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So the Validation Department generate the protocol and the Quality Department are involved in reviewing the protocol. Having worked on various different projects it has become quite apparent that the quality review on any protocol is a very important review as it irons out all of the documentation mistakes that occur when the document is being generated.

Quality Vs Validation  - Good Vs Evil
Quality Vs Validation - Good Vs Evil

On the other hand I often wonder if quality takes this review too far, and if they do why?

Quality Review

For example if you have a quality person reviewing an IQ or OQ protocol on a computer application, is it acceptable for them to review it having little knowledge of the application.

Does this lead to the quality person reviewing the protocol with an overly cautious approach to the point where the validation engineer is ready to pull their hair out in frustration.

A Simple Scenario

Lets take a very simple scenario. A test protocol usually has the following fields:

  • Test Procedure
  • Acceptance criteria
  • Meets Acceptance Criteria Yes/No
  • Performed by /Date

The column to take note of in this scenario is the Acceptance Criteria and the Performed by/Date field.

Lets discuss the acceptance criteria field first, this field usually contains the criteria that must be met in order to pass a test section. If the test is carried out and the acceptance criteria are not met then this usually results in a deviation or an event being raised.

I don’t think anyone has an issue with this scenario, but in terms of acceptance criteria what is acceptable?

Let take a simple example:

Test Procedure: Click the Yes radio button
Acceptance Criteria: Deviation message is displayed
Meets acceptance criteria: Yes
Performed by: Joe Soap 12/12/09

Is this acceptable from a quality perspective though, I mean when you sign the performed by section do you mean that the test has been completed or do you mean that the deviation message was displayed and the test was completed.

Screenshots

If the quality department are not happy with the latter then they will require a screenshot as evidence that the deviation message was displayed.

Do you see what I am getting at here; does this mean that screenshots are required for all acceptance criteria?

If so then your protocol will contain numerous attachments and a long review time.

Before your protocol is approved you really need to work closely with the quality department in order to understand what is acceptable from an acceptance criteria view point.

If you would like further assistance with protocol generation please feel free to contact Premier Validation

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  • maryacton

    Nice post – Yes we have the same issues with quality, they are important to the overall process but it is important that validation and quality work together and not think they are on different teams.

  • maryacton

    Nice post – Yes we have the same issues with quality, they are important to the overall process but it is important that validation and quality work together and not think they are on different teams.

  • S. J. D’Souza

    Documentation corrections do not equal spelling mistakes. There is more to a quality review that just spell check. On the surface it seems so much easier to have to review a document than having to create it in the first place. Having to write a protocol for anyone to understand decreases the efficiencies of the risk based approach or quality by design. IMHO it is incumbent of the quality approver to educate him/herself of the application in question before/while approving. Approval should be an iterative process to deliver the best qualification document.

  • S. J. D’Souza

    Documentation corrections do not equal spelling mistakes. There is more to a quality review that just spell check. On the surface it seems so much easier to have to review a document than having to create it in the first place. Having to write a protocol for anyone to understand decreases the efficiencies of the risk based approach or quality by design. IMHO it is incumbent of the quality approver to educate him/herself of the application in question before/while approving. Approval should be an iterative process to deliver the best qualification document.

  • gokeeffe

    Hi S. J. D’Souza,

    Thanks for the comments, in your experience could you provide a list of other aspects of a quality review?

    Cheers

    Graham

  • gokeeffe

    Hi S. J. D’Souza,

    Thanks for the comments, in your experience could you provide a list of other aspects of a quality review?

    Cheers

    Graham

  • snaranjo

    Quality involvement on Computer validation is essential to success, but also to concentrate on relevant testing and documentation. We can take tons of screenshots as evidence of standard functionalities (hardly tested by the supplier) and miss the opportunity to test critical or risky configuration. Then we have a very nice but useless documentation. In other words, validation effort should be focussed on demonstrating that system (or system configurations) meet the user processes without compromising electronic records. Documentation is a part, not the goal of validation, and quality people not always has this view. In my opinion, testing must be done by a well-trained or experienced user who write “pass/not pass” and sign the execution. A second user (witness or not) review the results and take part on resolution of fails/non conformities. We use to involve QA as final test reviewer (and protocol/report approvers).

    Regards

  • snaranjo

    Quality involvement on Computer validation is essential to success, but also to concentrate on relevant testing and documentation. We can take tons of screenshots as evidence of standard functionalities (hardly tested by the supplier) and miss the opportunity to test critical or risky configuration. Then we have a very nice but useless documentation. In other words, validation effort should be focussed on demonstrating that system (or system configurations) meet the user processes without compromising electronic records. Documentation is a part, not the goal of validation, and quality people not always has this view. In my opinion, testing must be done by a well-trained or experienced user who write “pass/not pass” and sign the execution. A second user (witness or not) review the results and take part on resolution of fails/non conformities. We use to involve QA as final test reviewer (and protocol/report approvers).

    Regards

  • http://www.validationplusinc.com jeff gassman

    Several interesting points should be clarified:

    1) prior to writing a protocol, I recommend that a team be established including the writer, the system owner, and the quality reviewer. This allows the team members to learn their strengths, weaknesses, and personality traits (if the quality reviewer is weak in computer validation the others can diplomatically provide suggestions, learn that the quality reviewer is not open to suggestions, or learn what the quality reviewer expects). Having written over a hundred protocols, I highly recommend this.

    2) prior to writing a protocol, I recommend that the writer generate an outline of what will be tested and identify the template to be used (to achieve team consensus). For example, I recommend that you include columns for “Expected Results” and “Actual Results” so that the reviewer can determine if actual results met expected results.

    3) getting to know the team members before writing the protocol improves the likelihood of it being right-first-time (minimizing protocol approval time and protocol review time after execution).

    4) it is important that a protocol be written such that execution and review is not open to interpretation (the team, including the executor, knows what is expected as does the reviewer). As an example, state when a screenshot is required (attach printout demonstrating that ….). Screenshots are required to demonstrate tasks have been performed successfully. As a rule of thumb, one or two, per test case.

    If you have any questions, you can reach me via email at: jeffreygassman@validationplusinc.com

  • http://www.validationplusinc.com jeff gassman

    Several interesting points should be clarified:

    1) prior to writing a protocol, I recommend that a team be established including the writer, the system owner, and the quality reviewer. This allows the team members to learn their strengths, weaknesses, and personality traits (if the quality reviewer is weak in computer validation the others can diplomatically provide suggestions, learn that the quality reviewer is not open to suggestions, or learn what the quality reviewer expects). Having written over a hundred protocols, I highly recommend this.

    2) prior to writing a protocol, I recommend that the writer generate an outline of what will be tested and identify the template to be used (to achieve team consensus). For example, I recommend that you include columns for “Expected Results” and “Actual Results” so that the reviewer can determine if actual results met expected results.

    3) getting to know the team members before writing the protocol improves the likelihood of it being right-first-time (minimizing protocol approval time and protocol review time after execution).

    4) it is important that a protocol be written such that execution and review is not open to interpretation (the team, including the executor, knows what is expected as does the reviewer). As an example, state when a screenshot is required (attach printout demonstrating that ….). Screenshots are required to demonstrate tasks have been performed successfully. As a rule of thumb, one or two, per test case.

    If you have any questions, you can reach me via email at: jeffreygassman@validationplusinc.com

  • http://etech-group.com/index.php?page=ServicesWeProvide&textsec=8 Validation Specialist

    Excellent comments – particularly the detail from Jeff.

    Something to keep in mind is that there are several common rationales or approaches to validation. These can typically vary by company, by division within a company, or even by the project that you are representing. Understanding the validation approach for your particular project is critical if you expect to be successful when it comes time for a quality review. Deliverable types that were acceptable on your last project may no longer apply, even for the same type of system.

    For example, if your project follows a risk-based approach there will be specific criteria that quality uses as a measuring stick. You may have a full suite of system lifecycle documentation, such as User Requirements, Functional Specifications, and/or a Design Specification of some sort. Depending on how the risk-based approach is structured, quality may expect your protocol to include verifications of specific elements from within these lifecycle documents. Your role in a project may be focused on protocol development, however, it’s critical that you understand validation rationales that may already be planned for your project. This is in alignment with comments by Jeff that you should familiarize yourself with quality’s expectations.

    To summarize, while it’s crucial that protocols and test cases be structured in a manner that eliminates ambiguity, understanding the rationales for testing and the appropriate deliverables that feed into the qualification effort are foundational when it comes time for a quality review.

    As a caveat, there are clearly organizations who don’t require indepth planning or advanced rationales when planning a validation effort. Whereas understanding a risk-based approach to protocol writing is critical if you want to be successful in a risk-based environment, communication of expectations is equally critical in a less rigorous business environment. In either case, the key to successful protocol development is understanding the basis that quality will be using when it’s time to review your work.

  • http://etech-group.com/index.php?page=ServicesWeProvide&textsec=8 Validation Specialist

    Excellent comments – particularly the detail from Jeff.

    Something to keep in mind is that there are several common rationales or approaches to validation. These can typically vary by company, by division within a company, or even by the project that you are representing. Understanding the validation approach for your particular project is critical if you expect to be successful when it comes time for a quality review. Deliverable types that were acceptable on your last project may no longer apply, even for the same type of system.

    For example, if your project follows a risk-based approach there will be specific criteria that quality uses as a measuring stick. You may have a full suite of system lifecycle documentation, such as User Requirements, Functional Specifications, and/or a Design Specification of some sort. Depending on how the risk-based approach is structured, quality may expect your protocol to include verifications of specific elements from within these lifecycle documents. Your role in a project may be focused on protocol development, however, it’s critical that you understand validation rationales that may already be planned for your project. This is in alignment with comments by Jeff that you should familiarize yourself with quality’s expectations.

    To summarize, while it’s crucial that protocols and test cases be structured in a manner that eliminates ambiguity, understanding the rationales for testing and the appropriate deliverables that feed into the qualification effort are foundational when it comes time for a quality review.

    As a caveat, there are clearly organizations who don’t require indepth planning or advanced rationales when planning a validation effort. Whereas understanding a risk-based approach to protocol writing is critical if you want to be successful in a risk-based environment, communication of expectations is equally critical in a less rigorous business environment. In either case, the key to successful protocol development is understanding the basis that quality will be using when it’s time to review your work.

  • waynem

    Nice Post! As I work for a large company with many branches, I have had to work closely with the various Responsible Head of Quality. My experience has shown that one has to understand the Quality “Person” to be able to understand their individual needs. Some are more prone to checking the basic fundimentals such as the font,size, shades of grey, etc of the documentation while others are extremely stroppy with spelling and grammer and yet have no idea of the various tests that are to be performed. Others ignore this and show a keen interest in the why, when, and what’s of the script that one is bombarded with so many questions that one starts to question your own protocol writing skills!! lol.

    As every person has a different outlook/way of doing something such as protocols, as a Protocol writer/executioner (grin..) at least ones life will never be boring.

    Keep the posts rolling. Tx

  • waynem

    Nice Post! As I work for a large company with many branches, I have had to work closely with the various Responsible Head of Quality. My experience has shown that one has to understand the Quality “Person” to be able to understand their individual needs. Some are more prone to checking the basic fundimentals such as the font,size, shades of grey, etc of the documentation while others are extremely stroppy with spelling and grammer and yet have no idea of the various tests that are to be performed. Others ignore this and show a keen interest in the why, when, and what’s of the script that one is bombarded with so many questions that one starts to question your own protocol writing skills!! lol.

    As every person has a different outlook/way of doing something such as protocols, as a Protocol writer/executioner (grin..) at least ones life will never be boring.

    Keep the posts rolling. Tx

  • R Hess

    Interesting that there seems to be such animosity between validation teams and quality teams. I work for a very small company and the quality and validation duties overlap as far as responsible personnel.
    I have had to do much educating here on what the purpose of validations are in order to be able to work well with all departments. And truthfully, the manufacturing departments are the most resistant to performing validations.
    Maybe this is a strange question, but don’t validation teams want their documents to meet all of the quality standards too? If a question the quality reviewer brings up cannot be answered easily, then maybe the quality reviewer has a point…?
    In our company, the quality department handles most of the external audits and must assist in defending documents to customers, ISO auditors, and government auditors. As both a quality and validation position, I definetly don’t want to be caught in a position with an auditor of any kind where I cannot defend or explain any part of a validation document…

  • R Hess

    Interesting that there seems to be such animosity between validation teams and quality teams. I work for a very small company and the quality and validation duties overlap as far as responsible personnel.
    I have had to do much educating here on what the purpose of validations are in order to be able to work well with all departments. And truthfully, the manufacturing departments are the most resistant to performing validations.
    Maybe this is a strange question, but don’t validation teams want their documents to meet all of the quality standards too? If a question the quality reviewer brings up cannot be answered easily, then maybe the quality reviewer has a point…?
    In our company, the quality department handles most of the external audits and must assist in defending documents to customers, ISO auditors, and government auditors. As both a quality and validation position, I definetly don’t want to be caught in a position with an auditor of any kind where I cannot defend or explain any part of a validation document…

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Training of personnel on deviation reporting and deviation handling is essential to a successful implementation of deviation management. All personnel must have a clear understanding of the deviation concept on all level of operation.

From a cleaning employee to a top level manager, everyone in the organization must apply deviation management procedure or instructions.

In order to do that, it must be mandated that all employee will attend at least once per year training on how to identify and report deviations.

 

The Three Levels

It is important to keep record of all the training’s performed in order to demonstrate to auditors that all personnel in the organization are competent and can report, handle, and/or manage deviations in a swift and accurate manner.

There are three levels of training on deviation management:

  1. Level 1: Identifying deviations and reporting them
  2. Level 2: Deviation Handling and Investigating
  3. Level 3: Deviation’s Corrective and Preventive Action

Level 1: Identifying Deviations and Reporting Them

  • This level of training should be mandated for all employees.
  • In this level, the trainee must learn how to notice and identify a course of actions or results which might indicate that something deviated from the standard and approved procedures in the quality management system.
  • This particular skill is crucial to the deviation reporting.
  • The trainer must spend considerable time developing attention to details in trainees. This particular competency forms the basis on which the trainer will build the trainees knowledge of deviation management.
  • The second obstacle to overcome is to make the employees understand that deviation reporting isn’t the equivalent of mistakes reporting.
  • In my experience, at first, many employees will see deviations as a way for the top management to record their mistakes for performance evaluation and bonus estimation.
  • The trainer must explain that it is the opposite of that concept, deviation reporting is your chance to express your interest in preserving the quality of the product or the service you provide in your organization.
  • It asserts your loyalty to the a quality based product and/or service and your devotion to the company’s standards.
  • Level 2: Deviation Handling and Investigating

    • This level of training is exclusive for management staff, including both lower and upper management.
    • In this level of training, the trainer must focus on investigational techniques and root cause analysis.
    • The basis of the training is risk analysis. The trainer must be an expert in risk identification, assessment, evaluation, reduction, and communication.
    • Other essential techniques include listening skills, communication, team work, and meeting management. These skills must be honed by the trainees during the training and during normal working hours.
    • The trainer must emphasis that this level of training is a mere introduction into deviation handling and that practice makes perfect. The reason is no one can develop all the skills necessary for investigating and solving complex deviations in one training module. The experience of the person practicing those tasks is the ammunition that would help him or her succeed at his or her job.

    Level 3: Deviation’s Corrective and Preventive Action

    • This level of training is exclusive to quality assurance personnel and upper management (including other department’s managers).
    • The aim of this training is to develop the ability of trainees to find the most efficient and effective actions to correct and prevent the deviation from reoccurring.
    • As we mentioned in 3.1.8. there are several points to consider when taking corrective and preventive actions. These points must be included in the training.
    • The trainer can be someone with experience with the applied procedure for corrective and preventive action in the organization and it would be better if he or she is experienced in risk management as mentioned in level 2 training.
    • If the training is being conducted for the first or second time, the trainer must emphasis to upper management that the trainee will need time to develop the experience necessary for them to create systematic actions with little to no side effects.
    • This training must conclude that the personnel required to decide the corrective and preventive actions must convene periodically in order to discuss the effectiveness of their actions and see what they can improve in their decision approach.

    Optional Training Sessions

    There are several competencies which are essential to successful deviation management, time management is one, communication management is also an essential feature which is greatly needed for the continuous and effective follow-up of deviations throughout the organization.

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