QMS AWARENESS

QUALITY MANAGEMENT AWARENESS

WCH Professional Services, LLC

(570)350-9256

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WCH Professional Services was founded in 2003 in order to help organizations that are looking to grow their business and offerings. Through long-standing relationships with other experts in the industry, WCH Professional Services is a full service consulting firm that can help your company move confidently and efficiently in profitable directions. WCH Professional Services, LLC provides training and consulting services in regulatory compliance, certification and registration. Our expertise ranges from upper management level program overviews and strategic planning through mid-management level overview and program structure formation to the procedure development and documentation required for implementation. Our experience covers industries that include forgings, machined parts and assembled systems, electronics and electrical systems, medical devices, pharmaceutical chemicals and packaging, aerospace designs / components / assemblies, automotive components, food processing, wire rope, and service-oriented industries. WCH provides expert consulting and / or subcontracting services that enable your company to complete projects without hiring a full-time employee, saving your company benefit money, unemployment compensation and SSI contributions. WCH helps your company to find and apply for grants that may pay for 50 to 75% of our services. We listen to your needs, apply grant money to your specific projects and work with you instead of giving you a list of items for your organization to do.

(570)[email protected] WCH Professional Services, LLCWe Can Help!

(570)[email protected] WCH Professional Services, LLC

STANDARDS TRAINING / CONSULTING AND AUDITINGAS9100, ISO 9001, ISO 13485, ISO 14001, ISO 17025, OSHAS 18001, TS 16949, cGMP, FDA Compliance SAFETY & ENVIRONMENTAL SERVICESISO 14001 & OSHAS CertificationEnvironmental and /or Safety Manuals / ProceduresEmergency Response PlansSpill Prevention Response Plans (SPRP)Preparedness, Prevention and Contingency Plans (PPCP)MSDS to SDS Conversion (GHS and REACH Compliant) BUSINESS MANAGEMENT SERVICESBusiness Management Software - ERPReport Writing - Gupta, Crystal ReportsBusiness Health Analysis - Financial, OperationalProduct Cost Understanding / ImprovementQuality Management Services WRITING / PUBLISHINGGhost Writing, Legal Writing, Procedure Writing, Technical Writing, Trade Magazine Advertisements GENERAL MANUFACTURING / DESIGN SERVICESElectro-Mechanical Design SupportCE, CSA or UL Product Certification SubmittalsEquipment / Product Manuals

Our Services

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QUALITY SYSTEM ATTRIBUTES

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Words of wisdom from Victor Schur (Sears):

“A Quality System must be S.E.D.A. --- Suitable - Documented- Effective - Auditable

Words of wisdom from Ian Durand (US Technical Advisory Group to ISO TC 176):

“The basis of a quality system is to say what you do, do what you say, record what you did, check the results, and act on the difference.”


WHY STANDARDIZE QUALITY MANAGEMENT SYSTEMS?


Provides a common basis for doing business and managing quality, globally,

Allows diverse companies to exchange products and services with greater confidence, and

Reduces the need to satisfy multiple (often contradictory) standards.


WHAT DOES THE STANDARD ACCOMPLISH?


Gives the organization confidence that customer requirements are being met

Gives the customer confidence that products and services are consistent

Provides or sustains market entry

Helps an organization achieve, sustain, and improve product/service quality by managing the processes that create them


THE STANDARD IS NOT ...


A Panacea. It alone won’t solve all problems related to quality

Prescriptive. It tells you What, not How

All You Need to Do. It only specifies minimum requirements for an effective quality system … i.e. one that is capable of meeting all customer and other applicable requirements

The Ultimate Goal. Our competitive edge depends on our ability to constantly improve and strive for excellence in meeting the needs and expectations of all interested parties (customers, shareholders, employees, society)


COMPONENTS OF STANDARD


This system has 4 components or elements and they are applied within your business management:

a. Management responsibility b. Resource management c. Product realization d. Measurement, analysis and improvement


THE REGISTRATION PROCESS


Registration is provided by organizations known as “Registrars”

Perform a third-party audit of organization

Successful audit yields registration recommendation

Registration is maintained through periodic “surveillance” audits


PROCESS APPROACH


INPUT PROCESS OUTPUT

Every Process Has An Owner


THE PROCESS BASED QUALITY MANAGEMENT SYSTEM


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STRUCTURE


Clause 1 Scope Clause 2 Normative references Clause 3 Terms and definitions Clause 4 Quality management system Clause 5 Management responsibility Clause 6 Resource management Clause 7 Product realization Clause 8 Measurement, analysis and improvement


CLAUSE 4.2 QMS DOCUMENTATION REQUIREMENTS


4.2.1 General - QMS documentation includes:

– documented statements of quality policy and objectives

– documented procedures “required” by the standard including: Control of Documents (Clause 4.2.3), Control of Quality Records (Clause 4.2.4), Internal

Audits (Clause 8.2.2), Control of Nonconforming Product (Clause 8.3), Corrective Action (Clause 8.5.2), and Preventive Action (Clause 8.5.3).

– other documentation as required by the organization for effective operation and control of its processes (including other procedures, process maps, flow

charts, work instructions, and other internal and external documents as required or appropriate).



4.2.2 Quality Manual - the quality manual must:

– include documented procedures or reference to them,

– describe QMS processes and their interactions, and

– define scope of the QMS with details and justification for any exclusions.




4.2.3 Control of documents - – documents must be approved prior to use, and periodically reviewed,

updated and re-approved– correct documents must be available where they are needed, legible,

identifiable and retrievable– obsolete documents must be removed from points of use and clearly

marked if retained– external documents must be identified and controlled

4.2.4 Control of records - – documented procedure for the identification, storage, retrieval, protection,

retention and disposition of records needed to provide evidence of conformity and effective operation of the QMS



CLAUSE 5 MANAGEMENT RESPONSIBILITY


5.1 Management commitment - top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness through specific activities:

– communicate importance of meeting customer (and regulatory/legal) requirements

– establish quality policy and objectives– conduct management reviews

– ensure availability of necessary resources



5.2 Customer focus - in addition to commitment to specific activities, top management must:

– ensure customer needs and expectations are determined, turned into requirements, and that those requirements are met

– customer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a “perception” that must be measured

per Clause 8.2.1)




5.3 Quality policy - this clause follows on from the general requirements for top management and requires them to establish quality policy that:

– is appropriate for the organization’s purpose,– includes a commitment to meeting requirements and continually improving

the QMS by:

> establishing and periodically reviewing the quality policy for continuing suitability,

> establishing and reviewing measurable quality objectives for achievement, and

> communicating policy and objectives at appropriate levels throughout the organization




5.4 Planning - This clause has two parts:

– 5.4.1 Quality objectives. Measurable quality objectives consistent with the quality policy must be established at relevant functions and levels in the

organization, including those needed to meet product requirements (identified per Clause 7.1 a); and

– 5.4.2 Quality management system planning. Resources required to meet the objectives and carry out the processes (identified per clause 4.1)

must be identified and planned




5.5 Responsibility, authority and communication - This clause has three parts:

– 5.5.1 Responsibility and authority. Responsibilities and authorities must be defined and communicated with the organization.

– 5.5.2 Management representative. An individual with responsibility for ensuring the QMS is implemented must be appointed, reporting to top management on performance of the QMS and ensuring awareness of

customer requirements is promoted throughout the organization

– 5.5.3 Internal communication. Finally, top management must ensure processes are established to communicate effectiveness of the QMS.




5.6 Management review -

– 5.6.1 General. Top management must review the suitability, effectiveness, and adequacy of the QMS at planned intervals; and must evaluate the need

for change, including changes to policy and objectives.

– 5.6.2 Review input. Specific review inputs are required including performance trends related to audit results, customer feedback, product

conformance, process performance, changes that could affect the QMS, and status of actions taken, as well as recommendations for improvement.

– 5.6.3 Review output. Decisions and actions as well as resource needs to carry them out must be documented.




6.1Provision of resources - determine and provide resources needed to implement and improve the QMS

6.2 Human resources -

– 6.2.1 General. People whose work affects conformity to product requirements must be competent - based on appropriate education, training,

skills and experience.

CLAUSE 6 RESOURCE MANAGEMENT



– 6.2.2 Competence, training and awareness.

Determine needed competencies, provide training or take other appropriate action to satisfy these needs, maintain training/qualification records, evaluate the effectiveness of actions taken to achieve the

necessary competence; and ensure employees are aware of the importance of their activities and how they contribute to achieving

quality objectives




6.3Infrastructure – plan, acquire and maintain the facilities (buildings, workspace, utilities, process equipment, hardware and software) and support services (transportation, communications, information systems) needed to achieve product conformance

6.4 Work environment - determine and manage the work environment (heat,

humidity, light, airflow, ergonomics, hygiene, cleanliness, noise, vibration, pollution, safety/protective equipment) needed to achieve product conformance




7.1Planning of product realization - covers the overall quality planning process (such as project management and advanced quality planning activities).Planning of realization processes must be:

> consistent with other requirements of the organization’s QMS> documented in a form suitable to the organization’s operations

In planning realization process, the organization must:> determine quality objectives for the contract, project or product

> determine the need for processes and documentation> define verification/validation activities and acceptance criteria (may require

customer approval) > define records to provide process and product conformity> determine and provided needed resources and facilities

CLAUSE 7.1 PLANNING OF PRODUCT REALIZATION



7.2.1 Determination of requirements related to the product

– customer specified requirements– requirements necessary but not specified– regulatory and legal requirements

7.2.2 Review of requirements related to the product

– requirements clearly defined and (unwritten requirements confirmed)– ensure ability (or confirm feasibility) of meeting all requirements before

acceptance of work– record results of review and follow-up

CLAUSE 7.2 CUSTOMER-RELATED PROCESSES



7.2.3 Customer communication

implement arrangements for customer communications related to:> product information,

> inquiries,> order handling,

> customer feedback, including complaints, and> Other communication requirements (such as electronic data interchange

capability, etc.)

CLAUSE 7.2 CUSTOMER-RELATED PROCESSES



7.3.1 Design and development planning7.3.2 Design and development inputs7.3.3 Design and development outputs7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation7.3.7 Control of design and development changes

CLAUSE 7.3 DESIGN AND DEVELOPMENT



Requires determination of:–stages of the process–required review, verification, and validations at each stage–responsibility and authority for these activities

Interfaces between groups involved must be managed

Essentially, establish design plans and keep them up to date

CLAUSE 7.3.1 DESIGN AND DEVELOPMENT PLANNING


CLAUSE 7.3.2 DESIGN AND DEVELOPMENT INPUTS


Define and document requirements:

– functional/performance (such as performance specifications and special characteristics to be controlled)

– regulatory/legal (such as environmental and governmental requirements)– information (experience) gained from previous designs– other essential requirements (may include targets for product quality, life, reliability,

durability, maintainability, timing and cost)

Review inputs

Resolve incomplete, ambiguous or conflicting requirements



Document in a format that allows for comparison with input requirements

Output shall:– meet input requirements– relate to product acceptance criteria– define characteristics essential to safe and proper use

Output may include:– Product definition (including drawings)– Design FMEA, product special characteristics, and product error proofing and

design review results, as appropriateApprove output documents prior to release

CLAUSE 7.3.3 DESIGN AND DEVELOPMENT OUTPUTS



Systematic review(s) at suitable stages in the design process:

– evaluate ability to meet requirements– identify problems and propose follow-up

Include representatives of functions concerned with the design

Record results of reviews and follow-up

CLAUSE 7.3.4 DESIGN AND DEVELOPMENT REVIEW



7.3.5 Design and development verification:

– ensures design output conforms to requirements– record verification results and follow-up

CLAUSE 7.3.5 DESIGN AND DEVELOPMENT VERIFICATION



7.3.6 Design and development validation:

– confirm product is capable of meeting the intended use (by pilot run or prototype program, for example)

– where practical, complete prior to product release– record validation results and follow-up

CLAUSE 7.3.6 DESIGN AND DEVELOPMENT VALIDATION


CLAUSES 7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES


Identify, document and control changes

Evaluate the effect of changes on:

– other parts of the product (i.e. other parts or software)– delivered products

Verify and validate the changes, as appropriate

Record results of change review and subsequent actions


CLAUSE 7.4 PURCHASING


7.4.1 Purchasing process

– control to ensure purchased product conforms to requirements– type and extent of control to depend on effect of subsequent processes and

their output– define supplier selection and periodic re-evaluation criteria– evaluate and select suppliers based on ability to meet requirements– record results of evaluations and follow-up



7.4.2 Purchasing information

– purchasing documents must include approval/qualification requirements for product, procedures, processes, equipment and personnel - as well as quality system requirements

– ensure adequacy of purchasing information prior to release

7.4.3 Verification of purchased product

– identify and implement receiving inspection or other activities to ensure incoming product meets quality requirements - and provide for verification and release at the supplier’s premises, if applicable




7.4.2 Purchasing information

– purchasing documents must include approval/qualification requirements for product, procedures, processes, equipment and personnel - as well as quality system requirements

– ensure adequacy of purchasing information prior to release

7.4.3 Verification of purchased product

– identify and implement receiving inspection or other activities to ensure incoming product meets quality requirements - and provide for verification and release at the supplier’s premises, if applicable



CLAUSE 7.5 PRODUCTION AND SERVICE PROVISION HAS FIVE MAJOR SUB-CLAUSES


7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceabililty

7.5.4 Customer property

7.5.5 Preservation of product


CLAUSE 7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION


Control production/service operations through:

– Information on product/service specifications (and product quality control plans, as appropriate)

– Work instructions as needed (for job set up and operator monitoring, for example)

– Suitable equipment (through preventive maintenance and tooling management programs, for example)

– Use of monitoring and measuring equipment– Monitoring activities (including operator monitoring information and feedback of

information from servicing) – Defined process for release, delivery and post-delivery (servicing) activities, as

applicable.


CLAUSE 7.5.2 VALIDATION OF PROCESSES


Validate processes where output cannot be verified prior to delivery

Demonstrate production and service processes can achieve planned results

Define controls, as applicable:– define criteria for review and approval– qualification of process and/or equipment– use of procedures and other defined methods– requirements for records– re-validation


CLAUSE 7.5.3 IDENTIFICATION AND TRACEABILITY


Establish and maintain suitable identification throughout production as appropriate

Identify measuring and monitoring (inspection) status of product

Record unique identification where traceability is a requirement


CLAUSE 7.5.4 CUSTOMER PROPERTY


Exercise care with customer property under the organization’s control:

– identify, verify, protect and maintain– record and report loss or damage to customer property

Applies to all customer property (not just customer supplied product), considerations include:

– customer provided product– customer owned tooling, equipment and facilities– customer provided intellectual property


CLAUSE 7.5.5. PRESERVATION OF PRODUCT


Preserve conformity of product during processing and delivery including:

– identification– handling– packaging– Storage (including stock assessment and inventory management control as

needed)– protection during delivery to the intended destination

Control extends to constituent parts


CLAUSE 7.6 CONTROL OF MONITORING AND MEASURING DEVICES


Control, calibrate and maintain measuring and monitoring devices used to assure conformance of product and service; measurement carried out in a way consistent with requirements

Where applicable, equipment must be:

– calibrated at intervals using traceable devices; record calibration results– adjusted as necessary– protected from damage and deterioration– identified to determine calibration status

Take action if suspect product or material has been shipped

Confirm ability of monitoring and measurement software prior to use


CLAUSE 8.1 MEASUREMENT, ANALYSIS & IMPROVEMENT - GENERAL


Define, plan and implement measurement, monitoring activities to:

– demonstrate conformity to product requirements

– assure conformity of the system

– achieve improvement of system effectiveness

Determine need for and ensure the proper use of “applicable methodologies” including statistical techniques


CLAUSE 8.2 MONITORING & MEASUREMENT


8.2.1 Customer satisfaction

8.2.2 Internal audits

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product



Monitor customer perception as to whether the organization has met requirements

The organization defines the methods and measures for obtaining this information

CLAUSE 8.2.1 CUSTOMER SATISFACTION



Periodic audits to determine if the QMS:– has been effectively implemented and maintained– conforms to the standard and other applicable quality management system

requirements

Planned audit frequency based on:– status and importance of activities/areas– results of prior audits

Planned scope and methods based on:– type of audit (system, process, product or function)– prescribed methods (including the use of checklists)– objective and impartial audit process (auditors must not audit own work)

CLAUSE 8.2.2 INTERNAL AUDIT


CLAUSE 8.2.3 MONITORING & MEASUREMENT OF PROCESSES


Apply measures to processes (especially production processes) as necessary to:

– meet customer requirements– demonstrate process capability– ensure continuing ability to satisfy its intended purpose– enable timely process adjustments as needed to prevent or minimize

nonconforming product

Measures become an input to improve processes



Apply suitable measures to characteristics of products to verify the requirements for the product are met

Maintain records to:

– provide evidence of required measurement, monitoring and conformance– indicate authority responsible for release of the product

Release product only after all activities completed

CLAUSE 8.2.3 MONITORING & MEASUREMENT OF PRODUCT


CLAUSE 8.3 CONTROL OF NONCONFORMING PRODUCT


Identify and control nonconforming product to prevent unintended use or delivery

Correct nonconforming product and re-verify to demonstrate conformity and/or authorized use (may require the organization to obtain customer waiver or deviation permit)

Take appropriate action regarding consequences of nonconformity found after product is delivered or is in use


CLAUSE 8.4 ANALYSIS OF DATA


Collect appropriate quality and operational performance data as needed to:

– determine suitability and effectiveness of the QMS– identify opportunities for improvement

Analyze trends (and compare to progress against established objectives) as needed to develop recommendations and prioritize actions leading to improved:

– Customer satisfaction– Product conformance– Process performance– Supplier performance


CLAUSE 8.5 IMPROVEMENT


8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action



Facilitate continual improvement through:

– quality policy– objectives– audit results– analysis of data– corrective and preventive action– management review

CLAUSE 8.5.1 CONTINUAL IMPROVEMENT



Take corrective action to eliminate causes of nonconformities

Corrective action taken must be appropriate to the impact of the problem encountered

Procedure required to:– identify nonconformities– determine causes– evaluate need for action (prioritize)– implement needed action– record results of action– review to ensure action is effective

CLAUSE 8.5.2 CORRECTIVE ACTION



Take preventive action to eliminate causes of potential nonconformities

Preventive action taken must be appropriate to the risk (i.e. impact of the potential problem)

Procedure required to:– identify potential nonconformities and causes– evaluate need for action (prioritize)– determine and implement needed action– record results of action– review to ensure action is effective

CLAUSE 8.5.3 PREVENTIVE ACTION

WCH Professional Services, LLC

(570)350-9256

WCH - We Can Help!

[email protected]

CALL US TODAY FOR A CONSULTATION

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