This document outlines the specific quality issues that must be addressed by all BAPFOL Accredited laboratories to both attain and maintain their Accredited standing. Each Accredited facility must create their own Quality Manual that addresses each of the issues outlined within this Quality Document. Their specific laboratory manual becomes the basis for guiding that facility in all quality-related areas, and also forms the basis for the BAPFOL site audit that must be performed once every five years in order to maintain an Accredited standing.
BAPFOL Quality Standards Document:
This Board for Accreditation of Prescription Foot Orthotic Laboratories document specifies standards for both quality and production systems within a given laboratory by setting parameters for design, manufacture and supply capability.
The primary purpose of the specified procedures is to minimize non-conformity at all stages from design to servicing of professional foot orthoses.
This BAPFOL standard is applicable when:
a. The design of the custom foot orthoses and their functional modifications are stated principally in a submitted professional prescription.
b. The prescribed device is to meet requirements for design, developments, production and servicing.
2.0 For the purpose of this BAPFOL standard, a custom foot orthosis is the result of activities and processes including hardware, "software", "processed materials" and service in any combination as it applies to prescription foot orthoses.
3.0 Quality System Requirements:
3.1 Management Responsibility:
This document recognizes that management (or a given segment of management with responsibility to quality) shall define and document it's policy for quality including objectives for quality and commitment to quality. The quality policy shall be relevant to the laboratory's organization and its goal while taking into consideration the expectations and needs of its professional clientele. The lab shall take steps to have its policy understood, implemented, and maintained at all levels of the organization.
3.1.2 Those personnel who verify the quality of work performed shall have their responsibility and authority defined and documented, particularly for those personnel who need freedom and authority to:
a. Initiate action to limit the occurrence of non-conformity of custom foot orthoses, process or quality system.
b. Identify and record non-conformity of custom foot orthoses, process or quality system.
c. Initiate or provide solutions through designated channels.
d. Verify the implementation of solutions.
e. Control further processing, or stop delivery of non-conforming custom foot orthoses until the unsatisfactory condition is corrected.
The Lab will provide adequate resources and trained personnel for the management and verification of processes, product and materials.
188.8.131.52 Management Representation:
Each lab shall appoint at least one member of its executive management as a quality representative who is to be responsible for quality and shall have
a. Ensure that quality systems and quality procedures are established, implemented and maintained in accordance to this standard.
b. Report on the performance of the quality system to the lab's management. This forms a basis for improvement of the quality system.
c. Act as a laison with external bodies on matters relating to the lab's quality system.
3.1.3 The labs management with executive responsibility for quality shall review the quality systems at defined intervals to determine whether there is compliance with this standard as well as the lab's stated quality policy and objective (see 3.1.). Records shall be maintained, and held for internal review.
3.2 Quality System:
Lab shall establish, document and maintain a quality system to ensure that it has the capability to produce custom foot orthoses that meet the specifications of the original prescription. The outline structure shall be documented in a quality manual which includes and/or references the documented procedures of the quality systems.
3.2.2 Quality Systems Procedures:
The Lab shall:
a. Document procedures consistent with this standard and the labs stated quality system.
b. Implement the procedures and quality system.
The degree of documentation shall be dependent upon the methods used, skills needed, and the training required in the various activities of the Lab.
3.2.3 Quality Planning:
The Lab shall define and document, in a format suitable to its method of operation, how the requirements for quality will be met. This quality planning will be consistent with ongoing quality systems and procedures within the lab. The Lab shall consider the following activities, as appropriate:
a. The preparation for quality plans. These plans may directly reference the appropriate documented procedures of the Labs quality system.
b. The identification and acquisition of controls, processes, inspection equipment, fixtures, and total production resources and skills needed to achieve the required quality capability.
c. Monitoring the compatibility of the design, the production process,
installation and test procedures and the applicable documentation.
d. The updating as necessary of quality control, inspection and testing
techniques, including the development of new instrumentation.
e. The identification of suitable verification at various stages in orthotic production.
f. The clarification of standards and procedures including those which contain a subjective element.
g. The identification and preparation of quality records (see 3.13)
3.3 Contract Review (Prescription):
The lab shall have documented procedures to review the incoming professional prescription and for the coordination of subsequent activities.
Each accepted professional prescription shall be reviewed by the lab to
a. The requirements are adequately defined and documented.
b. Any/and all requirements of the professional prescription are contradictory.
c. The lab has the capability to meet the requirements of the professional prescription.
3.3.3 Amendment to the Professional Prescription:
The lab shall have procedures to determine that amendments or corrections to the professional prescription are made as necessary, and that such amendments are provided to the proper section(s) of the laboratory to fill the amended professional prescription.
Records of professional prescriptions shall be maintained (see 3.13). Channels for communication with all medical professionals shall be established and may include any or all of the following: fax, phone and mail.
3.4 Document and Data Control:
The lab shall establish and maintain procedures to control all documents & data pertaining to the professional prescription for a period of no less than three (3) years. This may be in the form of hard copy, electronic, or direct file as desired.
The lab shall have documented procedures for determining whether purchased product meets specifications.
3.5.2 Evaluation of Suppliers:
The Lab shall:
a. Evaluate and select suppliers based on their ability to meet supply requirements and on the ability of that purchased material to meet the quality standards of the lab.
b. Define as necessary the type and extent of the control exercised by the lab over the suppliers. This shall be dependent upon the type of material, the impact of the supplied material on the quality of the foot orthoses, and on the lab's quality records of the suppliers previous capability and performance.
c. Establish and maintain, as necessary, quality records of acceptable subcontractors.
3.6 Control of Supplied Material:
The lab shall establish and maintain documented procedures for verification,
storage and maintenance of supplied material that is part of the lab's inventory.
Any supplied material that is damaged or unsuitable for use shall be documented & quaranteened.
3.7 Process Control:
The lab shall identify and plan the production and processes directly affecting
quality and carry out those processes under controlled conditions. Controlled conditions include:
a. Documented procedures defining the manner and specifications of production where the absence of such procedures could adversely affect quality.
b. Use of suitable production, installation and servicing equipment, suitable working environment.
c. Compliance with reference standards/codes, quality plans and/or
documented procedures as appropriate.
d. Monitoring and control of suitable processes and parameters as well as material & orthotic characteristics during production.
e. The approval of process and equipment as appropriate.
f. Criteria for workmanship will be stipulated by written standards, representative sample, or illustration.
g. Suitable maintenance of equipment to ensure continuing quality capability.
h. Any process which cannot be verified by subsequent inspection or testing shall be carried out by qualified personnel to determine whether the lab standards are met.
3.8 Inspection and Training:
The lab shall establish and maintain documented procedures for inspection to determine whether the requirements for custom foot orthoses meet the requirements of the professional prescription.
The inspection, and maintenance of these records shall be in compliance with the quality plan and/or documented procedures.
3.8.2 Final Inspection:
The lab shall carry out a final inspection to determine whether the foot orthoses complies with the standards of the quality plan and documented procedures as well as the professional prescription. No custom foot orthosis shall be dispatched until all activities of the quality plan and/or documented procedures have been satisfactorily completed and adequately documented.
3.8.3 Inspection Records:
The lab shall establish and maintain records demonstrating that the custom foot orthoses has been inspected and/or tested showing clearly that the device has passed or failed accepted criteria. When the custom foot orthosis fails to pass inspection or test, Section 3.10 (non-conforming product) applies.
3.9 Control of Inspection, Measuring & Test Equipment:
The lab shall establish and maintain procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by the lab to determine whether custom foot orthoses conform to the specified requirements of the professional prescription & the quality standards of the lab. Inspection, measuring and test equipment shall be used within an allowable range of measurement uncertainty.
3.10 Control of non-conforming custom foot orthoses:
The lab shall establish and maintain documented procedures to minimize use or shipment of non-conforming custom foot orthoses.
The lab shall provide for identification, documentation, segregation and disposition of non-conforming custom foot orthoses.
3.10.2 Non-conforming custom foot orthoses review and disposition:
The responsibility for review and authority for the deposition of non-conforming custom foot orthoses shall be defined.
Non-conforming custom foot orthoses shall be reviewed according to documented procedures and:
a. May be reworked to meet specifications
b. Rejected and scrapped.
Repaired and/or reworked custom foot orthoses shall be reinspected in accordance to the quality plan and/or documented procedure.
3.11 Corrective & Preventative Action:
The lab will establish and maintain documented procedures for implementing corrective and preventative action. Corrective and preventative action taken shall be appropriate to the magnitude of the problem and commensurate to the risk encountered. The lab will implement and record the resulting changes in the appropriate documents.
3.11.2 Procedures for Corrective Action shall include:
a. Effective handling of customer complaints or other reports of deficient custom foot orthoses.
b. Investigating the cause of the deficient custom foot orthoses, process or quality system and recording the results.
c. Determining and taking, as necessary, the corrective action needed to eliminate the deficient custom foot orthoses.
3.11.3 Procedures for Preventive Action include:
a. The use of appropriate sources of information such as customer complaints, internal reports, quality records, service reports, evaluation of process and work operations.
b. Determining the preventive action needed.
c. Initiating preventive action.
d. All actions proposed and/or taken shall be submitted for management review.
3.12 Handling, Storage, Packaging, Preservation & Delivery:
The lab shall establish and maintain documented procedure for handling, storage, packaging and delivery of the custom foot orthoses.
The lab shall establish methods of handling product to minimize damage.
The lab shall establish methods for packing, packaging and marking orthoses, as necessary, to properly protect and maintain uniformity .
The lab shall have the capability to arrange for the protection of the quality of the custom foot orthoses from time of dispatch through to delivery at destination.
3.13 Control of Quality Records:
The lab shall establish and maintain documented procedures for identification, collections, access, filing, storage, and disposition of quality records. These records shall be maintained to determine effective use of, and conformance to, the quality system.
All quality records shall be legible, readily retrievable, in a form that is durable over time. Retention times of quality records shall be a minimum of one year. Quality records shall be made available for evaluation by the customer for one calendar year where agreed to contractually.
Records may be hard copy media, electronic media or paper media.
Personnel performing specific assigned tasks shall be qualified on the basis
of appropriate education, training and/or experience.
3.15 In order to service or repair a previously delivered custom foot orthosis, the lab will establish and maintain documented procedures for servicing these products in a manner consistent with the lab's quality standard.
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