C-108
Redzone Administration Activities
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1.0 Purpose The purpose of this procedure is to define Redzone administration activities. 2.0 Scope This procedure applies to administration activities associated with Redzone. 3.0 Responsibility 3.1 It is the responsibility of all employees provided with permissions to use the RZ Admin application to adhere to the requirements of this procedure. 4.0 Definitions 4.1 RZ — Redzone; Mark Sutcliffe founded Redzone Production Systems in 2013. The company website is https://rzsoftware.com/ and provides additional information about the product. 4.2 RZ Admin — When written in bold and italic font, this is the Redzone backend application used to configure the system. 4.3 Redzone — When written in bold and italic font, this is the Redzone frontend user application. 4.4 Backend Application — The backend application provides tools to set user permissions, define locations to use RZ, define products and associated characteristics, define shifts, define data sheets, and define triggers. 4.5 Frontend Application — The frontend application provides the interface for using the RZ Software in the production environment. It is the end user interface. [SOP Standard Operating Procedure SOP No | Rev bie oes Redzone Administration Activities C-108 0 fee 4.6 Data sheet — Unless explicitly stated otherwise, a data sheet is an RZ component of the RZ Compliance Module that is configured in RZ Admin and used in Redzone to collect data. 4.7 Tableau — Tableau is an interactive data visualization software company / tool focused on business intelligence. The tool is used to query relational databases, online analytical processing cubes, cloud databases, and spreadsheets to generate graph-type data visualizations. 4.8 SPC — Statistical Process Control; a method of measuring and controlling quality by monitoring the manufacturing process. Quality measurements recorded in data sheets are evaluated against control statistical control rules to identify trends before data is out of specified limits. 49 Installation Qualification (IQ) — IQ verifies that equipment or a system is installed according to the manufacture’s specifications or installation checklist. 4.10 Operational Qualification (OQ) — OQ verifies that equipment or system performance meets all identified user requirements as defined in a URS document. OQ is performed after meeting all IQ requirements. 4.11 Performance Qualification (PQ) — PQ verifies that user requirements as defined in a URS have been verified similar to OQ. The difference is that PQ evaluates the system as a whole while OQ focusses on units individually. 4.12 Handwritten Signature — Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. 4.13 Biometrics — Biometrics mean a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those [SOP Standard Operating Procedure SOP No | Rev ae Redzone Administration Activities C-108 0 g features and/or actions are both unique to that individual and measurable. 4.14 Digital Signature — Digital signature means an electronic signature based upon cryptographic methods of originator authentication that is computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. 4.15 Electronic Record — Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. 4.16 Electronic Signature — Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. 4.17 eGMP-— Current Good Manufacturing Practices 5.0 References 5.1 C-105, SOP, Protocol and Report Documentation Requirements 5.2 C-403, SOP, Change Control Procedure 5.3 C-111, SOP, Redzone General Use 6.0 Procedure 6.1 Overview 6.1.1 Use the backend RZ Admin application to complete development activities associated with this procedure. Use the Redzone application to complete testing activities associated with this procedure. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 4 of 14 Redzone Administration Activities 6.2 RZ Knowledge Base 6.2.1 The Knowledge Base available in the Redzone application and the RZ Admin application both accessed through the “More” tab provides detailed information about navigating within the application and provides “how to” details to perform many of the functions described by this procedure, which is not necessary to repeat here. Consult the Knowledge Base as needed. 6.3 Verification of Product Characteristics 6.3.1 RZ provides the ability to assign product characteristics to products. Product characteristics are available to data sheets and provide a mechanism to test data entered into a data sheet against control and specification limits. Evaluate the connection of a data sheet to the proper characteristics during the PQ / Verification process of the data sheet. Verify that product characteristic values entered are correct for that product during the review and approval process for the applicable product documentation (e.g. product profile, test ticket, etc.). Include product characteristic verification documentation with those supporting documents (i.e. the initial approval documentation, or change control documentation) as applicable. 6.4 Design and Create Data Sheets and Triggers 6.4.1 There are three types of data sheets. The table below defines the behavior of each type: Included in Included in Sign Must be linked to a Data sheet Type Scoring method Quality Dashboard Off Dashboard production run Quality Check Pass / Fail Yes Yes Yes Production Check Pass / Fail No No No Audit Numeric Score No No No 6.4.2 Quality Check data sheets are associated with a production run and therefor a production batch. Quality Check data sheets include activities like a run startup check, a run process check, etc. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 5 of 14 Redzone Administration Activities 6.4.3 Production Checks are not associated with a run. These checks are independent of a specific production run or batch number and include activities like a scale daily check, equipment calibration, or an environmental monitoring check. 6.4.4 Audit data sheets are also independent of any specific production run or batch number. The key difference for Audit data sheets compared to the other two data sheet types, is that Audit data sheets provide a score when completed. 6.4.5 Create the appropriate type of data sheet to fit the needed function. Use control limits on fields when applicable. Use triggers to automate compliance with applicable procedures. Attachment 1 defines fields available for use within data sheets. Attachment 2 defines triggers available for use with data sheets. Review data sheets during the design phase to ensure compliance with applicable procedures. Procedures may need to include adoption of RZ data sheets into the process. 6.5 PQ Conditions 6.5.1 Installation Qualification (IQ) and Operational Qualification (OQ) of RZ validate the basic functionality of RZ and do not need repeating. Further Performance Qualification (PQ) documentation of the application of RZ to specific cGMP functions is dependent upon the complexity and purpose of the application. The following defines when a PQ report is required in a report as defined later in this SOP and when it is not. Note: PQ activities (i.e. verification that the RZ works as intended) is always required. Documentation of that verification is defined here. 6.5.1.1 A PQ Report is required only for automating a cGMP process by RZ. Automation includes: ® When RZ performs cGMP calculations [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 6 of 14 Redzone Administration Activities When RZ determines the outcome of a cGMP test (ie. checking results to Pass, warn, or Fail) When RZ schedules GMP work or performs a cGMP function and Jon trusts that schedule or work without any other safeguard to make sure that work or function happens (i.e. the automatic trigger of a data sheet based on specific events) 6.5.1.2 Ion Labs may choose to write a PQ report, but a PQ report is not required for the following applications of RZ: RZ data sheets used for non-GMP purposes RZ data sheets that only collect data (i.e. no automation) RZ data sheets that include automation, but that automation is not a cGMP requirements. For example, RZ triggers may provide alerts or messages that are for convenience, but are not a cGMP function. Minor modification of a previously verified RZ application (see further discussion on this topic later in this procedure). 6.6 RZ Process — PQ Steps 6.6.1. When creating or modifying RZ Compliance Components (i.e. data sheets, triggers, and/or reactions), always test and verify that they function as intended before deployment for cGMP activity use (i.e. complete PQ steps defined here). Note: This activity may require documentation in a PQ report as defined later in this procedure. Consider and address the following during PQ activities as applicable. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 7 of 14 Redzone Administration Activities 6.6.1.1 When possible, test new components using “RZ Test” components (1.e. areas, locations, products) rather than real components. 6.6.1.2 When using real components to test new components, add comments as applicable, indicating that the activity is for test purposes and not associated with real production activities. 6.6.1.3 For complicated trigger/reaction scenarios, be sure to test all applicable paths. For example, test passing, warning, and failing results if the triggers involved should behave differently under those conditions. 6.6.1.4 Test data sheets that connect to product characteristics to ensure that they connect as expected. 6.6.1.5 Test data sheets that contain calculations to ensure that formulas work as expected. 6.6.1.6 Consider the steps necessary to deploy the process in RZ. 6.6.1.7 Ensure that the RZ components align with the requirements of applicable procedures and regulations associated with the intended purpose. 6.6.1.8 Update procedure as necessary to provide operators with necessary instructions to use the RZ components. 6.7 Redzone PQ Report Requirements 6.7.1 Upon completion of PQ activities for a cGMP RZ process as defined in this procedure, complete a PQ report. The PQ report must include, at a minimum, the following features: 6.7.1.1 Assign a report number and comply with report requirements as defined in SOP C-105 Protocol and Report Documentation Requirements. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 8 of 14 Redzone Administration Activities 6.7.1.2 Reference this procedure as the source of PQ requirements for the report. 6.7.1.3 List all RZ components subject to the PQ. Cover any number of components in the same report as needed. It is best practice to group components into the same report by function, process, or purpose. 6.7.1.4 List procedures that the RZ components support. Verify that the functionality of the components align with procedure requirements. Procedures may need revision to accommodate RZ as part of the process. 6.7.1.5 Describe the RZ components and intended use. Flow charts are not necessary for simple PQs, but are best practice for complicated processes. 6.7.1.6 Describe the PQ steps used. It is not necessary to list every step in detail. Do include: 8 Who was involved in the PQ steps described and the dates the activities occurred. ® Provide enough detail to allow finding evidence of the steps taken within RZ as applicable. 6.7.1.7 It is not necessary to record screenshots to document PQ activities. 6.7.1.8 Describe the deployment plan as applicable. 6.7.1.9 Define at least two signatures on the report that indicate Done By and Verified By with regard to the PQ activities. At least one signature on the report must be a quality signature. 6.8 Modification to Previously Verified RZ Processes [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 9 of 14 Redzone Administration Activities 6.8.1 Major modifications to a previously verified application of RZ to a cGMP system require re-execution of the PQ process as described here. Minor modifications do not require re-execution. The discussion of PQ Conditions are a good definition of the intent of PQ as it applies to RZ. If the changes made fall into examples of a system that would require PQ, then re-execution is required. If not, the re-execution is also not required. The list that follows are examples of changes that would not necessarily require documented re- qualification: 6.8.1.1 Changes to test on a data sheet 6.8.1.2 Adjustments to triggers or data sheets to include new products or locations 6.9 RZ Test Components 6.9.1 RZtest...”” components exist in the live RZ system only for training and testing purposes. Some of these components require a username and password to create the component (i.e. Area, Location, or User Components). IT is responsible for managing all users and the RZtestUser account is disabled during normal operations. The username and password for Areas and Locations is available to allow a system login as an Area or Location. TRZ does not allow this login any administration privileges. Ion Labs does not use this feature. Do not distribute passwords for Locations or Areas. Do not distribute passwords for Locations or Areas. 6.10 Understanding Revision History in the RZ Admin Application 6.10.1 The revision history of components (i.e. people, places, products, shifts, data sheets, and triggers) in the RZ Admin application have a similar method of displaying revision history. The application stores revisions to these components under a revision section on the same screen where editing of these components occurs. The system groups changes based on the date and time the user saves the changes. A single header includes the revision number, the user that made the change and the date and time for the “save” event. Under that header are all the changes listed individually with a colored dot next to the change. The color of the dot has the following meanings: 6.10.1.1 Green dot = fields / values added [SOP Standard Operating Procedure SOP No Rev Page 10 of 14 C-108 Redzone Administration Activities 6.10.1.2 Red dot = fields / values removed 6.10.1.3 Orange dot = fields / values changed 6.10.2 Use revision history documented in RZ in conjunction with other system documentation (e.g. the initial approval documentation, or change control documentation) to investigate and confirm deviations, errors, and routine changes. 7.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 03/14/22 | New procedure. N/A K. Burris | - | - | 8.0 Attachments 8.1 Attachment | — Redzone Data Fields 8.2 Attachment 2 — Redzone Triggers and Reactions [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 11 of 14 Redzone Administration Activities Attachment 1 — Redzone Data Fields Table 1: Field Types Field Type Description Keyboard The user may enter text from the device keyboard. The user may enter text from the device keyboard; however, the format of the text entered must comply with a “mask” custom defined for the field. For Formatted Text example a mask of “(###) ###-####” would force a typical phone number format. A mask of “JON-####” would only allow a four-digit asset number with “ION-“preceding the asset number. Whole Number The user may enter a whole number. The user may enter a decimal number. This field allows the control of the Decimal Number number of digits store through the “Decimal Precision” option for the data field defined during datasheet design. Date (Day & Time) The user may enter a date and time Date (Day & Year) The user may enter a date without a time. Photo Allows the insertion of a photo taken from the device (iPad) in real time Allows the insertion of a photo taken from the device (iPad) in real time or a Photo or Camera Reel photo chosen from a previously taken photo Allows taking a scan of a barcode or QR code and will input the result into the Barcode field, Maven ast Allow selection from a list of options defined for a product characteristic. Option List Allow selection from a previously defined option list. Option lists are defined in the Redzone administration app. The user may enter a series of numbers. The field allows control of the count of numbers the user enters through a “Sample Size” setting for the field. An Numeric Sample Set “agoregation” setting for the field also defines an aggregation method as one of the following (Mean, Median, Mode, Max, Min, Sum, or Range). The user may define an expression. The expression may consist of other fields Expression on the datasheet and the functions defined in Error! Reference source not found.. This field is used in conjunction with a Numeric Sample Set field. The Secondary Test secondary test applied a different aggregation setting to the same data collected in the Numeric Sample Set field. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 12 of 14 Redzone Administration Activities Attachment 1 — Redzone Data Fields Error! Reference source not found. below defines functions available for use in a RZ Expression field type Table 2: Expression Functions Function Description Add (+) Addition Subtract (-) Subtraction Multiply (x) Multiplication Divide (+) Division ; Opening parentheses “(‘‘, and closing parentheses “)” may be used to control Parenthesis ; aan the order of operation within the expression. Maximum The maximum of values contained within the function Minimum The minimum of values contained within the function Mean The mean of values contained within the function Mode The mode of values contained within the function Range The range of values contained within the function Sum The sum of values contained within the function Product The product of values contained within the function Count The count of values contained within the function Reference Reference other data fields on the same data sheet. [SOP Standard Operating Procedure SOP No | Rev C-108 g | Page 13 of 14 Redzone Administration Activities Attachment 1 — Redzone Data Fields Error! Reference source not found. below lists options available for use with RZ fields. These options may be: ® Omitted & Applied specifically to the field in the datasheet, or ® Applied as a product characteristic specific to the product associated with the instance of the datasheet Table 3: Data Field Options Option Description This option defines the number of places after the decimal point that the Decimal precision system will use to evaluate this field against limits defined by the next rows of this table. The lowest value considered as a reasonable entry. Values lower than this will Lower Reasonable prompt the user that this may not be a reasonable. This limit may prevent limit entry errors. The lowest value allowed that still meets the specification. Values lower than Lower spec limit this will produce a FAIL status. The lowest value allowed that is in control. Values lower than this will Lower control limit produce a WARN status. The values may be set or based on SPC calculation. This represents the specification value. This may be different from the target Spec Standard value. For example, a specification may be 100% while a target may be 105% for a product formulated with a 5% overage. This represents the expected target value. See also the description of Spec Target value Standard. The highest value allowed that is in control. Values higher than this will Upper control limit produce a WARN status. The values may be set or based on SPC calculation. The highest value allowed that still meets the specification. Values higher Upper spec limit than this will produce a FAIL status. The highest value considered as a reasonable entry. Values higher than this Upper reasonable limit will prompt the user that this may not be a reasonable. This limit may prevent entry errors. [SOP Standard Operating Procedure SOP No | Rev C-108 0 Page 14 of 14 Redzone Administration Activities Attachment 2 — Redzone Triggers and Reactions Table 4: Triggers Trigger Type Description Shift Started The trigger will fire upon the start of a shift. Shift Ending The trigger will fire once the shift is ended. Shifeuntine rere an interval where the trigger will fire based on uptime during the Shift downtime Define an interval where the trigger will fire based on total downtime during the shift. Shift continuous Define an interval where the trigger will fire based on a period of continuous downtime downtime during the shift. ; ; Define an interval where the trigger will fire based on elapsed time during piso er sea ui the shift (regardless of uptime or downtime). ; , Define an interval where the trigger will fire based on the total number of Shift units produced ; .; units produced during the shift. Run started The trigger will fire upon the start of a run Run ending The trigger will fire once the run is ended. Run uptime Define an interval where the trigger will fire based on uptime during the run. Define an interval where the trigger will fire based on total downtime during Run downtime the run. Run continuous Define an interval where the trigger will fire based on a period of continuous downtime downtime during the run. Define an interval where the trigger will fire based on elapsed time during Run elapsed time the run (regardless of uptime or downtime). Define an interval where the trigger will fire based on the total number of Run units produced units produced during the run. Define a specific percentage of completion where the trigger will fire based Run percentage complete on the scheduled quantity of the run. Define an interval where the trigger will fire if the run is not signed off or Run sign off incomplete locked Datasheet completed Specify a datasheet and result that will trigger this data sheet to be created. Datemtcemplcted Trigger will fire based on the defined result of a specific data item on a datasheet. Can configure trigger to fire on a specific month, day of the month or week, Calendar and time of day. : Specify a start date/time, and define an interval for the trigger to fire Recurring regularly. Trigger will fire upon creation of a problem — based on Problem Type, Problem created Group, Category, or Asset. Trigger will fire based on the defined result of a cycle — can be based on Cycle update specific assets or products.