quality program overview

John Cover, CQA (ASQ), CTBSDirector, Quality Assurance

Science Care

American Association of Tissue Banks Quality Assurance Workshop X

November 12th, 2008

Quality Program OverviewElements, Effectiveness and Examples

Quality Program OverviewAATB Quality Assurance Workshop XJohn Cover

“Long-term commitment to learning and new philosophy is required of any management that

seeks to improve quality and productivity.

The timid and the faint-hearted, and people that expect quick results are doomed to

disappointment.” 1

- W. Edwards Deming


Sometimes we all feel like this:


Agenda

• Quality Fundamentals

• Quality Program Objectives

• Adopt A New Philosophy

• Quality Program Elements

• Quality Program Examples


Quality Fundamentals

Definition of Quality:

• Quality indicates the cumulative characteristics of a good or service that speaks directly to the voice of the customer.

• Quality should also reflect the cumulative characteristics of the environment that supports the production of goods and services that directly speaks to the voice of the customer.

• Quality should further reflect the empowerment of all stakeholders to improve the environment that supports the production of those goods and services.


Quality Fundamentals

Product or Service:Quality indicates the cumulative characteristics of a good or service that

speaks directly to the voice of the customer.

Quality Program: Quality should also reflect the cumulative characteristics of the

environment that supports the production of goods and services that directly speaks to the voice of the customer.

Culture and Oversight:Quality should further reflect the empowerment of all stakeholders to

improve the environment that supports the production of those goods and services.


Quality Program Fundamentals

• Your Quality Program is far bigger in scale than your Quality Assurance department. Don’t confuse the two.

• You must have Top Management Commitment. This must be formally documented and evidence of the commitment must be maintained.

• Identify your internal and external customers

• Determine how you can meet the needs of your internal customers.

• Determine the VOC of each customer: The Voice of the Customer (VOC) describes the spoken and unspoken true needs of the recipient of one’s goods or services.


Quality Program Objectives

• Deployment of the objectives. Quality policy and quality objectives should be broken down at relevant functions and levels of the organization. It is therefore important to identify which functions and levels are responsible.3

• Deployment of relevant personnel. It is necessary to identify how relevant personnel achieve the relevant objectives.3

• Confirmation of the achievement. It is necessary to clearly determine whether the quality objectives are achieved or not, in whatever way, either in quantitative or qualitative manner. 3

• Consistency with the quality policy. The quality objectives should be consistent with the quality policy or management, and it is necessary to pay attention to that consistency.


Quality Program Fundamentals

GIGO

Quality

Program

Garbage In

Garbage Out


Don’t be afraid to shake things up a little to challenge existing paradigms:


Adopt A New Philosophy

From the Juran Trilogy 5:

• Quality Planning:

• Determine who the customers are.

• Determine the needs of the customers.

• Develop product features that respond to customer’s needs.

• Develop processes that are able to produce those product features.


Adopt A New Philosophy

How to begin the work of Quality Culture Change:

From Deming's 14 Points 4:

• Adopt a new philosophy.

• Create constancy of purpose.

• Break down barriers between departments.

• Remove barriers that rob workers…of their right to pride of workmanship.

• Institute a vigorous program of education and self improvement.

• Put everyone in the company to work to accomplish the transformation.


“Our plans miscarry because they have no aim. When a man does not know what harbor he is

heading for, no wind is the right wind.”

- Seneca (4BC-AD65)


Quality Program ElementsMission & Goals

Mission&

Goals

“Quality will be a focus in the organization’s strategic planning and

in its mission statement.”2

“Develop and monitor the quality mission and policy and ensure

alignment with he organization’s broader mission.”2

The Quality Mission Statement should never deviate from the

organization’s mission statement, but it should enhance it from a quality perspective and with a

customer focus.


Quality Program ElementsQuality Policy

Quality

Policy

Mission&

Goals

“A quality policy is a formalized document created to

communicate the overall intentions and directions of the organization s they related to

quality.”2

“The quality policy should summarize the organization’s

view on the definition of quality, the importance of quality, quality

competitiveness, customer relations, internal customers,

workforce involvement, quality improvement, planning...”2


Quality Program Elements

QualityPlan

Quality Plan

“The Quality Plan is a document, or documents, that specify quality standards, practices, resources,

specifications and the sequence of activities relevant to a particular

product, service, project or contract.”2

Mission&

Goals

Quality

Policy

Components:

Objectives to be obtained

Allocation of responsibilities

Specific documents, standards, practices, etc.

Testing, Inspection, audit programs, examination

Change Management / Achievement Measures 2


Quality Program Elements

QualityPlan

Mission&

Goals

Quality Program Components

Quality Program

Components

Quality

Policy

Complaint Mgmt. Quality Control

Dev. Mgmt. (CAPA)

Equipment

Procedures / SOPM

Enviro. Monitoring

Audit Program Reagents / Supplies

Track & Trend Storage

Validation Facility Controls

Change Mgmt. Records / Review

Personnel In-Process Controls

Training & Education

Competency


Quality Program Examples

QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

(Company Mission Statement).

In order to maintain the highest quality standards for those to which we serve, we commit ourselves

to the following:

Quality Standards

To establish industry leading quality standards to control, monitor and continuously improve the

quality levels of our services.

Customer Satisfaction

To focus on critical key measures which have a direct impact on internal and external customer satisfaction and continuous improvement toward

understanding the voice of the customer.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Continued…..

Ethical Work Practices

To always display and integrate honesty and integrity in all of our processes to further the trust of our donors, their families and ensure

the support of the scientific community.

Employee Empowerment

To involve all employees in all quality aspects of their positions through training, continuous

education and empowerment pathways.

Quality is the responsibility of every

employee.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Policy Component Examples

•Management at all levels must demonstrate control over critical systems by the deployment of appropriate resources.

•Staff must possess the proper education background, experience and training commensurate with the assigned job functions.

•All Company facilities must be designed, supplied and maintained in a manner that provides staff with the proper environment to properly perform the functions of their position.

•Suppliers are to be qualified to provide the Company with services or products that are to be used in accredited operations.

•All documents considered critical to operations are controlled and made available to staff, reviewed, approved and retained. A record management system must be in place to ensure that all records and documents generated are considered confidential and stored in a controlled access location that protects the integrity of the documents.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Policy Component Examples

•Each Company department must control all critical areas of production specific to their department. All areas of production must have in-process controls to ensure the finished product(s) meet required specifications that include: the suitability of donors, verification of proper informed consent, transport and storage, the identity of donors or donor tissue and the final disposition of tissue.

•All procedures used in the performance of critical processes must be standardized, reviewed, approved and all changes to them must be controlled.

•An active and independent Quality Assurance Program must be in place, controlled and must demonstrate independent oversight over Quality Program.

•All training activities be documented concordantly with the performance of each training activity. Staff competency over critical procedures/processes must be determined prior to the staff performing any steps within those procedures/processes.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Independence

The Quality Assurance Department is an independent quality advocate and regulatory adherence monitor for the Company and its affiliated operational entities. All

Quality Assurance functions are independent of operational functions. Oversight over Operational

functions resides with the Executive Management, while the oversight over Quality Assurance functions resides

with the Program Director.

Quality Assurance has a direct reporting relationship to the Program Director. Quality Assurance has an

information relationship to Executive management, the responsible head for each satellite facility, management

at all levels, and all Company staff.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Authority

The Quality Assurance Department authority is given by the Program Director. In the Program Director’s absence, the authority is given by the Executive

Management. This authority extends to all Quality Assurance activities. Activities include: audit authority,

quality improvement documentation approval authority, RCA and CA/PA approval authority, and

production control authority.

At any time, a member of Quality Assurance has the authority to temporally suspend any/all operational function(s), at any time, if necessary to minimize

potential safety risks and/or ensure compliance with subscribed accreditation standards.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

In order to further the Company’s Mission, a Quality Plan has been implemented that will focus on the implementation and maintenance of the following Quality Program key functional

elements:

Quality Improvement Program:

The Company will adhere to a strict program for measuring and improving process performance through identification, root cause evaluation, and problems will be documented,

tracked and/or trended to ensure continuous quality improvement.

Quality Improvement Process:

The Quality Improvement Process will provide a mechanism to detect, correct and document problems or to improve a

process. By accurately and systematically documenting expected or unexpected events, The company will be able to monitor all regulated processes to reveal weak points, focus on continuous improvement, and ultimately create robust systems, processes and procedures required to fulfill our

mission.

.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Root Cause Analysis Process:

The Root Cause Analysis Process will ensure that problems detected are comprehensively analyzed to determine the

deep underlying cause(s) of a process or system problem and the associated contributing factors.

Corrective Action Process:

An effective Corrective Action Process will enable the Company to precisely and systematically develop and

implement solutions that target each identified root cause and contributing factor to a process or system problem. This will ensure that identified problems are effectively corrected to

prevent reoccurrence.

Tracking and Trending:

Tracking and Trending of problems detected by the Quality Improvement Process allows for the effective monitoring of

Company’s critical control points in its processes and systems. This will ensure that all processes and systems remain in a

steady state of control.

.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Audit Program:

All quality systems will be continuously evaluated through a comprehensive audit program designed to detect, correct and ultimately prevent problems from

occurring or re-occurring. Operations and Quality Assurance are partners in this program, each having an

equal stake in the success of the Company and its employees.

Audit Structure:

All the Company’s core operational functions that fall under the scope of the AATB and NYDOH accreditation will adhere to a comprehensive and systematic audit

program. The audit program will monitor all the Company’s eight Quality Systems under Management’s control. The audits will be divided into Functional and Focused audit types and will follow a pre-established schedule. All audits will be performed by quality and

independent Quality Assurance staff.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Audit Schedule:

All predetermined audits will be scheduled in advance and will follow a 12 month (annual) cycle. Annual Operational-Process-

System (OPS) audits and bi-annual record audits for all departments will form the backbone of the audit program. Ancillary systems will be audited annually as per the pre-

determined audit schedule.

Audit Process:

All Quality Assurance Audit functions will be based on the American Society for Quality (ASQ) Quality Auditor Body of

Knowledge and follow all applicable AATB and NYDOH guidelines for quality audits. Pre-established and approved audit work-tools will be used within the agreed scope of the

audit. The auditor and auditee will subscribe to accepted auditing standards for the Audit Preparation phase, Audit

Performance phase, and Audit Closure phase of the company’s audit program.

.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Performance Improvement Program:

The Company will develop and maintain quality systems that will be the foundation for all Company systems, processes, and procedures. The Quality Systems will

ensure that all aspects of the Company’s operations are monitored through the use of quality indicators. The

quality indicators will ensure that all critical control points of our systems, processes, and procedures are monitored to ensure compliance with associated standards as well

as the continuous improvement of the company’s operations.

Quality Systems:

All of the Company’s core operational functions will fall under eight designated Quality Systems. All Company departments will share in each Quality System. AATB

Standards for Tissue Banking will be the primary guide for the components of the quality systems.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Quality Indicators:

In order to determine the Company’s Quality System compliance to AATB standards, the Company will establish and monitor Quality Indicators. The Quality Indicators will

act as corrective action triggers for critical control points in our systems and processes. Information fed into the Quality Indicators will be derived from the Audit Program and the

Quality Improvement Program. The structure of the Quality Indicators will be based on the Quality System as a means

of standardization.

Ancillary Systems:

The Company will implement preventative control measures to ensure that all core operational

systems/processes are documented and changes to them are performed in a controlled manner. These systems will

include Validations, Qualifications, and Change Management Systems. To ensure that the Quality Plan is

effective, employee quality based training initiatives, employee communication pathways and quality

improvement projects will be implemented to ensure continuous quality improvement.



QualityPlan

Mission&

Goals

Quality Program

Components

Quality Policy

Complaint Mgmt. Quality Control

Dev. Mgmt. (CAPA)

Equipment

Procedures / SOPM

Enviro. Monitoring

Audit Program Reagents / Supplies

Track & Trend Storage

Validation Facility Controls

Change Mgmt. Records / Review

Personnel In-Process Controls

Training & Education

Competency

Specific Procedure Sets for:


Effectiveness

• To evaluate the effectiveness of the Quality Program you must first look back to your original objectives. (Where they measureable to begin with?)

• Use various tools to evaluate the effectiveness of the quality system.2

• Balanced Scorecard

• Skip-level meetings

• Management reviews

• Internal Audits

• Feedback from internal and external customers

• Recalls

• Asking questions:

• Are you doing anything with the data you are generating?

• Is you CAPA system healthy?

• Do you have the support of all levels of management?


The aim of a Quality Program is to prevent things like this:


Remember:

Quality Culture change is inevitable if…

You empower others through: training, communication pathways, better tools, and

mentorship.

Focus on improving systems, processes, and performance as a result of heeding the Voice Of the

Customer.

Always keep your internal customers as happy as your external customers.

Never be complacent!


References1. Deming, W. Edwards. Quality, Productivity, and Competitive

Position. Cambridge, MA. MIT, 1982.

2. Westcott, Russell. The Certified Manager of Quality/Organizational Excellence Handbook. Milwaukee, WI. ASQ Quality Press. 2006.

3. Cianfrani, Charles, Tsiakals, Joseph, West, John. The ASQ ISO 9000:2000 Handbook. Milwakee, WI. ASQ Division Press. 2002.

4. Deming, W. Edwards. Out of The Crisis. Cambridge, MA. MIT, 1986.

5. Juran, Joseph. Juran on Leadership For Quality, New York, NY. The Free Press, 1989.

6. Materials included courtesy of Science Care®.


Thank you!

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