What is control plan in Quality


Quality Glossary Definition: Quality plan

A quality plan is a document, or several documents, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define:

  • Objectives to be attained (for example, characteristics or specifications, uniformity, effectiveness, aesthetics, cycle time, cost, natural resources, utilization, yield, dependability, and so on)
  • Steps in the processes that constitute the operating practice or procedures of the organization
  • Allocation of responsibilities, authority, and resources during the different phases of the process or project
  • Specific documented standards, practices, procedures, and instructions to be applied
  • Suitable testing, inspection, examination, and audit programs at appropriate stages
  • A documented procedure for changes and modifications to a quality plan as a process is improved
  • A method for measuring the achievement of the quality objectives
  • Other actions necessary to meet the objectives

At the highest level, quality goals and plans should be integrated with overall strategic plans of the organization. As organizational objectives and plans are deployed throughout the organization, each function fashions its own best way for contributing to the top-level goals and objectives.

At lower levels, the quality plan assumes the role of an actionable plan. Such plans may take many different forms depending on the outcome they are to produce. Quality plans may also be represented by more than one type of document to produce a given outcome.

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Elements of a Strategic Quality Plan

Quality Plan Example

An example of a quality plan is a manufacturing company that machines metal parts. Its quality plan consists of applicable procedures (describing the production process and responsibilities), applicable workmanship standards, the measurement tolerances acceptable, the description of the material standards, and so forth. These may all be separate documents.

More variable information that pertains to a particular customer may be spelled out on individual work orders (sometimes called travelers). Work orders specify the machine setups and tolerances, operations to be performed, tests, inspections, handling, storing, packaging, and delivery steps to be followed.

An operating-level quality plan translates the customer requirements (the what) into actions required to produce the desired outcome (the how) and couples this with applicable procedures, standards, practices, and protocols to specify precisely what is needed, who will do it, and how it will be done. A quality control plan may specify product tolerances, testing parameters, and acceptance criteria. While the terminology may differ, the basic approach is similar for service and other types of organizations.

How to Write a Quality Plan

Quality assurance or quality control plans evaluate and/or modify an organization’s procedures to help ensure they provide the desired results. Quality control plans are often viewed as a set of instructions that should be followed. They document the planning, implementation, and assessment procedures for a project, as well as any QA or QC activities.

Some areas may be more detailed than others, based on the project, process, or organization’s needs. It is important to note that each plan is unique based on the organization’s needs and their quality management system (QMS). However, quality control plans should always have a structure that permits improvements to the plan. This allows employees to offer input on how to improve efficiency and quality. In addition, the plan should be reviewed by others periodically, including stakeholders, to ensure the plan is comprehensive.


Three Elements of a Quality Plan

Quality control plans generally include detailed information on:

  • An overview or introduction of the project or process detailing the background, need, scope, activities, and important dates or deadlines
  • The organizational structure or org chart detailing necessary team members, including external vendors
  • Each team member’s responsibilities and qualifications necessary to fulfill stated duties
  • Work verification (e.g., who is responsible for carrying out a task, as well as who is responsible for checking the work)
  • Supplier standards (e.g., specify the standards the prospective suppliers must meet before they can bid on a contract, such as ISO 9001:2015)
  • A list of qualified suppliers
  • Testing parameters
  • Performance standards and how performance will be documented
  • Acceptance criteria
  • Deliverables
  • A feedback mechanism for internal and/or external customer feedback
  • Quality control procedures
  • Audits
  • Training (e.g., overview, job-specific, or refresher training)
  • Corrective action and preventive actions, including the person(s) responsible for CAPA
  • Suggested corrective action
  • Required notifications
  • Any references or related materials, including performance ratings or performance reports

Quality Plan Documentation and Deployment

Quality plans result from both deployed strategic quality policies (which are linked to organizational strategic plans) and from the specific legal regulations, industry standards, organization policies and procedures, internal guidelines, and good practices needed to meet customers’ requirements for products or services.

Strategic-level quality plans are developed and deployed through the strategic planning process. These broad-based quality plans become the guideline for each function’s or department’s supporting quality plan. Where appropriate, each function or department may develop and internally deploy operating-level quality plans.

Operating-level quality plans often are the resulting document(s) from a production scheduling function. As such, this documentation often includes blueprints, a copy of the customer’s order, references to applicable standards, practices, procedures, and work instructions, and details on how to produce the specific product or service.

When the product or service is produced, the planning documents may be augmented by inspection documentation, statistical process control (SPC) charts, and copies of shipping documents and customer-required certifications. In the process, the plans are transformed from documents to records. In a fully computerized system, the documents mentioned may well be interactive computer screens accessed at operators’ workplaces and control points. These screens, internally, become records when operators, inspectors, shippers, and others make computer entries to the screens.

A completed set of matrices, developed by a quality function deployment (QFD) process, may fulfill a component of an organization’s quality plan. The purpose of QFD is to capture and deploy the customers’ needs and requirements throughout the organization.

Documenting the quality plan(s) has multiple uses, such as:

  • Ensuring conformance to customer requirements
  • Ensuring conformance to external and internal standards and procedures
  • Facilitating traceability
  • Providing objective evidence
  • Furnishing a basis for training
  • Together with multiple plans for the organization’s products, services, and projects, providing a basis for evaluating the effectiveness and efficiency of the quality management system (QMS).

Adapted from The ASQ Certified Manager of Quality/Organizational Excellence Handbook, ASQ Quality Press.

The Control Plan is a written document that describe the methods & processes needed  for controlling the manufacturing of products (starting from raw material procurement to finished product shipment).

The Control Plan Quality gives the operator or inspector the knowledge necessary for proper process control and the production of high-quality components or products.

Control Plan is one of the important document of Production Part and Approval Process (PPAP).

Process Flow Chart (PFC) & Process Failure Mode Effect Analysis (PFMEA) are most important documents/elements of PPAP, and both are the direct source of inputs for making the control plan.

It is very important to note that the process/operation sequence number of control plan should be aligned with PFC & PFMEA sequence number.

Control Plan is a living documents that should be periodically review & updated for the following cases:

  • Implementation of corrective actions against the customer complaints, when applicable.
  • When there is any change occurs that affecting products, production process, measurements, supply chain, & failure mode effect analysis (FMEA).
  • At a defined frequency set as per customer requirement or based on risk analysis.

Control Plan Definition

Defination as per IATF 16949: Control Plan is the documented description of the systems and processes required for controlling the manufacturing of products.

Types of Control Plan | Phases of the Control Plan

Control plan is prepared in three phases:

  • Phase 1- Prototype Control Plan
  • Phase 2- Pre-launch Control Plan
  • Phase 3- Production Control Plan

Prototype Control Plan:  Prototype control is a  description of dimensional measurements, material, and performance tests that will occur during a prototype development. The organization shall have a prototype control plan, if required by the customer.

Pre-launch Control Plan: Pre-launch control plan is a description of dimension measurements, materials, and performance tests that occur after the completion of prototype phase and before regular production begins.

Pre-launch is defined as a production phase in the process of product realization that may be required after prototype build.

Production Control Plan:  This level of control plan include complete listing of the product and process characteristics, the process controls, tests, and measurement systems that occur during the mass production or routine production.

Control Plan Format | Control Plan Elements

A control plan quality format includes the following general data/contents/elements: 

  1. Control Plan Phases (Prototype, Pre-Launch, Production)
  2. Control Plan Number
  3. Issue date and revision date, if any
  4. Part Number(s)
  5. Core Team or CFT
  6. Part Name/Description
  7. Latest Engineering Change Level
  8. Key contact
  9. Organization’s name/Plant or site designation
  10. Functional area responsible
  11. Part/process step number
  12. Process name/operation description
  13. Machine, Device, Jig, Tools for manufacturing etc.
  14. Product control characteristics: Includes product & process description with reference number – a)  Number b) Product c) Process
  15. Classification- symbols used for special characteristics that are critical to quality (CTQs), & critical to process (CTPs). 
  16. Methods: A system or methods (includes inspection methods & tools, procedures, and work instruction etc.) for controlling the products and processes.
  17. Product/Process Specification/Tolerance
  18. Evaluation/Measurement Technique
  19. Sample Size & Frequency
  20. Control Method: The control methods includes but are not limited to visual inspection, SPC, mistakes proofing,  data collection etc.
  21. Reaction Plan: includes action plans (containment & corrective actions) against the nonconforming products & avoiding re-occurrence.

Control Plan Key Points

The organization shall address the followings key points while making the control plan for manufacturing of quality product:

  • The Control Plan (CP) includes all process stages from receiving to shipping.
  • The Control Plan steps are keyed to the to the Process Flow Chart and FMEA sequence numbers.
  • All special characteristic identification and technical requirements are met in the Control Plan.
  • The CP includes, or references, the relevant process control parameters.
  • The CP includes error proofing as appropriate.
  • The CP includes suitable sample sizes and frequencies.
  • The CP is subject to periodic review and update.
  •  The control plan includes the reaction plan for what to do if a non-conformance is found.

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