Control of subcontractors

It is important that you inform the subcontractor through the contract of how the product or service will be accepted. Will it be as a result of receipt inspection at the specified destination or as a result of acceptance tests witnessed on site by your authorized representative These details need to be specified at the tendering stage so that the subcontractor can make provision in the quotation to support any of your activities on site. If you have invoked ISO 9001 in the subcontract, you are protected by clause 4.6.4.2. If you have not, you need to specify a similar provision in your subcontract, otherwise you may lose the right to reject the product later. There is no requirement for you to document your proposal to verify product at the subcontractor s premises but such a plan would indeed be a useful section in any quality plan that you produced. (See also Control of subcontractors in this chapter.)... 

Drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

It is not uncommon for a company to design a medical device prototype and then have it built by a company specializing in electronic manufacture. Where this happens, as in our case, a number of suitable companies should be considered for the project, and those shortlisted should be audited for capability. Selection would depend on the quality system in place, previous experience in medical device manufacture, control of subcontractors, level of testing supplied, and the amoimt of in-house technical support available. It is advisable to ensure that a legal agreement, Quality Plan, and User Requirements Specification (URS) are employed to secure production standards for the device. 

These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

Each of these processes is addressed in more detail below. Other important safety management processes that are not included here include operating and maintenance procedures, project quality assurance arrangements, the control of subcontractors, and security arrangements (including information technology security, as discussed in Chapter 3). 

The standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

Clause 4.6.2.1 requires that you define the extent of subcontractor control but neither this clause nor clause 4.6.4.1 requires you to plan, execute, or record any verification at... 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Prepare procedures covering the planning of subcontractor control activities. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

GR-6.2.2.3 Subcontractor Control. The subcontractor services shall be controlled by the processes of procurement, quality review, and surveillance, including receiving inspection, supported by the proper documentation. The subcontractor shall provide a Quality Control System (manual), documented procedures, and applicable work instructions. The construction organization shall be responsible for approval of all subcontract services. 

The use of subcontractors needs to be clearly understood well before the audit visit, together with the oversight planned by the prime supplier. If the prime supplier does not have adequate control over subcontractors, then Supplier Audits by the pharmaceutical or healthcare company may be... 

The Occupational Safety and Health Review Commission (OSHRC) initially addressed the employer-employee relationship shortly after the OSH Act was enacted in the case titled Gilles v. Cotting, Inc. In this case, two employees of the primary contractor were killed in an accident created by and resulting from the actions of a subcontractor. OSHA issued one citation to the primary contractor and one citation to the subcontractor. OSHA subsequently vacated the citation to the primary contractor, finding the citation was improper and would impose liability outside the employment relationship. Over the years, the OSHRC, as well as the various federal Circuit Courts of Appeal, has addressed this issue primarily in the construction area, with focus on creation of the hazard and control of the hazard. In recent decisions and with the inception of the multiemployer woiksite rule, the scope of the duty to safeguard employees at the worksite has been substantially expanded."... 

Manufacturing associated activities in terms of infrastructure design, such as controls, procedures, selection of subcontractors etc. that are involved in the main process aspects of manufacturing. 

Developing and implementing safe work practices to control the entrance, exit, presence, and accountability of subcontractors. 

Reqnire general contractors to supervise and control activities of subcontractors to promote patient safety. 

For Construction How does the written program provide for control of safety and health conditions for other contractors and subcontractor employees ... 

This multiemployer worksite doctrine first arose in the construction industry, where the presence of numerous contractors and subcontractors on one site sometimes made it difficult to determine who was responsible for safety violations. In response to this problem, OSHA established a rule that basically imposed responsibility on any employer who had control of the site. The rule has been and continues to be challenged in courts across the country, and recent rulings tend to support individual employer-employee responsibility. 

The three major OSHA standards most frequently cited to employers regarding contractor safety are Process Safety Management of Highly Hazardous Chemical (29 CFR 1910.110), Control of Hazardous Energy (Lockout/Tagout) (29 CFR 1910.147), and Hazard Communication Standard (29 CFR 1910.1200). These regulations pertain to the hiring of outside contractors and subcontractors to perform repair work, plant modification, equipment maintenance, etc. Many countries around the world have their comparable standards. 

Section 4 applies to persons in charge of premises where people work and who are not their employees. They must ensure that the premises, any plant (including the fixed electrical installation) and the means of ingress and egress are safely maintained. An obvious example of the application of this duty is a construction site where the main contractor is the person in charge and in control of the site and who is responsible, therefore, for ensuring that the site is safe for the subcontractors labour forces. 

A program shall be established to control measuring and test equipment when it is in the possession of the reactor maintenance department. The program shall also specify requirements for (1) M TE selection, (2) proper storage and control of M TE equipment in the reactor areas, (3) functional checks of the equipment prior to use, and (4) requirements to prevent the contamination of the M TE equipment. The program shall provide for actions taken to (T) return M TE equipment for calibration, (2) perform a timely assessment of M TE equipment usage when M TE equipment is found to be out-of-tolerance, and (3) control subcontractor-provided M TEs. This program shall be in accordance with the WSRC Quality Assurance Manual, IQ. ... 

Contractors and subcontractors are typically required by contract to be responsible for their own workers and should provide a level of oversight to meet all specifications. The primary contractor who is responsible for the worksite typically establishes the minimum requirements, controls access to the worksite, and verifies that subcontractors fulfill their health and safety duties and responsibilities. Wlien these specifications are defined, all contractors and subcontractors should meet or exceed these requirements, as appropriate. This could be based on the nature of the assigned tasks and associated hazards [2]. 

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