Difference between revisions of "SCC Quality System Manual (QSM)"
m (→(6.3) Maestro Business Support System)
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* Document the basic product concept in a project plan document according to the format given by [[SCC QSF Project Plan (PRP)]].
* Document the basic product concept in a project plan document according to the format given by [[SCC QSF Project Plan (PRP)]].
* Manage the project according to the [[SCC QSP Project Management]],
* Manage the project according to the [[SCC QSP Project Management]], the plan as .
=== (7.2) Customer Processes ===
=== (7.2) Customer Processes ===
Latest revision as of 17:01, 29 October 2018
This is the QSM (Quality System Manual) for the Swift Construction Company (SCC) Quality Management System (QMS). The SCC QMS is designed for compliance with ISO 9001:2008.
For additional information on the SCC Quality Management System, please contact:
Rad Sampson Director, Quality (Quality Management Representative) Swift Construction Company 1 Swift Way Shopton, NY 13054 USA Phone: 1 315 123-4567 Fax: 1 315 123-4568 Email: email@example.com
- 1 (1) General
- 2 (2) Company Background
- 3 (3) Definitions and Conventions
- 4 (4) Quality Management System
- 5 (5) Management Responsibility
- 6 (6) Resource Management
- 7 (7) Product Realization
- 7.1 (7.1) Planning of Product Realization
- 7.2 (7.2) Customer Processes
- 7.3 (7.3) Design
- 7.4 (7.4) Purchasing
- 7.5 (7.5) Operations
- 7.6 (7.6) Inspection, Measurement and Test Equipment
- 8 (8) Measurement, Analysis and Improvement
Providing clarity is a challenge for all organizations. Clarity is achieved by having agreement within an organization on fundamental drivers, and provides employees at every level with a common vocabulary and shared set of assumptions. Clarity enables employees to make decisions and resolve issues without escalating it or leaving a situation ambiguous (both of which reduce clarity).
Focus comes from clarity, achieved through trust and transparency.
The SCC QSM attempts to provide clarity of SCC business, goals and procedures for SCC employees, vendors, customers and other stakeholders.
Objectives of the SCC Quality Management System, and of this manual, include:
- Consistency of new product development.
- Consistency of product quality.
- Compliance with regulatory and statutory requirements.
- Measurements of SCC Quality which enhance the Company's reputation with customers and vendors.
- Compliance with business process standards of interest to the SCC.
(1.1) Index and Revision Status
The paragraph numbering of the SCC QSM corresponds to ISO 9001:2008.
This manual is a maintained in electronic form as a living document. All other copies, in whatever form, are uncontrolled and not updated.
(1.2) Purpose and Scope
The purpose of the QSM is to document the SCC's quality management system (QMS). The scope of the QSM is all aspects of the SCC's business.
Requirements of ISO 9001: 2008 which can not be applied for some reason will be noted as exclusions. An ISO 9001: 2008 requirement may be excluded only when both of the following conditions have been met:
- the requirement must be within ISO 9001 clause 7, Product Realization, and
- the exclusion may not affect our ability, nor absolves us from the responsibility, to provide product that meets customer and applicable regulatory requirements.
The Quality Director is responsible for identifying any ISO 9001 requirements that do not apply and to propose exclusions of such requirements from the scope of the SCC Quality Management System. The President is responsible for approval of exclusions. Exclusion review and approval are conducted by a management review.
There are no exclusions.
(2) Company Background
(2.1) Company Activities
The Swift Construction Company (SCC) is a small to medium enterprise (SME) carrying on the business of high-tech product design, manufacturing and sales, and with a typical headcount, revenue, and profit. The SCC possesses proprietary advanced technologies, including electronics micro-miniaturization, non-human intelligence, wireless communications, and spacecraft propulsion. The SCC follows industry best practices, and strives to achieve transparency with trust for all company information.
(2.2) Company History
- The Swift Construction Company (SCC) was founded by Barton Swift as an engineering design services and construction contract company.
- SCC acquired Cyberdyne Systems. The acquisition expanded the SCC manufacturing operations and brought expertise in microprocessor and non-human intelligence technologies.
- SCC acquired Yoyodyne Proplusion Systems. The acquisition brought advanced spacecraft propulsion technologies, including the revolutionary Rocketship 1 space exploration platform.
- SCC implemented Maestro as a business support system and immediately realized significant improvements in clarity and effectiveness of work practices, human resource efficiencies, increased accuracy and control over critical information, quality of decision making, dramatic cost reductions and increased employee satisfaction.
(2.3) Company Purpose
- The Swift Construction Company (SCC) is first and foremost a provider of extreme engineering design and product manufacturing services ("engineer to order").
- The SCC manufacturers and sells products associated with maintenance programs for provided product engineering services ("make to order").
- The SCC manufactures and sells a small number of standard products ("make to stock")
- The SCC's moto is "Excellence in Innovation".
(3) Definitions and Conventions
(3.1) Definitions and Terminology
- The Quality Director is responsible for creating and maintaining a list of acceptable terminology for use in SCC activities, including definitions and acceptable abbreviations. All controlled documents shall adhere to this list when created or derived. Documents need only conform to terminology accepted at the date the document was created and/or maintained.
- Refer to SCC QSR Terminology.
(4) Quality Management System
(4.1) General Requirements
The Company has established, documented, implemented and maintains to its best effort and ability a Quality Management System (QMS) in accordance with the requirements of ISO 9001: 2008. The company continually improves the effectiveness of its QMS.
The Company's Quality Management System (QMS):
- Identifies the processes needed for its operations and their application.
- Determines the sequence and interaction of the processes.
- Determines criteria and methods needed to ensure that both the operation and management of the processes are effective.
- Ensures the availability of resources and information necessary to support the operation and monitoring of the processes.
- Ensures monitoring, measurement and analyses of the processes.
- Ensures implementation of actions necessary to achieve planned results and continual improvement of the processes.
The company manages these processes in accordance with the requirements of ISO 9001: 2008.
SCC exercises control over outsourced aspects of its business through applicable operational processes. Refer to Section 7.4 Purchasing.
(4.2) Documentation Requirements
Information critical to the successful operation of the SCC is documented in the SCC Wiki, according to the SCC QSP Wiki Articles. In general, a philosophy of Transparency with Trust is preferred over one of secrecy.
- Critical information is information upon which decisions are based.
- Transparency means the history or background of critical information is available.
- Trust means that the information has not been altered or manipulated in a way that is not visible.
Controlled documents of the SCC Quality Management System (QMS) are:
- The Quality System Manual (QSM) describes how one follows the SCC Quality Management System (QMS), and for all purposes is the instruction manual for SCC operations.
- A Quality System Procedure (QSP) is directly referenced by the QSM and describes a set of actions to accomplish a particular goal within the scope of the QSM.
- A Quality System Record is evidence proving compliance with the QSM or execution of a QSP.
- A Quality System Form (QSF) describes data required to be captured by the QSM or a QSP. A QSM may be a template for storing data, and the "completed" QSM becomes a QSR (e.g. a paper form or spreadsheet). The following forms shall be used to create new documents as indicated:
The following diagram shows the relationships between these documents.
/--> QSR | QSM --+--> QSP --+--> QSR ^ |--> QSF | \--> QSP --\ | | \----------------/
- The QSM references QSRs and QSPs, which in turn reference QSFs, QSRs, and lower-level QSPs. Note the QSM can reference QSRs directly, which means the QSM is effectively the top-level QSP.
- A QSP can require QSRs for demonstration of compliance.
- A QSP can reference documents outside the scope of the SCC Quality System for additional detail (e.g. a work instruction).
All records are retained for a minimum of 2 years.
(5) Management Responsibility
SCC delegates authority to employees so that they can operate autonomously within the scope of their assigned responsibilities. SCC strives to make decisions at the lowest management level at which both authority and responsibility for all reasonable aspects of the decision reside. SCC employees are held equally responsible for the identification and documenting of non-compliance's and opportunities for improvement.
(5.1) Management Responsibility
SCC management is responsible for:
- establishing a quality policy and quality objectives.
- defining and communicating responsibilities and authorities necessary to facilitate effective quality management.
- establishing quality objectives at relevant functions and levels, that are measurable and consistent with the quality policy, and include those objectives needed to meet product requirements.
- performing periodic management reviews, including periodic review of the quality management system
- inputs to the management review are explicit and must include audit results, feedback from customers, process performance and product conformance analysis, preventive and corrective actions status, follow-up actions from previous management reviews, and any changes that might affect the quality management system.
- outputs from the management review include actions relating to improvement of the quality management system (and its processes), product improvement (related to customer requirements) and resource needs.
- the management review must be used to evaluate the need for changes to the quality management system, quality policy and quality objectives.
- records of management reviews must be kept.
- providing evidence of their commitment to ensure the availability of appropriate resources.
- defined and communicating responsibilities and authorities of employees
- ensuring customer needs and expectations are determined and fulfilled.
- promote awareness of customer requirements throughout the organization.
(5.2) Customer Focus
The SCC depends on its customers and must understand current and future customer needs to succeed. The SCC strives to meet customer requirements and exceed their expectations.
When deemed to be of sufficient importance, SCC QSP Contract Review process shall be followed to ensure a customer’s needs are fully understood and can be met by the SCC with acceptable risk and return to both parties.
(5.3) Quality Policy
SCC is committed to providing customers with products and services that satisfy their requirements. The primary objectives of SCC's quality policy are customer satisfaction and a commitment to continual process improvement. These objectives drive the SCC's growth and return on investment.
SCC's quality policy is: "To meet requirements and exceed expectations at the least possible cost."
This Quality Policy is reviewed with management at the opening of each Management Review Meeting, to all employees annually, and to new employees as a component of their orientation. The Quality Policy is also displayed prominently in SCC work areas and wherever appropriate in SCC internal, customer, and end-user publications.
(5.4) Quality System Planning
The QMS has been planned and implemented to meet SCC quality objectives and the requirements of ISO 9001 Section 4.1. Quality
Quality objectives are established to support the SCC's efforts in achieving its quality policy, and are reviewed annually for suitability. Quality objectives are measurable, with the results reviewed against performance goals at each management review meeting. The Quality Director is responsible for maintaining documented quality objectives.
Refer to SCC QSR Quality Objectives.
(5.5) Organization and Communication
The following chart shows the internal organization of the SCC.
Swift Construction Company President +-- Engineering | +-- Electronics Hardware Engineering | +-- Mechanical Engineering | +-- Software Engineering | \-- Engineering Project Management +-- Product Management | \-- Technical Writing +-- Sales & Marketing +-- Manufacturing | +-- Purchasing | +-- Receiving | \-- Production Planning +-- Director, Finance | +-- Accounts Payable | \-- Accounts Receivable +-- MIS & IT +-- Legal +-- Quality \-- Human Resources
The Executive Steering Committee provides strategy and oversight, and is made up of senior management. Decisions are carried by majority vote of a 2/3 quorum of committee members. The President holds veto authority when less than 100% of the Executive Steering Committee members vote.
(5.6) Management Review
Management review of the suitability and effectiveness of the Quality Management System (QMS) take place at least twice per year. During the management meetings actions are allocated and minuted to record the development of the Company's management system.
The objectives of Management Review are:
- To establish that the QMS is achieving the expected results and meeting the SCC's requirements, continuing to conform to ISO 9001:2008, continuing to satisfy customers needs and expectations, and functioning in accordance with established quality management procedures.
- To expose irregularities or defects in the QMS, identify weaknesses and evaluate possible improvements.
- To review the effectiveness of previous corrective actions, and to review the adequacy and suitability of the management system for current and future operations of the Company.
- To review any complaints received, identify the cause and recommend corrective action if required.
- To review the finding of internal/ external audits and identify any areas of recurring problems or potential improvements.
- To review the reports of nonconforming items and trend information to identify possible improvements.
Internal audits of the QMS shall be undertaken at least once per year to confirm functionality meets user expectations and needs, and that the QMS Manual is being adhered to by users. Non-compliance's of either type must be documented in Maestro's Corrective Action System.
(6) Resource Management
(6.1) Provision of Resources
Managers shall be responsible for proposing resource which they believe are necessary to satisfy business objectives.
(6.2) Human Resources
The Executive Steering Committee shall approve all employee positions, consistent with:
- approved internal structure of the business
- description of responsibilities for the position
- assigned Compensation Grid Level for the position
The HR Director shall maintain a chart of approved positions and responsibilities in SCC QSR Employee Functions, and ensure that 1) there is a vacant approved position before an offer of employment is made, and 2) there is an approved position for each employee.
The HR Director shall maintain a Compensation Grid, and shall ensure all positions are assigned an appropriate grid level when approved based on defined responsibilities, including consistent title and compensation level, and that all employees conform to the Compensation Grid.
TODO add compensation grid in Maestro Document Control
The HR Director shall maintain a list of current employees in the SCC QSR Employee List.
Employment candidates shall be interviewed by the hiring manager and preferably also by at least one employee in a peer role. Depending on the position, the Executive Steering Committee may require an HR representative also interview the candidate before an offer of employment can be made.
Interviews should be based on a standard questionnaire, and the candidate scored immediately after the interview session by the hiring manager. Records shall be retained by the hiring manager until the candidate has been hired, but for a maximum time of one year after the interview.
TODO add "SCC QSF Candidate Interview Record (QSR)" in Maestro Document Control.
Employment candidates may be interviewed for positions which have not (yet) been approved by the Executive Steering Committee so long as the candidate is made aware of the situation before the interview, and that an employment offer cannot be made until the position has been approved.
If an offer for employment is accepted, the hiring manager shall notify the IT Director with the necessary information to assign a network ID, and a Security Profile according to the SCC QSR Maestro Security Profile Matrix".
The policy of the company is to ensure all employees receive appropriate training for their positions and responsibilities.
Managers shall identify training requirements for employees under their supervision according to the requirements and responsibilities of the position and the background of the employee.
Managers shall ensure employees meet the training requirements identified for their position.
The HR Director shall maintain a record of the training required for each position and employee.
The HR Director shall maintain a record of the training received by each employee, and its of degree of completion (i.e., complete/incomplete, pass/fail, letter grade or percentage grade).
The HR Director shall monitor employee training requirements and degree of completion, and notify employees and their managers of any discrepancies. Once notified, employees and their managers are responsible for the employee completing training in a timely manner.
(6.3) Business Support System
All significant aspects of the SCC operations are managed using Maestro, the SCC's Business Support System.
The MIS/IT Director shall maintain employee security profiles as documented in the "SCC QSR Maestro Security Profile Matrix", and ensure ensure employees have appropriate security profiles consistent with their responsibilities.
TODO add "SCC QSR Maestro Security Profile Matrix" in Maestro Document Control.
(7) Product Realization
An organization may externally present a single type of product, but internally there are likely many different types depending on the internal customer.
(7.1) Planning of Product Realization
- Document the basic product concept in a project plan document according to the format given by SCC QSF Project Plan (PRP).
- Manage the project according to the SCC QSP Project Management, refining the plan as required.
(7.2) Customer Processes
The Sales and Marketing Director shall maintain a list of significant customers - SCC QSR Customer List
Any goods received from a customer (e.g. a free issue item or equipment to be serviced) are visually inspected at receipt and any non-declared non-conformance shall be immediately reported to the customer.
All significant design activities are performed within the scope of an SCC project, documented according to the format given by SCC QSF Project Plan (PRP), and managed according to the SCC QSP Project Management.
Deliverables from the design process (i.e., product data) is captured according to the SCC QSP Product Lifecycle Management.
Vendors of products, materials and services, where unspecified by a customer contract, are selected on their ability to meet the company's requirements given due consideration to the quality, statutory obligations, timescale and cost.
Vendors are approved on the following basis:
- Previous performance in supplying to similar specifications and requirements.
- Stocking of high volume standard items conforming to a relevant British Standard, or supplied with a statement of conformity.
- Compliance with an approved third party product/ quality registration scheme.
- Recommendation by other similar purchasers or manufacturers of equipment.
- A trial order and evaluation of performance.
All supplies and sub-contracts are subject to an authorized Purchase Order providing full clarification of the type and extent of supply.
The Manufacturing Director shall maintain a list of significant vendors - SCC QSR Vendor List.
Handling, Storage, Packaging, Preservation and Delivery
The identification of materials/ equipment, where it is not obvious, is confirmed by the presence of a manufacturers/ suppliers part number or description label, or other marking for each item. The identification of the item may be on the packaging or on the item itself, and this identification remains in place for as long as possible, provided it does not hamper effective use of the item. Materials and consumables are not identified by the company where they are obvious to a trained/ experienced employee, however, should a risk of misinterpretation exist between two or more types of material these will be marked in a suitable manner to ensure that no ambiguity exists.
All items with serial numbers are recorded individually.
Materials and goods received, whether the property of the company or others, will, as far as practicable, be protected and their quality preserved until such time as they are transferred to a customer, or disposed of to a third party. The objective is to prevent deterioration and damage whilst in storage, or in the process of transportation, installation, commissioning or maintenance.
Indication of Inspection Status
As goods are inspected, the status is defined by location in stores, with all non-conforming items being placed in a reject area or marked as reject for review. The status of work in progress is established by markings or associated documentation recording the inspections undertaken and their acceptability.
All stores areas are maintained as secure as practical. All items received by the Company are identified and verified in accordance with the requirements of the Delivery Note and Purchase Order, and are inspected for correct identity, quantity and any signs of damage.
All goods received are documented and, in the event of non-conformance, the items are placed in a reject area or labelled to ensure identification. The extent of the non-conformance is noted and subject to disposition review by nominated personnel.
(7.6) Inspection, Measurement and Test Equipment
Production and measuring equipment held is maintained in good condition, and capable of safe and effective operation within a specified tolerance of accuracy. Test and measuring equipment is regularly inspected or calibrated to ensure that it is capable of accurate operation, by comparison with external sources traceable back to National Standards.
Electrostatic protection equipment is utilized when handling sensitive components, and this equipment is regularly checked to ensure that it remains fully functional.
(8) Measurement, Analysis and Improvement
TODO provide general details of measurement, analysis and improvement.
(8.1) Planning of Monitoring and Measuring
All productive work is planned and undertaken in accordance with the company's procedures, and any specific documents agreed for individual contracts (e.g. contract specifications).
Work instructions are provided by the agreed contract specification and any documents referenced therein, alternatively work is performed in accordance with nationally accepted codes of practice (e.g. BS6701).
(8.2) Monitoring and Measurement
Inspection and testing is carried out on completion of installation and maintenance activities, with results being documented. Should items not be acceptable against the agreed contract criteria they will either be repaired, replaced or identified for a subsequent evaluation and decision. All repaired items are subject to a re-inspection to ensure acceptability.
On completion of installation and maintenance works, the customer is also invited to check the work performed to ensure full acceptability.
(8.3) Control of Non-Conforming Product or Service
Once non-conforming items have been noticed they are identified by location, associated documents, or specific markings to prevent their inadvertent use. All non-conforming items and customer complaints are subject to review and rectification by nominated personnel. The type and extent of non-conformity is documented in order to establish trends and identify possible areas for improvement.
The corrective action required to prevent recurrence is evaluated, documented, and its effective implementation is monitored. All rectification is subsequently re-inspected to ensure complete customer satisfaction.
SCC QSP Control of Non Conforming Product shall be followed for matters relating to non-conforming material.
(8.4) Analysis of Quality Information
- TODO: PROVIDE GENERAL DETAILS OF QUALITY INFORMATION ANALYSIS
(8.5) Continual Improvement
- TODO: PROVIDE GENERAL DETAILS OF CONTINUAL IMPROVEMENT PROCESS