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Automated Packaging Understanding ISO 9001 / Documentation Requirements

Iso 9001 understanding rev3

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Page 1: Iso 9001 understanding rev3

Automated Packaging Understanding ISO 9001 / Documentation Requirements

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1. Minimum knowledge (ISO Requirements)1. Minimum knowledge (ISO Requirements)

2. Current quality manual repeats the standard 2. Current quality manual repeats the standard (Not used) (Not used)

3. QPM procedures missing that show compliance3. QPM procedures missing that show compliance to key processes and interaction with ISO to key processes and interaction with ISO

GAP ANALYSIS Of ISO-GAP ANALYSIS Of ISO-9001 9001

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4. Too many work instructions to control4. Too many work instructions to control

5. Internal audits not auditing to a process5. Internal audits not auditing to a process approach system. approach system.

6. Process approach not mentioned 6. Process approach not mentioned

7. SGS7. SGS

GAP ANALYSIS Of ISO-GAP ANALYSIS Of ISO-9001 9001

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Internal Standard Internal Standard OrganizationOrganization

ISO-9001:2008 ISO-9001:2008 Piece Of The Piece Of The

PuzzlePuzzle

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4.1 General Requirements : Shall establish, document, implement and maintain.

Identify the processes needed; Determine the sequence needed;Determine criteria and methods needed; Availability of resources necessary to support an operation;Monitor, measure and analyze the processes;Implement actions necessary to achieve planned results.

4.2 Documentation Requirements:Quality Policy Quality GoalsQuality ManualProcedures: 6 Required Maintain records: 13 different types

4.2.2 Quality Manual: Scope Justification for any Exclusions , Reference to Procedures, Description of the interaction between processes.

4.2.3 Control of Documents:Approval of documents prior to useDocumented procedure Review and update and re-approval Changes and current revision is identified Current revisions available at use Remain legible External documents are identified Distribution controlled Prevent use of obsolete documents Apply suitable identification if retained for any purpose.

4.2.4 Control of Records:Documented Procedure Remain legible Readily identifiable Retrievable Storage Protection Retention time and disposition of records.

Clause 4 – Quality Management System Sets requirements to identify, plan, document, operate and control QMS processes and to continually improve the effectiveness of our QMS system. (5 elements)

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5.1 Management Commitment:Top Management shall: Communicate importance of meeting customers requirementsEstablish a Quality Policy Establish Quality ObjectivesConduct Management ReviewsEnsure availability of Resources

5.2 Customer FocusRequirements DeterminedRequirements are metAim to enhance customer satisfaction

5.3 Quality PolicyAppropriate to the OrganizationCommitment to comply with requirementsFramework for establishing and reviewing Quality ObjectivesCommunicated and understoodReviewed continually

5.4. Quality ObjectivesEstablished Meet requirements for productMeasurable and consistent with the Quality Policy

5.5 Responsibility, Authority and CommunicationResponsibility and Authority is defined and communicatedAppoint a Member of Management for Management Reviews Process are established, implemented and maintainedReport to Top Management Promotion of Customer RequirementsAppropriate communication process established and takes place

5.6 Management ReviewTop Management must attendPlanned IntervalsReview Input Review Output

#1 Commandment Thou shall have Management Commitment

Management Responsibility

Clause 5 – Management Responsibility – Top Management shall provide evidence of its commitment to the development, implementation and continually improving the QMS system. (6 elements)

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6.1 Provision of ResourcesDetermine and provide resources needed to implement and maintain Quality System continually improve its effectiveness enhance customer satisfaction meeting customer requirements

6.2 Human ResourcesCompetent PersonnelAppropriate education, training, skills and experience

6.3 InfrastructureDetermine, provide and maintain to achieve product requirementsInfrastructure includes: building workspace associated utilities process equipment (both hardware and software) supporting services (transport and communication)

6.4 Work EnvironmentDetermine and Manage to achieve product requirements

Resource Management

Clause 6 – Resource Management Sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements. (4 elements)

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7.1 Planning of Product RealizationPlan and develop processConsistent with requirementsMaintain quality objectiveEstablish documentsProvide resources specific to processVerification, validation, monitoring, inspection and test activities for product acceptanceRecords as evidence that processes and product meet requirements

7.2 Customer-related ProcessesDetermination of requirements related to the productReview of requirement related to the product

7.3 Design and DevelopmentNo Applicable to CRT

7.4 PurchasingPurchasing ProcessPurchasing InformationVerification of purchased product

7.5 Production and Service ProvisionControl of production and service provisionValidation of processes for production and service provisionIdentification and traceabilityCustomer propertyPreservation of Product

7.6 Control of Monitoring and Measuring DevicesDetermine what monitoring and measurement devices neededDevices needed to provide evidence of conformityEstablish processes were monitoring and measurement can be carried outProcesses carried out that is consistent with requirementsMeasuring equipment calibrated, prior to use, against standards and verification recorded

Clause 7 – Product RealizationSets requirements to plan, operate and control the specific QMS processes that determine design, produce and deliver APS’s product and services. (6 elements)

Management Analysis and Improvement

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8.1 GeneralDemonstrate conformity of productEnsure conformity to the quality management systemContinually improve the effectiveness

8.2 Monitoring and Measurement8.2.1 Customer SatisfactionMonitor information relating to customer perception

8.2.2 Internal AuditAudits at planned intervalsAudits conducted on planned arrangementsAudits conducted on International StandardAudit conducted on the Quality Management SystemDocumented Procedure Define scope, frequency and methods Determine status and importance Results of previous audits shall be taken in consideration Auditor can not audit their own work Corrective Action must be taken without delay Follow-up activities required.

8.2.3 Monitoring and Measurement of ProcessesApply suitable methods for monitoring and measuring the processDemonstrate ability to achieve planned results of the process

8.2.4 Monitoring and Measurement of ProductCharacteristics of the product requirements are metCharacteristics are measured at different stages of the processRecords of conformity is maintainedRecords must have authorized personnel listedProduct release and service delivery can not happen until planned arrangements are satisfactory.

Management Analysis and Improvement

Clause 8 – Measurement, Analysis and ImprovementSets requirements to plan, measure, analysis and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness. (10 elements)

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8.3 Control of Nonconforming ProductEnsure nonconforming product is identified and controlledDocumented Procedure Take action to eliminate nonconforming material Release nonconforming product by relevant authority only Prevent its original intended use by taking actionMaintain recordsRe-verification to demonstrate conformityProduct is detected after delivery, action must be taken

8.4 Analysis of DataDetermine, collect and analyze data for suitability and effectivenessProvide information relating to Customer Satisfaction Conformity to Product Requirements Characteristics and trends of process and product Opportunities for preventive action Suppliers

8.5 Improvement8.5.1 Continual ImprovementContinually improve through use of Quality Policy Quality Objectives Audit Results Analysis of Data Corrective and Preventive Action Management Review

8.5.2Corrective ActionTake action to eliminate the cause of nonconformitiesAppropriate to the effects of the nonconformities encounteredDocumented Procedure review nonconformities determining the causes evaluating the need for action ensure nonconformities do not recur determining and implementing action needed records of results reviewing corrective actions

8.5.3 Preventive ActionDetermine action to eliminate the causes of potential nonconformitiesBe appropriate to the effects of the potential problemsDocumented Procedure determine potential nonconformities determine and implement action maintain records review preventive action

Management Analysis and Improvement

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Internal Standard Internal Standard OrganizationOrganization

ISO 9001:2008 Quality Management Systems

Management Responsibility

Quality Management

System

Resource Management

Management Analysis and Improvement

Management Analysis and Improvement

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ISO DOCUMENTATIONISO DOCUMENTATION

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To some companies, the point of ISO 9001 registration is to get a certificate.

While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized by an organization.

The QMS Quality Management System must be planned and implemented by Top Management. In most cases the understanding of the requirements is that a lot of procedures and documents are needed. So the myth of ISO 9001 being a documentation nightmare is still a common misconception at many levels of management.

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To some organization, the point of ISO 9001 registration is to get a certificate to convince customers that procedures are in place and they comply to the standard. A certificate can be a very expensive piece of paper if that is the only benefit realized by an organization.

The (QMS) Quality Management System must be planned and implemented by Top Management.

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One of the major issues of the previous revision of the standard was that it required extensive documentation. The new revised standard has significantly reduced mandatory documented procedures. It has given greater flexibility to determine the documented procedures and instructions based on the nature of activities and processes.

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5.6.1 Management reviews 6.2.2 (e) Education, training, skills and experience 7.1 (d) Company-defined records needed to provide evidence that the realization processes and resulting product fulfill requirements 7.2.2 Results of the review of requirements related to the product and actions arising from the review 7.3.2 Design and development inputs relating to product requirements 7.3.4 Results of design and development reviews and any necessary actions 7.3.5 Results of design and development verification and any necessary actions 7.3.6 Results of design and development validation and any necessary actions 7.3.7 Results of the review of design and development changes and any necessary actions 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations 7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement 7.5.3 The unique identification of the product, where traceability is a requirement 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use 7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements 7.6 Results of calibration and verification of measuring equipment 8.2.2 Internal audit results and follow-up actions 8.2.4 Indication of the person(s) authorizing release of product. 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained 8.5.2 Results of corrective action 8.5.3 Results of preventive action

6 Required Procedures:

21 Required Records:

4.2 DOCUMENTATION REQUIREMENTS4.2 DOCUMENTATION REQUIREMENTS

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So does our Quality Management System have to be complicated and cumbersome?

We Need To Avoid Drowning in Detail…..

Complying with ISO 9001:2008 does not have to be a “document nightmare.” Understanding the requirements of the standard and developing ways to meet them is what we need, “A review of the standard”.

ISO 9001 can only be a documentation nightmare if we choose to make it so.

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The old adage frequently applied to ISO 9001 is “Say what you do and do what you say.”  Some of us seem to take this to mean “Write down everything you do,” but that is not required by the standard.  The actual requirement is that processes are well-defined and responsibilities clearly communicated.  This can be accomplished through a lot of methods that require little documentation, such as training.  The key concept is that the goal is to use the ISO 9001 standard to improve our business, and if it becomes a burdensome paper bureaucracy, then that is probably not happening. Using a Leaner (meaning not wasteful) approach to ISO 9001 is one way to ensure saving time in our documentation and cost in revising / reviewing documents.

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There is nothing in the ISO requirements that says a Quality Manual / QMS Quality Management System procedures needs to be 50 pages or more. However, most Quality Manual seem to follow the pattern of addressing each and every ISO 9001 “shall” statement by essentially repeating the standard’s requirements as we have in our APS Quality Manual. This is an incredible waste of time and cost! (see examples)

ISO 9001 Quality Management ISO 9001 Quality Management SystemSystem

Waste is hidden in all processes Identifying and eliminating wasteWhen waste is identified, it becomes clear that it adds no value to the customer and increases our operating cost.

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ISO 9001 Quality Management ISO 9001 Quality Management SystemSystem

Clause 4.2.2 of ISO 9001:2008 states the following:The organization shall establish and maintain a quality manual that includes;a)the scope of the quality management system, including details of and justification for any exclusions.b)the documented procedures established for the (QMS) Quality Management System, or reference to them.c)and a description of the interaction between the processes of the (QMS) Quality Management System.

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APS Current Quality ManualAPS Current Quality Manual

Repeats Standards

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APS Current Quality ManualAPS Current Quality Manual

Repeats Standards

Over 1500 Work InstructionsOver 1500 Work Instructions

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Purposing a revised Quality Manual Purposing a revised Quality Manual

Core Quality Manual for all of Plastic Core Quality Manual for all of Plastic Operations with basic statements showing Operations with basic statements showing Top Managements commitment to comply Top Managements commitment to comply

with ISO-9001:2008with ISO-9001:2008

See attached Quality Manual examplesSee attached Quality Manual examples

If approved my management to move forward. If approved my management to move forward. This quality manual will replace the currentThis quality manual will replace the current

APS manual in lotus notesAPS manual in lotus notes

Leaner ISO 9001 Leaner ISO 9001 QMS – Quality Management SystemQMS – Quality Management System

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Purposed QMSPurposed QMS Quality Management System ProceduresQuality Management System Procedures

Interact With Other Clauses And Interact With Other Clauses And Elements Of The StandardElements Of The Standard

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Interact With Other Clauses And Interact With Other Clauses And Elements Of The StandardElements Of The Standard

Purposed Quality Management System Purposed Quality Management System Revised FormatRevised Format

Purposed 24 QMS Purposed 24 QMS ProceduresProcedures

The Quality Manual must be reviewed and implemented by The Quality Manual must be reviewed and implemented by Top Management. Top Management.

The QMS Quality Management System documentation The QMS Quality Management System documentation must be reviewed and implemented by Process Owned must be reviewed and implemented by Process Owned Management. Management.

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The goal of our QMS Quality Management System procedures is to document key processes. The ISO 9001 Standard does not specify any format for writing procedures, nor does it specify a length. Since no one wants to read long-winded, boring procedures – why write them?  Why not write one, two or three page procedures using brief and easy to understand?  I am proposing using a LEAN approach which makes procedures more useful so they can benefit us instead of being a paper burden.

Lean ISO 9001 Lean ISO 9001 Quality Management SystemsQuality Management Systems

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Quality Manual, Quality Policy

(QMS) Quality Management System

Procedures

Plastics Operations Training Instructions, Work Instructions,

Operator Instructions

Records, Forms, historical data

ISO-9001:2008 Standard

Level 1

Level 2

Level 3

Level 4

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TOP Level Core ManualTOP Level Core Manual

Level 1Level 1 The Quality Manual is the core of the quality system gives a brief description of APS’s quality policy, objectives and is separate and distinct from the (QMS) Quality Management System procedures.

The purpose of this level of documentation is used externally / internally to introduce our (QMS) Quality Management System to our customers and other external organizations or individuals to show that Top Managements is commitment in implementing and complying with ISO-9001:2008 requirements.

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QMS – Quality Systems ProceduresQMS – Quality Systems ProceduresProcess ApproachProcess Approach

Level 2 Level 2 Uses a process approach (QMS) Quality Management System that which define the methods, interaction, assign responsibilities and authorities, tasks and activities in meeting ISO 9001:2008 requirements.

Section 4.1 c) of the ISO 9001:2008 standard requires we are to determine criteria and methods needed to ensure that both the operation and control of processes are effective. It does not require the methods and criteria to be defined in procedures; other methods may be used.

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Work InstructionsWork InstructionsLevel 3Level 3

This level of documentation is very detailed on "how" to accomplish a specific job, task or assignment. For example, a work instruction could be developed for a product with step-by-step instructions including such detail as testing requirements.

Individual work instructions are very specific to the process(s).

Supplemental documentation may be used including User's Manuals, Engineering or Technical Manuals, Technical Support notes, Manufacturing Notes, etc., in order to create detailed work instructions.

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The last level of documentation can include forms, records, checklists, surveys, and other documents used in the production or delivery of a product or service.

Level 4 - Forms and other Level 4 - Forms and other DocumentsDocuments

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ISO-9001:2008 Clause .2 ISO-9001:2008 Clause .2 Process ApproachProcess Approach

What Is Process Approach?What Is Process Approach?

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The ISO-9001:2008 Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS System.

Promote Clause .2 Process ApproachPromote Clause .2 Process Approach

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"Core" processes (also known as Customer-Oriented-Processes) are product realization processes that determine customer requirements. These processes have a direct impact on the customer.

Examples of core processes include: •Design & Development •Production (manufacturing, outsourcing, testing, etc.) •Invoicing

(COP’s)(COP’s)

Clause .2 Process ApproachClause .2 Process Approach

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“These processes ('SOPs') (also known as Support-Oriented-Processes) provide the necessary resources to COP’s to facilitate product realization.

Some support functions are: Purchasing - Supplier management processes, Requisitions, Request for QuoteOthers – Quality, HR, IT, Engineering, Training

(SOP’s)(SOP’s)

Clause .2 Process ApproachClause .2 Process Approach

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“These processes ('MOPs') (also known as Management-Oriented Processes) provide the commitment, leadership, resources, review and decision-making by Top Management.

Examples of management processes include: •Quality policy and objectives •Planning (Strategic, Operational) •Resource management •Customer focus •Management reviews•Corrective Action•Control of documents and records

(MOP’s)(MOP’s)

Clause .2 Process ApproachClause .2 Process Approach

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Clause .2 Process ApproachClause .2 Process ApproachMOP’sMOP’s MOP’s Management Oriented Processes

CORE PROCESSES = COP’s Customer Oriented Process

Support Oriented Processes

Cu

sto

mer

Ne

eds

/ R

equ

irem

en

tsC

ust

om

er N

eed

s /

Req

uir

eme

nts

Cu

sto

mer

Sat

isfa

cti

on

Cu

sto

mer

Sat

isfa

cti

on

Control of Documents

Control of Records

Customer Satisfaction

Continual Improvement, Corrective & Preventive Action

Internal Auditing

Quality Planning

Quality Objectives

Management Review

COP’sCOP’sSales Graphics

Art, Imaging, Plates

Customer Service

Extruding

Printing Converting

Shipped Internally

Shipped Internally

Shipping

SOP’sSOP’sCalibrationTrainingMaintenancePurchasing

Analysis of Data

Policy

Input Output

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Promoting The Use Of Process Promoting The Use Of Process Approach During Internal AuditingApproach During Internal Auditing

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Process Based Auditing Current Internal Audits: are conducted as an independent examination or review of the single process (Department).

Proposed Processed Based Audits Process audit reviews system of linked processes such as Inputs: that come into the process, Outputs: of what you expect from the process .

A Change In Internal AuditingA Change In Internal Auditing

Using Turtle Using Turtle DiagramsDiagrams

Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process These process interactions create a single process-based QMS systeminteractions create a single process-based QMS system.

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Clause .2 Process ApproachClause .2 Process ApproachTurtle DiagramTurtle Diagram

Requirem

ents

Requirem

ents

Process

Name OF Process Name Of Owner

With Who / Responsible Parties

Enter details of the personnel involved, training, skills and competence

criteria etc.

Resource's / With What

Detail what are the necessarymachines, raw materials, equipment,

software infrastructure etc.

Key Criteria / Measure

Enter how is the analysis of the process effectiveness accomplished? details objectives, measurables of

the process effectiveness, targets, and results etc.

Operational Control / How

Enter details objectives, measurables of the process effectiveness, targets, and

results etc.

Inputs What Come in And What Does The

Customer Want?

Enter details of the actual inputs required

by the process.

Enter internal requirements, external

requirements, tools, materials, schedules etc.

Output What do you expect And What

Does The Customer Get?

Enter details of theactual output of the process, records, customer quality

Products, customer satisfaction, etc.

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Clause .2 Process ApproachClause .2 Process Approach

Turtle DiagramTurtle Diagram

Inputs R

equirements

Output

Requirem

entsProcess Audited

Management Responsibility

With Who / Responsible Parties

Top Management, Department Managers

Resources / With What

ISO-9001, Cross-Functional Audit Team, CAR System, Business Plan,

Performance Measurables

Operational Control / QMS Procedures

QMS Procedures, Core Clauses: Customer Specifics, 4.1, 4.2, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 7.2.3,

7.3.4, 8.2.1, 8.4, 8.5

Key Criteria / Measure

Internal Audits, Performance Measurables, Management Review,

Customer Satisfaction, CAR System, measurables of the process

effectiveness, targets, and results etc.

Inputs What Come in And What Does The

Customer Want?

ISO Requirements, Resources,

Infrastructure, Plant Layout, Required

Records, Customer Specifics, Training, Quality Objectives,

Communication

Output What do you expect

Policy, Objectives, Customer Satisfaction,

QMS Compliance, Controlled Records,

Continual Improvements

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Master Audit Checklist Score 0730MANUFACTURING INTERNAL AUDIT REPORT BEDFORD FACILITY AUDITED: ❑ STREETSBORO DATE OF

AUDIT:

SHIFT(s) AUDITED: ❑ 1st Shift

GARFIEL ❑ SANTA FE ❑ SPO ❑ KEYSER

AUDITEE(S)

AUDITEE(S)

AUDITOR:

2nd Shift ❑ 3rd Shift

Evaluation Guideline Audit Results Rating Guideline Score (%) Classification

Total Possible Points

Total Points This Audit

Audit Classification

Overall Audit Score

0 3 Is In Place And Being Followed 90 -100 Complies

2 In Place But Not Being Followed For All Processes 75 -89 Observation 0

1

MP! Is In Place But Not Being Followed 61 - 74 Minor Issue Major

Not In Place And No Evidence 60 Or Less

-100.000%

N/A Not Applicable Question Does Not Apply

Clause Score Results Clause Score Results

4.1 General Requirements 0.0% Major 7.1 Planning of Product Realization 0.0% Major

4.2 Documentation Requirements 0.0% Major 7.2 Customer-Related Processes 0.0% Major

5.1 Management Commitment 0.0% Major 7.3 Design and Development 0.0% Major

5.2 Customer Focus 0.0% Major 7.4 Purchasing 0.0% Major

5.3 Quality Policy 0.0% Major 7.5 Production and Service Provision 0.0% Major

5.4 Planning 0.0% Major 7.6 Control of Monitoring and Measuring Equipment

0.0% Major

5.5 Responsibility, Authority and Communication

0.0% Major 8.1 General 0.0% Major

5.6 Management Review 0.0% Major 8.2 Monitoring and Measuring 0.0% Major

6.1 Provision of Resources 0.0% Major 8.3 8.4 Analysis of Data 0.0% Major

6.2 Human Resources 0.0% Major 8.4 Analysis of Data 0.0% Major

6.3 Infrastructure 0.0% Major 8.5 Improvement 0.0% Major

6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major

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SGS RegistrarSGS Registrar

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FICCI CE

With the dedication of all employees, we as a company constantly strive to meet our customer needs through

quality and continuous improvements.

With the dedication of all employees, we as a company constantly strive to protect the environment and

prevent pollution through continual improvement and compliance to environmental regulations and

procedures.

Quality PolicyQuality Policy

Environmental PolicyEnvironmental Policy

Examples For Revision Of Our PoliciesExamples For Revision Of Our Policies

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That’s a wrap!That’s a wrap!Thank you!Thank you!