When managing Quality/GMP, individuals in companies gain knowledge through formal training and on-the-job experience. Knowledge gained can be considered through 4 stages of learning:
- Unconscious incompetence
- Conscious incompetence
- Conscious competence
- Unconscious competence
Knowledge gained and retained on such matters within organisations establishes the level of Quality Management Maturity that we observe among clients we work with.
To illustrate, we take the example of Quality Agreements - showcasing how companies gain competency and quality management maturity, moving through these stages of learning.
Stage 1: Unconscious Incompetence
At this stage, companies are unaware of their lack of knowledge. Without recognising areas needing improvement, complacency can set in, resulting in a lack of motivation to change.
Progression to the next stage requires acknowledging these gaps in knowledge or skills.
A company establishing itself and tasked with preparing a Quality Agreement may have no prior experience or understanding of what is required. Following an off-the-shelf template SOP may suffice initially, but important details, such as specific responsibilities, might be overlooked.
Stage 2: Conscious Incompetence
At this stage, companies recognise their lack of knowledge. This awareness, though frustrating, is essential for learning and development. It is crucial to identify and accept weaknesses to take steps to improve.
For instance, an external auditor might highlight that while a Quality Agreement meets the intent of regulatory requirements, it lacks specifics, leaving roles and responsibilities unclear. This realisation marks a crucial step in understanding the true potential and intent of a Quality Agreement.
With managerial support, a review of existing Quality Agreements might reveal vagueness and lack of helpful detail, leading to significant improvements.
Some organisations may remain stuck at this stage, aware of their deficiencies, however not willing to invest to improve their current state.
Stage 3: Conscious Competence
At this stage, there is a sense of confidence and proficiency, but tasks still require focus and concentration.
Drafting and reviewing Quality Agreements demands conscious effort and attention to detail. By clearly defining requirements and expectations, Quality Agreements can drive quality requirements for the company or clients.
We’ve observed the following examples from the industry on situations where Quality Agreements have been improved, as clients attain this stage of maturity.
Example 1: A service provider that used to come on-site to perform some testing and certification provided a Certificate three weeks after testing that stated the equipment tested had failed. When asked why the client was not informed earlier, they said they told an employee they had seen in the facility and left after signing out with the receptionist. It was never identified who was told, or if they had told anyone as that important verbal communication had never been relayed to the Engineer or Quality departments. Since there was no issue reported the equipment had continued to be used during that time. The Quality Agreement between the client and the service provider was updated as follows:
Before:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
|
Report/Certificate to be provided. |
|
X |
Any failed testing must be notified. |
After:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
|
After completion of testing: |
|
X |
All OOS results to be communicated verbally to Engineer at time of testing. |
Example 2: For an IT services provider, the Quality Agreement stated they needed to inform the client of all changes. The provider argued they needed to constantly run version updates in the background. Several strategies were put in place to manage this provider. As a result, the Quality Agreement was updated. One of the improved clauses for this provider is shown below.
Before:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
|
All changes must be notified. |
|
X |
|
After:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
|
Proposed Change notification: |
|
X |
Proposed changes will need to be assessed by ‘Contract Giver’ prior to implementation. Changes that affect the performance or functionality of the system may require qualification prior to implementation. |
|
Notification of Changes |
X |
|
|
Example 3: A client was having trouble with one of their accredited laboratory service providers. Accreditation was not mandatory, but the client wanted to maintain service to the accreditation standards. An alternative provider was sourced who was not accredited for this service. They were audited and found to meet all the requirements and found to have better systems and processes in place than the current provider. Our client moved to the new provider. We identified that one of the things that may be impacted by this change would be that the laboratory report may not include all the information we required or were accustomed to seeing from our previous provider. The new provider would need the report requirements documented. Stating the information within the Quality Agreement clauses was the best way to proceed. The provider could then ensure the report they prepared met the requirements stated in the Agreement.
Before:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
|
Maintain ISO 17025 accreditation. |
|
X |
Inform Contract Giver if accreditation is cancelled. |
|
Provide Calibration certificate. |
|
X |
|
Some of the additions to the new Agreement after included:
|
Requirement |
Contract Giver |
Contract Acceptor |
Comments |
| Maintain systems and processes to meet the requirements of ISO 17025. | X | X |
Contract Acceptor does not hold ISO 17025 accreditation. Contract Giver accepts accreditation is not mandatory for the laboratory. Contract Acceptor will allow 2 site audits by Contract Giver per calendar year to verify compliance. |
| Verify Contract Acceptor meets the requirements (i.e. that of an ISO 17025 accredited laboratory). | X | ||
| Calibration certificate must contain following information: - A title (calibration certificate). - The name and the Address of the Calibration Laboratory. - Unique identification number of the calibration certificate and the pages until the last page of the calibration certificate (e.g. page 2 of 2). - The name and contact details of the customer. - Identification of the calibration method. - A description of the condition and identification of item calibrated. - The date of the receipt of the calibrated item and the date of the calibration. - The date of issue of the calibration certificate. - Calibration results and the unit of measurement. - The names, functions, and signature of persons authorizing calibration report. - A statement to the effect that the results relate only to the item calibrated. - Any additions, deviations or exclusions made during the calibration. - Deviation from the calibration method, and information on specific calibration conditions such as environmental conditions (e.g. limited calibration). |
X |
Stage 4: Unconscious Competence
The final stage of learning is like second nature. Companies have internalised their knowledge and skills to the point where tasks are performed effortlessly and automatically.
Achieving this stage consistently can be challenging as continuous learning and development are always necessary.
For instance, with the example of Quality Agreements, expertise in establishing and maintaining agreements can be claimed at this stage, however companies must remain vigilant in monitoring the effectiveness.
In summary, recognising one's position on the journey of Quality Management Maturity, through the lens of these 4 stages of learning, is essential for appreciating the areas that need to be invested in for continuous improvement.
SeerPharma has extensive industry experience in assessing the state of Quality Management Maturity amongst Pharmaceutical and Medical Device companies and assisting them on their journey towards reaching “Unconscious Competence”.
Contact Us to learn more and engage our services to support you with your Quality/GMP needs.
