Understanding the Value of a Gap Analysis

When a Life Science organisation doesn’t know if they are making the best use of their resources, capital and technology – and possibly aren’t – an operation may not be able to achieve an acceptable level of compliance, efficiency or productivity. This is where a Gap Analysis from ZES can help.

A Gap Analysis undertaken by ZES is an important tool that can aid any Life Science organisation with their performance management. During the Gap Analysis process, ZES will enable the Life Science organisation to determine their current level of performance and then set their goals for their future performance. ZES has helped many Life Science organisations to re-examine their goals to understand their projected road to achieving an effective, efficient and compliant operation.

A Gap Analysis can assist all Life Science organisations, from large blue chip corporations to small businesses and start-ups. There are no limits as to which areas of a Life Science organisation's operation could benefit from using a Gap Analysis. These areas include the following:

• Quality Control
• Quality Assurance
• Efficiency
• Compliance
• Production Activities
• Maintenance Activities
• Project Management

A ‘gap’ found by ZES during a Gap Analysis in the Life Science sector could be from any of the above categories.

ZES will generally complete four steps during the gap analysis process, ending in a Gap Analysis Report that identifies areas which ZES consider to be worthy of improvement, and will document suggestions, alongside an action plan, to implement gap remediation.

Once given the scope of the gap analysis, four basic steps are undertaken by ZES as detailed below:

• Step One: ZES will accurately outline and define the Life Science organisation goals or targets, all of which will be specific, measurable, attainable, realistic, and timely.
• Step Two: ZES will utilise historical data to measure the current performance of the Life Science organisation as it relates to its outlined goals.
• Step Three: ZES will analyse the collected data and understand why the measured performance is below the desired levels.
• Step Four: ZES will produce a report based on the data collected and provide potential reasons as to why the overall data is impacting on performance. Remediation action items will also be detailed in the report to aid the Life Science organisation to understand how they can achieve their goals identified in the report.

• No assurance provided by the Supplier for the services they supply
• Incorrect screenshots used as evidence in qualification test scripts
• Qualification tests not completed correctly (Good Documentation Practice)
• Project in qualification phase, without an approved URS or VP being approved by Quality
• Training provided not followed up with suitable support and expertise
• Quality signatures not present on URS
• Inappropriate Calibration tolerances eg 0-3 Bar gauge with tolerance of +/-1.5 Bar (half scale)
• Qualification performed by the Supplier with no Client witness present
• Lack of training for personnel performing Qualification testing
• Lack of training and experience of personnel reviewing technical documents
• No evidence of a project change control
• URS not being updated following a change to the system
• Uncontrolled spreadsheets used as evidence of qualification test scripts
• Test equipment not traceable
• Calibration certificates not to the required standard
• Equipment used for sterile filling with fundamental design concerns
• Lack of training records
• Validation personnel with little understanding of the standard  V-Model
• Raw data not recorded
• Project communications not recorded

Given the significance of some of the gaps found by ZES, to improve the situation a significant budget is sometimes not forthcoming. Some companies prefer to wait until the regulatory authorities make observations during an inspection, which unfortunately makes the Life Science industry far too reactive, in the view of ZES.

Ifyou think compliance is expensive, you really don’t want to experience the cost of non-compliance!