consequences or effects of each failure mode
6. Determine the Severity of each failure mode
 rate it on a scale of 1-10 where 1 is not severe and 10 is extremely severe
7. Determine all the potential root causes

The FMEA Process
8. For each cause, determine the Occurrence rating
 occurrence estimates the probability of the failure occurring
 rate it on a scale of 1-10 where 1 is infrequent and 10 is commonplace
9. Identify current process controls for each cause
10. Determine the Detection rating based on the effectiveness of the current
process controls
 rate it on a scale of 1-10 where 1 is highly detectable and 10 is not detectable
11. Calculate the risk priority number, or RPN
 RPN = [Severity] × [Occurrence] × [Detection]
 Rank Failure modes according to the estimated risk factor (RPN)
12. Identify actions to lower the severity and occurrence, and / or add
controls to improve detection.
13. Actions are assigned to owners, completed, validated and closed
14. Risk factors (Severity, Occurrence, and Detection) are then re-evaluated
after remedial action has been completed

Traditional Methods
Paper forms
Excel Spreadsheets
Problems
 Difficult to work collaboratively
 Difficult to audit
 No user based restrictions to protect data integrity
 Difficult to manage
 No concise reports for actions due
 Poor visibility to FMEA effectiveness

SBS FMEA Database Advantages
Easy to use
 Collaborative platform
 Simple, menu driven user interface
 Easy to train users
Convenient, intuitive forms
 Can restrict users to control data integrity
Rich set of reports
 Easy to identify delinquencies, stalled actions
 Reports may be emailed with a single click
 Export data to Excel for further analysis
Built using Microsoft Access
 Common, convenient software platform
 Runtime version of Access is available as a free download

USING THE FMEA MODULE
Using the SBS FMEA Module in the SBS Quality Database

Key Features
List items, process steps, or functions
 Identify Failure Modes for each
 Identify effects and severity
 Identify causes and frequency
 Identify current controls and detection level
 Develop multiple actions associated with this failure mode
 Assign owners and due dates
 Establish verification and validation criteria
Electronic signature for management approval
Rich set of reports
 Track open actions and delinquent due dates

FMEA form - Details
Data Organized into 3 tabs
FMEA details determine
the type and scope
Define the Team
Approvals and edits

FMEA form - Details
Data Organized into 3 tabs
FMEA details determine
the type and scope
Define the Team
Electronic signatures to
document approval and closure

FMEA Form – Failure Modes and Actions
For each Failure mode, you may create any
number of actions to reduce the RPN
Actions include acceptance
criteria and validation

FMEA Form – Comments and Attachments
Supporting documentation
may be linked to the FMEA

FMEA Form - Reports

FMEA Form – Reports (FMEA Actions)

Reports and Analysis
Report filters
Reports and
analysis

FMEA SET-UP
FMEA Set-up and Configuration

FMEA Set-up
Edit FMEA Types and RPN Ratings
 FMEA Types
 Classification
 Severity
 Occurrence
 Detection
Customize your RPN rating to meet your requirements

Set-up Parameters Set-up parameters
are organized into
multiple tabs

Set-up Parameters – FMEA Types
Used in FMEA
Type list

Set-up Parameters – Classification

Set-up Parameters – Severity Rating
Customizable
 For example: change scale from 1-10 to 1-3
Short description shows in Severity List

Set-up Parameters – Occurrence Rating

Set-up Parameters – Detection Rating

USING THE SWOT MODULE
Using the SWOT Module in the SBS Quality Database

SWOT Form
Form organized
into 3 tabs

SWOT Matrix

SWOT Actions
Manage Actions to reduce risk

SWOT Report

Meeting Manager
Document meeting minutes
Track and manage meeting actions
Drive Continual Improvement at the management level
Use for mission critical meetings

Meeting Manager
Track Mission Critical meetings:
 Quality Management System Reviews
 Safety Meetings
MRB meetings
 Design reviews
 Daily operations meetings
Document meeting decisions and actions
Maintain an auditable record of compliance
Demonstrate evidence of risk based thinking
Meeting Manager is organized in 4 tabs
 QMS Details
 Data Review
 Actions and Validation
 Comments and files

Meeting Manager – Meeting Details

Meeting Manager – Data Review

Meeting Manager - Actions and Validation

Meeting Manager – Comments and Attachments

Meeting Manager - Reports

Simple 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

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

SBS Quality Database
Best in class software solution

Summary
The SBS Quality Database is a cost effective tool to
Ensure effective training compliance with Quality standards
 ISO 9001:2015
 AS 9100
 TS 16949
 ISO 13485
 ISO 14001
Manage Corrective and Preventive Actions
Document Risk management
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.
Applies Lean Manufacturing principles to Quality Management Systems
Sells affordable and efficient software solutions to help implement
ISO9001:2015 compliant systems
 Document Control
 Corrective and Preventive Actions
 Audit Management
 Employee Training
 Control of calibrated equipment
 Vendor Management
 SPC
 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
Sunday
Business
Systems

© 2013 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

Corrective Actions and Risk management for ISO 9001:2015

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