SDLC Tailoring

SDLC Tailoring

Accepting the statements that “One size does not fit all” and “It worked the last time does not ensure that it will work this time” provides the basis for effective process tailoring. Process and procedures need to be adapted using a common sense approach to address your current organizational situation, including the activities that add value and/or are required are addressed and removing activities that do not add value and are not required. Care must be taken during tailoring to maintain compliance with existing regulations and guidance. SEAS personnel are skilled in revising, verifying and validating internal policies, procedures, work instructions and external directives.

• Tailoring and applying the guidance provided by 21CFR§820, ISO13485, ISO14971, IEC 62304, IOS 9001, CMMi and other Regulated Processes and Best Practices

• Providing you with a dynamic maintainable roadmap that not only makes strategic sense but also results in exceeding customer expectations

• Implementing/Revising use of “Lessons Learned” • Policy/Procedure analysis and revision • Implementing/updating of Policy and Procedure Update Matrix

Cost of Quality The Cost of Good Quality is composed of the resources expended creating and delivering a product or service free of defects, not including the costs of resources expended associated with re-conducting processes necessitated by a defect identified at any stage, including on-market. The Cost of Quality (Good and Bad) is composed of the Cost of Good Quality plus the Cost of Poor Quality (the resources associated with re-conducting processes). Our goal is to decrease the Cost of Quality to as close as realistically possible, to The Cost of Good Quality. SEAS Consultants will use the following process to quantify your “Costs” and determine the resource effective actions necessary to decrease the Cost of Bad Quality closing the gap between The Cost of Quality and The Cost of Good Quality.

Cost of Quality = Cost of Good Quality + Cost of Bad Quality

• Determine Planned SDLC Quality Activities • Decompose Activities to:

o Frequency o Contributors o Hourly Rate of each Contributor o Man Hours for each Contributor o Cost of each Contributor

• Record Planned Time Estimates of Good Quality activities o Calculate Cost of each Good Quality activity o Calculate SDLC Good Quality activity cost

• Historically determine Actual Time of Actual Activities (Good & Bad) o Calculate Cost of each activity o Calculate SDLC Activity cost

• Analyze Planned Good Quality Activity Cost vs. Actual (Good & Bad) Activity Cost • Review Out of sync Planned vs. Actual Activity Processes • Revise Processes as necessary

Risk Management (current or new programs/projects) SEAS Consultants use a “Common Sense, Cross Functional Approach” to developing and formalizing or revising as necessary your organizations Risk Management documents. Risk documents, both process and product are started early in the process and are living through out. All risk controls and mitigations are validated and revised as necessary during the life of a project.

• Identifying and categorizing potential risks • Weighting all risks in an assessment matrix • Identifying each probability, consequence and mitigation • Conducting and documenting your Risk Benefit Analysis • Defining and Developing the monitoring of:

o Trigger Points o Responses o Follow-up Actions

• Updating and Maintaining your Risk Management Plan

Tool Validation (Custom and COTS)

Ensuring that your development and reporting tools function as you expect is vital to the success of your organization. SEAS Consultants are experienced in defining requirements, authoring plans and protocols and protocol executing and reporting.

• Requirements Identification • Risk Assessment • GAMP5 Analysis • Protocols for IQ, OQ, PQ

o Development o Trace Matrix o Execution o Protocol Reports o Report Summary

• Revalidation Criteria • Training • Implementation

Visit www.seas-inc.us to see a complete list of capabilities. Services can be performed on-site, off-site or a combination of on-site and off-site. Please contact me for rates and availability. Charlie Gragg (C) 760.470.2419 (O) 760.666.2914 Email: [email protected] Website:  www.seas-inc.us