Standard Operating Procedure

Subcontracting of Testing and Calibration

This is an example of a Standard Operating Procedure. It is a proposal and starting

point only. The type and extent of documentation depends on the process environment.
The proposed documentation should be adapted accordingly and should be based on
individual risk assessments. There is no guarantee that this document will pass a
regulatory inspection.

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STANDARD OPERATING PROCEDURE Page 2 of 7
Document Number: S-522 Version 1.xx
Subcontracting of Testing and Calibration

Company Name:

Controls:

Superseded Document N/A, new

Reason for Revision N/A

Effective Date March 1, 2012

Signatures:
Author I indicate that I have authored or updated this SOP according to
applicable business requirements and our company procedure:
Preparing and Updating Standard Operating Procedures.
Name: ________________________________
Signature: ________________________________
Date: ________________________________

Approver I indicate that I have reviewed this SOP, and find it meets all
applicable business requirements and that it reflects the
procedure described. I approve it for use.
Name: ________________________________
Signature: ________________________________
Date: ________________________________

Reviewer I indicate that I have reviewed this SOP and find that it meets all
applicable quality requirements and company standards. I
approve it for use.
Name: ________________________________
Signature: ________________________________
Date: ________________________________

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STANDARD OPERATING PROCEDURE Page 3 of 7
Document Number: S-522 Version 1.xx
Subcontracting of Testing and Calibration

1. PURPOSE

When a laboratory subcontracts work, either because of unforeseen reasons (e.g.,

workload, need for further expertise or temporary incapacity) or on a continuous
basis (e.g., through permanent subcontracting), this work should be placed with a
competent subcontractor. This SOP guides user firms through the assessment
process.

2. SCOPE

Subcontracting testing and calibration of laboratories operating in FDA and

equivalent international environments, and/or operating under ISO 17025 and
equivalent quality systems.

3. GLOSSARY/DEFINITIONS

Item Explanation
Work Testing and/or calibration.

Note: For other definitions, see www.labcompliance.com/glossary.

4. REFERENCE DOCUMENTS

N/A

5. RESPONSIBILITIES

5.1. Process Owner

5.1.1. Leads the subcontracting process.

5.1.2. Defines the test and calibration requirements and acceptance criteria.

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Document Number: S-522 Version 1.xx
Subcontracting of Testing and Calibration
5.1.3. Communicates the status to the client.

5.2. Quality Assurance

5.2.1. Assists the project owner on quality system related questions.

5.2.2. Leads the process to audit the subcontractor, if necessary.

5.3. Laboratory Management

5.3.1. Defines the need for subcontracting.

5.3.2. Defines a process owner for subcontracting.

5.3.3. Provides resources to assist the project owner on technical questions.

5.4. Laboratory Staff and Supervisors

5.4.1. Assist the project owner on technical questions.

5.4.2. Randomly review work done by the subcontractor for technical quality.

6. FREQUENCY OF USE

6.1. Before subcontracting work.

7. PROCEDURE

7.1. Subcontracting Initiation

7.1.1. The laboratory gets a request from the client to perform a specific work,
e.g., specific type and number of tests.

7.1.2. The laboratory supervisor responsible decides that the work cannot be
performed because of limited resources, either technical or personnel.

7.1.3. The laboratory supervisor determines a project leader for possible

subcontracting.

7.1.4. The project leader describes the work to be subcontracted such that a
decision can be made to go ahead and subcontract or reject the work.

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Document Number: S-522 Version 1.xx
Subcontracting of Testing and Calibration
The description includes:

 Type and number of samples.

 Technical requirements.

 Rough return on investment.

7.1.5. Management makes a decision to subcontract the work based on

business opportunity and resources.

7.1.6. The project leader informs the client about the proposal to subcontract
the work.

7.2. Identification of the Subcontractor

7.2.1. The project leader makes a proposal for the selection of the
subcontractor, preferably from a list of authorized subcontractors.

7.2.2. If there is no authorized subcontractor for the work the proposal is based
on the reputation of the subcontractor, anticipated technical competence
and accreditation status, e.g., ISO 17025.

7.2.3. The project leader calls a meeting with management and QA and makes
a final decision on the priority list.

7.2.4. If the candidate is not an authorized supplier, QA leads the process for
assessment following the order of the priority list as defined in 7.2.3.

Assessment criteria are:

 Implemented quality system.

 Technical competence.

 Financial competitiveness.

The company that first meets the assessment criteria will be selected as
subcontractor.

7.2.5. The project leader informs affected parties within the company about the
selection process, the justification and the final decision on the
contractor.

7.3. Definition and Agreement of the Work

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Subcontracting of Testing and Calibration
7.3.1. The project leader describes the work in detail, e.g.,

 Responsibilities of the subcontractor.

 Equipment.

 Test procedures.

 Quality control procedures.

 Regulatory requirements.

 Acceptance criteria.

 Deliverables.

 Suggested time schedule.

 Price expectations.

7.3.2. The subcontractor evaluates and agrees or disagrees with the proposal.

7.3.3. If necessary, the project leader arranges for a meeting with the
subcontractor representative to agree on open issues including pricing
and timing.

7.3.4. The subcontractor confirms in writing that the company;

 Clearly understands the requirements as described in 7.3.1 and

agreed in 7.3.3.

 Has the expertise and resources to perform the work in the time
frame.

7.4. Conduct of Work

7.4.1. The project leader arranges for shipment of the test samples or
calibration items.

7.4.2. The subcontractor performs the work and sends the results to the project
leader.

7.4.3. The project leader compares the results and other deliverables with the
description in 7.3.1.

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Subcontracting of Testing and Calibration
7.4.4. The project leader summarizes the project, the findings and the
recommendations to improve future projects, if necessary.

7.4.5. The project leader presents the results to the client.

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