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ISO 9001 - Quality Planning Requirements

#1
Quality Planning in Element 4.2: Is Quality Planning something other than our documented procedures, forms, & the quality manual. I'm not sure I understand what exactly the ISO standards mean by Quality Planning. I would take it to mean our documented procedures, forms, & the quality manual. I'm I correct in assuming this?
 
A

Alf Gulford

#2
That's the same stand we tried to take but were written up during the pre-assessment for failing to define and document how we comply with Quality Planning.

As a result, we now have 2 large procedures that describe how we handle both design projects and larger company issues. These describe the various phases, deliverables, team structures, etc. Although they're well thought out, we haven't had any large projects to really put them through the wringer yet. The registrar likes them but experience tells me that the larger and more detailed the procedure, the less likely it is that people will follow it.

I don't recommend this route unless you're forced into it and would really like to hear about other's experiences.

Alf
 

CarolX

Super Moderator
Super Moderator
#3
MRW,

Yes, your procedures are part of your quality planing. But other areas may affect your quality plan. For example...during contract review, does your customer have any specific requirements that are not standard? Does Engineering need to aquire new tooling or equipment to provide the customer what they ordered? Is there additional employee training required to perform the work to be done? I addressed quality planning as an engineering procedure since our engineering department is the first to review all new orders receved from customers.

Hope this helps....
Carol
 

Marc

Captain Nice
Staff member
Admin
#4
Some excerpts from various sources:
****************************

NOTE: Initial Quality planning is addressed during the ‘Implementation’ phase of a project (see Appendix A, Page 4). However, XXXX believes quality planning is an ongoing process and is one of the responsibilities of the Process Improvement Manager to oversee, and serve as liaison for, within the company.

Even Management Reviews play a role in planning (changing resource needs considerations, etc.) and as a source of continuous improvement inputs. The Process Improvement Manager liaisons with all functional areas in regard to changes to process controls (inspections and tests) as well as master system changes.

Departmental managers are continually reviewing feedback from processes, including ‘inspections and tests’, to identify potential sources of nonconformances. Outputs from this every day process can effect changes and/or additions to current inspections and tests as they relate to planning. Also see 7.1, 7.5.1, 8.1 and 8.2.4 herein.

Sample Procedure:

QP 4.2.3 QUALITY PLANNING

QP 4.2.3.1 GENERAL

Quality Planning is an integral part of the Quality System. As noted in QM 4.2.3, Quality Planning addresses the provisions of the Quality Standard 4.2.3. by defining and documenting the requirements for quality and describes the procedures to accomplish these requirements. This Plan documents the procedures and methods of operation and it conforms to the basic format as illustrated in the Advanced Product Quality Planning reference manual, following the ongoing principle to Plan, Do, Study and Act and repeat as appropriate. This cycle illustrates the never-ending pursuit of continual improvement that is achieved by applying the experiences learned in one situation to the next situation.

The Quality Plan results from a Management decision to provide documented evidence of the processes involved to accomplish the Company Mission and Quality Policy in order to provide the customers with quality products.

QP 4.2.3.1 a SCOPE

The Quality Plan documents, in detail, the process of handling parts from the point of receipt of the parts through to shipping. The documentation follows the format of the Advanced Product Quality Planning reference manual so as to assure compliance with MIL-I-45208 Inspection System Requirements and/or Customer Requirements.

QP 4.2.3.1 b RESPONSIBILITY

The Process Control Plan is prepared by the Quality Assurance department in conjunction with various other departments, under the direction of the Quality Planning Team and the Management Representative. The Quality Planning Team functions as a cross-functional team representing Purchasing, Customer Service, Quality Assurance, Engineering and Warehouse operating personnel.

Efforts of the Quality Planning Team are augmented by the Continuous Improvement Team consisting of Customer Service, Quality Assurance, the Controller, Warehouse operations and members of Senior Management.

QP 4.2.3.1 c APPLICABILITY

The Business Plan provides the framework for the Quality Planning process and establishes constraints in the development of the Process Control Plan.

Terms and definitions used in the Process Control Plan are explained in Section 3 of the Quality Manual, supplemented by industry specific reference manuals on file in the Quality Assurance department. The Process Control Plan is continually monitored and updated to reflect changes in processes or customer requirements.

In addition to Special Characteristics (both customer defined and Company X defined), the Process Control Plan is geared to address the "Voice of the Customer" as it pertains to compliments, complaints, and recommendations resulting from customer quality audits and subsequent problem resolution reports. Customer input is also solicited by interviews, surveys and questionnaires.

QP 4.2.3.1 d STANDARD COMPLIANCE

Company X compliance with the QS9000:1998 includes the Process Control Plan and Failure Mode and Effects Analysis (FMEA). FMEAs are part number specific.

When special characteristics are identified on the customer design record, they are appropriately identified within production documentation to indicate those process steps that affect the special characteristics.

Company X may identify special characteristics other than customer specified characteristics.

QP 4.2.3.2 SPECIAL CHARACTERISTICS

Company X's process control guidelines (FMEAs, Control Plans, Work Instructions) identify 'Special Characteristics' to indicate the process steps that affect these Special Characteristics. Special Characteristics may be customer defined in the design record, may be identified by Company X, or may be a combination of both. Special Characteristics may be identified from any product characteristic category including dimensional, material, appearance, performance and process requirement.

QP 4.2.3.3 FEASIBILITY REVIEWS

Company X investigates and confirms the manufacturing feasibility of proposed products prior to contracting to produce those products. Feasibility is an assessment of the suitability of a particular design, material or process for production, while conforming to all engineering requirements at the specified volumes and the required statistical process capability.

Feasibility reviews are documented using the Team Feasibility Commitment in the Advanced Quality Planning and Control Plan reference manual.

QP 4.2.3.4 PRODUCT SAFETY

Due care and product safety is considered in process control (element 4.9) policies and practices. Company X promotes internal awareness of safety considerations relative to the product.

QP 4.2.3.5 PROCESS FAILURE MODE and EFFECTS ANALYSIS

Company X FMEAs consider all Special Characteristics. Efforts are taken to improve processes to achieve defect prevention rather than defect detection.

QP 4.2.3.6 MISTAKE PROOFING

Company X utilizes appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling.

QP 4.2.3.7 CONTROL PLAN

The Process Control Plan is designed to define and document the requirements for quality from the point parts enter the warehouse until the final point of shipment to the customer. The Process Control Plan is consistent with the detailed process procedures contained in the elements of the Quality Manual and is documented to meet specific requirements of customer operations. The control plan includes the information required in the Control Plan form in QS9000:1998 Appendix J, address process controls and complies with the requirements of the AIAG APQP reference manual. The control plan is multi-disciplinary in origin and are updated when appropriate in accordance with QS9000:1998 4.2.3.7 'The Control Plan'.

The Process Control Plan identifies specific quality processes, resources and the sequence of activities applied to assure quality application from the point of receiving to shipment to the customer. Traveling status cards and Accept Tags are used to control the flow of products through the various activities. The Process Control Plan includes the process of qualifying new products and/or new applications; as well as monitoring the quality of products on a lot by lot basis, to satisfy customer requirements. This feature is an integral part of our strategy to provide customer satisfaction and obtain customer confidence. This process is key to developing new business.

QP 4.2.4 PRODUCT APPROVAL PROCESS

Company X fully complies with all requirements set forth in the Production Part Approval Process (PPAP) manual.

QP 4.2.4.2 SUBCONTRACTOR REQUIREMENTS

Company X ensures subcontractors utilize a defined part approval process.

QP 4.2.4.3 ENGINEERING CHANGE VALIDATION

Company X ensures that engineering changes are appropriately validated as required by contract with consideration to QS9000:1998 sections 4.12 and 4.16 and in consonance with the Production part Approval Process manual.

QP 4.2.5 CONTINUOUS IMPROVEMENT

QP 4.2.5.1 GENERAL

A continuous improvement philosophy is deployed throughout Company X's operations in consonance with QS9000:1998 section 4.2.5. Continuous improvement extends to product characteristics with the highest priority on Special Characteristics.

Company X develops prioritized action plan(s) for continuous improvement in processes which have demonstrated stability, acceptable capability and performance.

QP 4.2.5.2 QUALITY and PRODUCTIVITY IMPROVEMENTS

Company X identifies opportunities for quality and productivity improvements and implements appropriate improvement projects in consonance with QS9000:1998 section 4.2.5.2.

QP 4.2.5.3 TECHNIQUES for CONTINUOUS IMPROVEMENT

Company X utilizes continuous improvement techniques which are appropriate for Company X's products and processes in consonance with QS9000:1998 section 4.2.5.3.

QP 4.2.6 FACILITIES and TOOLING MANAGEMENT

QP 4.2.6.1 FACILITIES, EQUIPMENT and PROCESS PLANNING EFFECTIVENESS

Company X utilizes a multi-disciplinary approach for developing facilities, processes and equipment plans in conjunction with the advanced quality planning process. Plant layout maximizes material flow and handling, facilitates synchronous material flow and maximizes value added use of floor space. Methods are developed for evaluating the effectiveness of existing operations and processes with consideration to:
1. Overall work plan
2. Appropriate automation
3. Ergonomic and human factors
4. Operator and line balance
5. Storage and buffer inventory levels
6. Value added labour content

Appropriate metrics are defined to monitor the effectiveness of existing operations.

QP 4.2.6.2 TOOLING MANAGEMENT

Company X has a system for tooling management in consonance with QS9000:1998 section 4.2.6.2.

Refer to QF 4.2.3.1 and QF 4.2.3.2
 
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