How can you improve your SOPs for quality control and inspection?

Quality control and inspection should not be separate activity and it should be part of manufacturing process. SOPs for manufacturing process should have interlock of PFMEA and control plan. Action plan of your control plan for arresting failures identified in PFMEA are key tasks in manufacturing process SOPs. Operator performing Processes as per SOP should be integral part of PFMEA and Control plan preparation. SOPs should be prepared with concept that defect should not pass from one process to another.

SOPs can be improved through reviews incorporating new regulatory requirements, best practices, and audit results. SOPs become an essential tool for the proper functioning of organizations and the compliance and sustainability of the quality management system. The SOPs must be a reflection of the activities and followed in a standard manner by collaborators, which is achieved through training and the definition of clear procedures attached to practices.

Quality Control and Inspection SOPs undergo Risk Evaluation, Validation, Implementation, employee Training and Audit. Once validated, any deficiency in these SOPs should be considered a Non-Conformity. Given that such an identified Non-Conformity would be linked to an SOP, it’s likely to be systemic and thus will qualify for a Corrective and Preventive Action (CAPA).

To make a Standard Operating Procedure (SOP) realistic and beneficial in quality control, follow these guidelines: 1. Clear and Specific Instructions: Ensure that the SOP provides clear, step-by-step instructions for each task, leaving no room for ambiguity. 2. Realistic and Feasible Procedures: 3. Input from Subject Matter Experts 4. Document Best Practices 5. Regular Review and Updates 6. Training and Education: SOPs should be a part of employee training. 7.Identify potential risks and challenges within your quality control processes 8. Compliance with Regulations 9. Use of Visual Aids 10. Include Performance Metrics 11. Test and Validate: Before finalizing the SOP 12. Accessibility 13. Continuous Improvement

Before approval of the SOP: For any instrument or procedure make sure to write down the stepwise directions to follow by using practically that particular procedure or instrument. Use supporting manuals, documentation, and certificate for the instrument's SOP preparation. Make sure to add Calibration and PM procedure including frequency, if the SOP is related to the instrument or equipment. And for the procedures using ICH or FDA guidelines as a reference. If the SOP is related to procedure then make sure to check the previous Incidents or deviations involved as well taken CAPA for those incidents and deviations. Make sure to SOP is reviewed by user to authorized person before it getting approved.

I see a number of SOPs that try to do too many things at once, they become long and complex and not relevant for all the teams that need to train in them. Simplification and ensuring the SOP is targeted to minimal teams at once allow for ease of understanding, training and compliance.

The data you'll be utilizing to determine the efficency of your SOP's will vary based on their area of applicability. For globally applicable procedures the most likely sources will be audit results (internal, external, regulatory), but this approach is very reactive and a more proactive approach can be benficial, like an easy way for the user's of the SOP's to submit feeback and improvement suggestions for considerations. Local, more product/process specific SOP's, can be improvement reactively by loking at relevant metrics such as failure rates per process, defect types, to determine where are actual improvents required. In many cases accetance criteria are vaguely defined that it leads to false positives, due to lack of understanding.

SOPs ensure streamedline operations with clear fundamental framework. However, I see the necessity to revise SOPs from the dynamic nature of the manufacturing industry, which demands constant adaptation to new technologies, market trends, and customer expectations. Regular evaluation and modification of SOPs is very important and allow businesses to address inefficiencies, incorporate innovative practices, and ensure compliance with evolving regulatory standards. By periodically reviewing SOPs, organizations can foster a culture of agility and continuous improvement, thereby enhancing operational efficiency and maintaining a competitive edge in the industry.

Something I've found to be quite helpful from my past experiences: a well written SOP should not only facilitate ease of comprehension by trained departmental staff already familiar with the related practices, but should theoretically allow even an uninitiated reader to be able to comply with the relevant standards and instructions; as such, apart from immersing myself in the SOP's target department and duties firsthand, at times I also find it helpful to cross-delegate personnel from unrelated functions in order to test the readability from a more impartial and fresh perspective. Multi-disciplinary collaborations like these will also at times help spark inspiration or innovations that would otherwise have been missed, causing stagnation.

In my experience, the SOPs should be a pack of knowledge of multiple areas within the boundary of an instrument/process. Stepwise description of the function/s with necessary pictures should be included. If needed, in a diverse environment, include translated versions of the SOP as well. Some of the important parts of the process which have direct or indirect impact on the final outcome, must be defined in the SOP e.g. - Expert/Authorized Engineer contact details - Process flow diagram - Tidiness instructions (which kinds of cleaning agents can be used) - Safety instructions (safe handling, waste collection points etc) - Utility functions guidance - Troubleshooting history as annexation

I really trust the training process and ofcourse there are solid reasons for that.. - The improvement in the quality of the output from the associates - The uniformity of the work across all associates - It gives ownership and empowerment to the associates

By following guidelines developed by training , one can create or update SOPs that are highly effective in guiding quality control and inspection processes within your organization while ensuring clarity, precision, and relevance.

SOP is a continuous process documents written with clear instructions for everyone to follow and keep process consistent to assure quality outcomes.

Provide comprehensive training to employees on SOPs for quality control and inspection. Ensure that they understand the procedures, rationale behind them, and the importance of adhering to SOPs for maintaining product quality and safety.

Procedure should be as per the actual practices and in line with the process requirements. Steps defined should be in chronology, simpler and easier for each individual to understand. There should be thorough periodic review. Should provide support, tools and sufficient resources to the doer. Regular trainings of the operators, their understanding and challenges on procedure shall be taken care and mitigated.

In order to check their implementation status, also need to question the operator about the SOP itself. If anything does not work accordingly, ask the operator its possible to improve the content and then update accordingly.

Para implementar eficazmente Procedimentos Operacionais Padr?o (POPs) nas opera??es diárias e integrá-los à cultura de qualidade, é crucial comunicar claramente sua importancia para a equipe. Treinamentos regulares e refor?o da conformidade s?o essenciais, incentivando o seguimento consistente dos POPs. Fornecer ferramentas e recursos adequados, juntamente com um sistema de suporte para relatar problemas e sugerir melhorias, é fundamental. A revis?o periódica e atualiza??o dos POPs garante que estejam alinhados com as melhores práticas e requisitos do cliente. Integrar a execu??o dos POPs à rotina diária, incentivando a autoavalia??o, ajuda a torná-los parte integrante das responsabilidades diárias da equipe.

By following guiding steps, one can successfully integrate their SOPs into their daily operations and foster a culture of quality and consistency within their organization. Regular review and adaptation to changes will help your SOPs remain relevant and effective over time.

Compare SOP content and actual practice along with Necessary Precautions. Each and every Step is to be defined in an easy to understand language along with its importance and precautions. Reparcations/ failure to follow the process flow should also be clear to the doer.

1.Make sure your SOPs are crystal clear. Use simple language and avoid jargon 2. A picture is worth a thousand words. Add diagrams or photos to your SOPs. 3. Speak your team's language. SOPs in the local language ensure everyone understands and follows them accurately 4. Display SOPs at the right spots where they're needed most. 5.Break down each task into smaller, easy-to-follow steps. 6.Clearly define who's responsible for what. Knowing who does what helps prevent confusion and ensures accountability. 7.Ensure your SOPs cover all product fit, form, and functional requirements. 8.Include guidelines for handling non-conformities and abnormalities. 9.Regularly review & update SOPs to keep pace with changing processes

Adding to existing contributions, user involvement is key to adoption, in my experience technical departments can create an SOP which is not reflective of how things are actually being done in sequence and can end up creating a book without considering time pressures. Critical information needs to be at the forefront without having to read pages & pages to try and find it. Another aspect is the diversity of people and languages, it would be difficult to create SOPS and maintain them in many languages. Using signs and symbols and as little text as possible overcomes language hurdles.

The aim of measuring and improving SOP outcomes is to ensure that they consistently deliver the desired quality, efficiency, and value to your customers and stakeholders. Regular assessment and refinement of SOPs are essential for achieving and maintaining high standards of quality control and inspection in your organization.

Todo processo pode e deve ser otimizado constantemente. Sabendo disso, para que possa ser feita mudan?as nos procedimentos é necessário ir ao gemba, acompanhar as atividades de perto, comparar o que está de acordo ou n?o com os POP's atuais para ent?o analisar o que é válido mudar ou melhorar.

Establish a process for regularly reviewing and updating SOPs based on feedback, changes in processes or equipment, lessons learned from deviations or non-conformances, and evolving regulatory requirements.

In my experience, SOPs should be worded and structured so that a user with little experience on the subject can still follow along with little to no outside assistance. While a level of flexibility is often required, SOPs should avoid ambiguous wording like “may, might, should, would” etc whenever possible. The argument against this often revolves around the deviations that strict wording would cause. The counter argument is that procedures are developed to operate a certain way for a reason and we cannot be compromising quality just to keep the number of deviations down. If an SOP requires ambiguity purely to avoid deviations then an investigation is needed into the testing process itself and the training of the staff performing it.

Reviewing SOPs is a continuous improvement practices. In my experience if you review your SOPs too often for example every two weeks, that means something is wrong with your operations or processes. You need to sit down with all the stakeholders involved with that procedure to define something that is more practical. It could be that procedure is too complex or too simple or not well understood.

SOPs shall have all the Product fit/form/functional requirements. It also should cover the PTDB (Past trouble data base) including internal or external concerns, Changes in the product/process level, FMEA review process outcomes etc. Following are few important points to make the SOPs more effective: 1) Standardize the SOP/Checklist templates 2) Pictorial representation will help for easy understanding 3) Cover all the product Fit/Form/Function level requirements 4) Have NC/Abnormality handling process in it 5) Have a revisit/review mechanism for any changes/complaints 6) Maintain the revision history and follow the Doc. change management process 7) Ensure the alignment of these SOPs with PFD, PFMEA, Control plan & Special characteristics.

Ideally there will be an SOP governing the preparation, approval, administration and periodic review of SOPs. That SOP is one of the most important SOPs in the Quality Management System because it helps control the quality of all SOPs.

Based on my experience, two points are to be considered: 1. Involving staff who regularly use the SOPs is critical to continuous improvement. Periodically analyze the feedback collected to identify common themes and areas for improvement. Develop action plans to address this feedback and communicate the planned changes to employees to demonstrate that their input is valued and taken seriously 2. Pilot phase: Before finalizing SOP changes, conduct a pilot phase using a risk-based approach. This involves monitoring, evaluating, and refining the changes based on real-world data. Establish a feedback loop that allows for continuous feedback from those involved in the pilot, allowing for real-time adjustments to the SOP as needed