Automated Packaging Understanding ISO 9001 / Documentation Requirements

GAP ANALYSIS Of ISO-9001

1. Minimum knowledge (ISO Requirements)
2. Current quality manual repeats the standard (Not used) 3. QPM procedures missing that show compliance to key processes and interaction with ISO

GAP ANALYSIS Of ISO-9001

4. Too many work instructions to control
5. Internal audits not auditing to a process approach system. 6. Process approach not mentioned

7. SGS

Internal Standard Organization

ISO-9001:2008 Piece Of The Puzzle

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 Goals Quality Manual Procedures: 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.

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)

4.2.3 Control of Documents:

Approval of documents prior to use Documented 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.

5.1 Management Commitment:

Top Management shall: Communicate importance of meeting customers requirements Establish a Quality Policy Establish Quality Objectives Conduct Management Reviews Ensure availability of Resources

Management Responsibility

5.2 Customer Focus

Requirements Determined Requirements are met Aim to enhance customer satisfaction

5.3 Quality Policy

Appropriate to the Organization Commitment to comply with requirements Framework for establishing and reviewing Quality Objectives Communicated and understood Reviewed continually

5.4. Quality Objectives

Established Meet requirements for product Measurable and consistent with the Quality Policy

#1 Commandment
Thou shall have Management Commitment

5.5 Responsibility, Authority and Communication

Responsibility and Authority is defined and communicated Appoint a Member of Management for Management Reviews Process are established, implemented and maintained Report to Top Management Promotion of Customer Requirements Appropriate communication process established and takes place

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

5.6 Management Review

Top Management must attend Planned Intervals Review Input Review Output

6.1 Provision of Resources

Determine and provide resources needed to implement and maintain Quality System continually improve its effectiveness enhance customer satisfaction meeting customer requirements

6.2 Human Resources

Competent Personnel Appropriate education, training, skills and experience

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

Resource Management

6.4 Work Environment

Determine and Manage to achieve product requirements

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)

7.1 Planning of Product Realization

Plan and develop process Consistent with requirements Maintain quality objective Establish documents Provide resources specific to process Verification, validation, monitoring, inspection and test activities for product acceptance Records as evidence that processes and product meet requirements

Clause 7 Product Realization Sets requirements to plan, operate and control the specific QMS processes that determine design, produce and deliver APSs product and services. (6 elements)

7.2 Customer-related Processes

Determination of requirements related to the product Review of requirement related to the product

7.3 Design and Development

No Applicable to CRT

7.4 Purchasing
Purchasing Process Purchasing Information Verification of purchased product

7.5 Production and Service Provision

Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of Product

Management Analysis and Improvement

7.6 Control of Monitoring and Measuring Devices

Determine what monitoring and measurement devices needed Devices needed to provide evidence of conformity Establish processes were monitoring and measurement can be carried out Processes carried out that is consistent with requirements Measuring equipment calibrated, prior to use, against standards and verification recorded

8.1 General
Demonstrate conformity of product Ensure conformity to the quality management system Continually improve the effectiveness

8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction

Monitor information relating to customer perception

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

8.2.2 Internal Audit

Audits at planned intervals Audits conducted on planned arrangements Audits conducted on International Standard Audit conducted on the Quality Management System Documented 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 Processes

Apply suitable methods for monitoring and measuring the process Demonstrate ability to achieve planned results of the process

8.2.4 Monitoring and Measurement of Product

Characteristics of the product requirements are met Characteristics are measured at different stages of the process Records of conformity is maintained Records must have authorized personnel listed Product release and service delivery can not happen until planned arrangements are satisfactory.

Management Analysis and Improvement

8.3 Control of Nonconforming Product

Ensure nonconforming product is identified and controlled Documented Procedure Take action to eliminate nonconforming material Release nonconforming product by relevant authority only Prevent its original intended use by taking action Maintain records Re-verification to demonstrate conformity Product is detected after delivery, action must be taken

8.5.3 Preventive Action

Determine action to eliminate the causes of potential nonconformities Be appropriate to the effects of the potential problems Documented Procedure determine potential nonconformities determine and implement action maintain records review preventive action

8.4 Analysis of Data

Determine, collect and analyze data for suitability and effectiveness Provide information relating to Customer Satisfaction Conformity to Product Requirements Characteristics and trends of process and product Opportunities for preventive action Suppliers

8.5 Improvement 8.5.1 Continual Improvement

Continually improve through use of Quality Policy Quality Objectives Audit Results Analysis of Data Corrective and Preventive Action Management Review

8.5.2Corrective Action
Take action to eliminate the cause of nonconformities Appropriate to the effects of the nonconformities encountered Documented 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

Management Analysis and Improvement

Internal Standard Organization ISO 9001:2008 Quality Management Systems Quality Management System Resource Management Management Analysis and Improvement Management Responsibility

Management Analysis and Improvement

ISO DOCUMENTATION

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.

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.

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.

4.2 DOCUMENTATION REQUIREMENTS

21 Required Records:
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:

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

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.

We Need To Avoid Drowning in Detail..

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.

ISO 9001 Quality Management System

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 standards requirements as we have in our APS Quality Manual. This is an incredible waste of time and cost! (see examples)
Waste is hidden in all processes Identifying and eliminating w aste When w aste is identified, it becomes clear that it adds no value to the customer and increases our operating cost.

ISO 9001 Quality Management System

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.

APS Current Quality Manual

Repeats Standards

APS Current Quality Manual

Repeats Standards

Over 1500 Work Instructions

Leaner ISO 9001 QMS Quality Management System

Purposing a revised Quality Manual Core Quality Manual for all of Plastic Operations with basic statements showing Top Managements commitment to comply with ISO-9001:2008 See attached Quality Manual examples If approved my management to move forward. This quality manual will replace the current APS manual in lotus notes

Purposed QMS Quality Management System Procedures

Interact With Other Clauses And Elements Of The Standard

Purposed Quality Management System Revised Format Purposed 24 QMS Procedures

Interact With Other Clauses And Elements Of The Standard

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

Lean ISO 9001 Quality Management Systems

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.

ISO-9001:2008 Standard
Quality Manual, Quality Policy

Level 1

Level 2

(QMS) Quality Management System Procedures

Level 3 Level 4
Plastics Operations Training Instructions, Work Instructions, Operator Instructions

Records, Forms, historical data

TOP Level Core Manual Level 1 The Quality Manual is the core of the quality system gives a brief description of APSs 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.

QMS Quality Systems Procedures Process Approach 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.

Work Instructions Level 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.

Level 4 - Forms and other Documents

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.

ISO-9001:2008 Clause .2 Process Approach

What Is Process Approach?

Promote Clause .2 Process Approach

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

Clause .2 Process Approach

(COPs)
"Core" processes (also known as Customer-OrientedProcesses) 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

Clause .2 Process Approach

(SOPs)
These processes ('SOPs') (also known as SupportOriented-Processes) provide the necessary resources to COPs to facilitate product realization. Some support functions are: Purchasing - Supplier management processes, Requisitions, Request for Quote Others Quality, HR, IT, Engineering, Training

Clause .2 Process Approach

(MOPs)
These processes ('MOPs') (also known as ManagementOriented 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

Clause .2 Process Approach

MOPs
MOPs Management Oriented Processes
Internal Auditing Customer Satisfaction Continual Improvement, Corrective & Preventive Action

Policy

Analysis of Data

Management Review

Quality Objectives

Quality Planning

Customer Needs / Requirements

CORE PROCESSES = COPs Customer Oriented Process

Customer Service Graphics Art, Imaging, Plates Extruding Shipped Internally Shipping

Sales

Printing

Converting

Input
Shipped Internally

Output

SOPs
Purchasing Maintenance

Support Oriented Processes

Training Calibration Control of Documents Control of Records

Customer Satisfaction

COPs

Promoting The Use Of Process Approach During Internal Auditing

A Change In Internal Auditing

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 . 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 interactions create a single process-based QMS system.

Using Turtle Diagrams

Clause .2 Process Approach Turtle Diagram

Resource's / With What Detail what are the necessary machines, raw materials, equipment, software infrastructure etc. With Who / Responsible Parties Enter details of the personnel involved, training, skills and competence criteria 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.

Process
Name OF Process Name Of Owner

Output What do you expect And What Does The Customer Get?

Requirements

Operational Control / How Enter details objectives, measurables of the process effectiveness, targets, and results etc.

Requirements

Enter details of the actual output of the process, records, customer quality Products, customer satisfaction, 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.

Resources / With What

Clause .2 Process Approach Turtle Diagram

With Who / Responsible Parties Top Management, Department Managers

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

Inputs What Come in And What Does The Customer Want?

Output Requirements

Inputs Requirements

Process Audited
Management Responsibility

Output What do you expect

ISO Requirements, Resources, Infrastructure, Plant Layout, Required Records, Customer Specifics, Training, Quality Objectives, Communication

Policy, Objectives, Customer Satisfaction, QMS Compliance, Controlled Records, Continual Improvements

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.

Master Audit Checklist Score

0730 MANUFACTUR ING

INTERNAL AUDIT REPORT

G AR F I E L SANTA FE S P O

FACILITY AUDITED: STREETSBORO DATE OF AUDIT: SHIFT(s) AUDITED:

BEDFORD AUDITOR:
2nd Shift 3 r d S h i f t

KEYSER AUDITEE(S) AUDITEE(S)

1 st Sh i f t

Evaluation Guideline
Rating Guideline Score (%) 3 Is In Place And Being Followed 90 -100 Classification Complies

Audit Results
Total Possible Points
Total Points This Audit Audit Classification Overall Audit Score 0 0 Major -100.000%

In Place But Not Being Followed For All Processes

Is In Place But Not Being Followed Not In Place And No Evidence Not Applicable Clause Score 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%

75 89
-

Observation
Minor Issue

MP!
N/A

61 - 74 60 Or Less

Question Does Not Apply Results Major7.1 Major7.2 Major7.3 Major7.4 Major7.5 Major7.6 Major8.1 Major8.2 Major8.3 Major8.4 Major8.5 Major Planning of Product Realization Customer-Related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Equipment General Monitoring and Measuring 8.4 Analysis of Data Analysis of Data Improvement AIB Pest Control Clause Score 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% Results Major Major Major Major Major Major Major Major Major Major Major Major

4.1 4.2 5.1 5.2 5.3 5.4 5.5 5.6 6.1 6.2 6.3 6.4

General Requirements Documentation Requirements Management Commitment Customer Focus Quality Policy Planning

Responsibility, Authority and Communication

Management Review Provision of Resources Human Resources Infrastructure Work Environment

SGS Registrar

CE FICCI

Examples For Revision Of Our Policies

Quality Policy
With the dedication of all employees, we as a company constantly strive to meet our customer needs through quality and continuous improvements.

Environmental Policy
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.

Thats a wrap! Thank you!