Attachment_2_QASP_2016.docx

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

ANIMAL GENOTYPING SERVICES

INTRODUCTION

This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the performance work statement (PWS) entitled Mouse Genotyping Stations Support Contract. This plan sets forth the procedures and guidelines the government will use in ensuring the required performance standards or services levels are achieved by the contractor.

Purpose The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the PWS, and to ensure that the government pays only for the level of services received.

This QASP defines the roles and responsibilities of all members of the integrated project team (IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

Performance Management Approach This QASP will monitor and manage the contractor’s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved.

Performance management represents a significant shift from the more traditional quality assurance (QA) concepts. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met.

Performance Management Strategy The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s own quality control (QC) program. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor will self-inspect the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS.

1.3.2 The government representative(s) will monitor performance and review reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The government will make determination regarding incentives based on performance measurement metric data and notify the contractor of those decisions. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

ROLES AND RESPONSIBILITIES

The Contracting Officer The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the contracting officer's representative (COR) and the contractor. The CO will designate a COR as the government authority for performance management.

The Contracting Officer’s Representative The COR is designated in writing by the CO to act as his or her authorized representative. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. The COR is responsible for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards and/or quality levels are included in the PWS and in Attachment 1, “Performance Requirements Summary.” Failure to meet the required service or performance level will result in a deduction from the monthly amount.

METHODOLOGIES TO MONITOR PERFORMANCE

Surveillance Techniques In an effort to minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are:

· Random monitoring.

· 100% Inspection.

· Periodic Inspection.

Customer Feedback The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.

Customer feedback may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.

Acceptable Quality Levels The acceptable quality levels (AQLs) included in Attachment 1, Performance Requirements Summary, for contractor performance are structured to allow the contractor to manage how the work is performed while providing negative incentives for performance shortfalls. Levels of performance are keyed to the relative importance of the task to the overall mission performance at NIEHS.

QUALITY ASSURANCE DOCUMENTATION

The Performance Management Feedback Loop The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the PWS and are assessed using the performance monitoring techniques shown in Attachment 1.

Monitoring Forms The government’s QA surveillance, accomplished by the COR, will be reported to the contractor using the monitoring form in Attachments 2. The form, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results are being achieved.

The COR will retain a copy of all completed QA surveillance forms.

ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

Determining Performance Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels. Failure to meet the AQL may result in a deduction from the monthly payment, using the deduction percentages shown in Attachment 1.

Reviews and Resolution The COR may require the contractor’s project manager, or a designated alternate, to meet with the COR and other government IPT personnel as deemed necessary to discuss performance evaluation. The agenda of the reviews may include:

· Monthly performance assessment data and trend analysis

· Issues and concerns of both parties

· Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis

· Recommendations for improved efficiency and/or effectiveness

· Issues arising from the performance monitoring processes

The COR and CO must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

The COR, CO and contractor may jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels will be clearly documented. Mutually agreed to changes to service levels, procedures, and metrics will be incorporated as a contract modification.

Attachment 3

PERFORMANCE REQUIREMENTS SUMMARY

Determine the genotype of animal samples for specific mutation or genetic alteration

100% of testing results are reported to the Government within 72 hours

Random, monthly monitoring of testing results.

Review of customer complaints.

30% deduction in the unit price for every genotype delivered after 72 hours. 100% reduction in the unit price for every genotype delivered after 96 hours.

Customer complaints exceeding 3 per month will result in a 10% deduction in the subsequent month’s total invoice price

Develop reproducible genotype assay(s)

90 % of all assay development info is submitted within 24 hours of written NIEHS request and acceptable on first submission to Government

100% of all assay development info is submitted within 24 hours of written NIEHS feedback and acceptable on subsequent submission to the Government.

30% deduction in the unit price for every genotype assay whose functionality is not tested within 96 hours.

100% reduction in unit price for every genotype assay developed which does not function as designed.

Any unauthorized release of data will result in a 50% deduction in the subsequent month’s total invoice price.

QUALITY ASSURANCE

MONITORING FORM

SERVICE or STANDARD:

Determine genotype Develop genotype assay Maintain confidential, secure data

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

Random Sampling 100% Inspection Periodic Inspection Customer Complaint LEVEL OF SURVEILLANCE (Check):

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Narrative of Performance During Survey Period:

PREPARED BY: ___________________________________ DATE: _________________