How can you involve external experts in the review and improvement of SOPs in manufacturing operations?

To me going for and external expert, which in itself is an oxymoron, is a recognition of failure within the organisation. SOP’s are a fundamental building block and need to developed by those that know the process the best and that is those doing the job and it is up to the Company to develop and utilise those people accordingly. An outside “expert” will only sell you the framework or principles of an SOP, what they can’t give you is the current best method to the job that has to come from within. Once you go down this expensive route you are stuck with the no responsibility angle for the staff and also stuck with further expense when you want to change or update the process if you have no in house skills.

In my opinion... 1. Identify the areas of expertise: This could include technical knowledge, regulatory compliance, best practices, and industry standards. 2. Reach out to industry partners: Connect with other manufacturing companies, organizations, and professional networks to seek out recommendations for external experts. 3. Engage with consultants and advisors: Hire consultants and advisors with relevant industry experience and expertise in manufacturing operations. 4. Collaborate with academic institutions: Partner with research universities to involve professors and researchers who specialize in manufacturing operations. 5. Conduct external audits: Bring in external auditors to review your manufacturing operations and SOPs.

As long as the company relies on people with similar background and similar experience, it will need the support from external parties. This support might have a temporary benefit, but for the long run, diversity is needed not only to improve SOPs but also for countless reasons such as innovation, creativity, and streamlining of processes.

Engaging external experts in the review and enhancement of manufacturing SOPs is essential for fostering innovation and ensuring regulatory compliance. By leveraging the specialized knowledge and fresh perspectives of these experts, organizations can identify inefficiencies, mitigate risks, and streamline processes. Clear communication of objectives and transparent collaboration facilitate productive discussions and the exchange of best practices. Incorporating feedback from external experts into SOP revisions fosters a culture of continuous improvement, ultimately enhancing operational efficiency, quality, and safety standards.

If you cannot find the expertise within or you need regulatory guidance, reach out to external experts to ensure alignment of SOP with requirements. Aligning the SOP with requirements ensures quality vision and successful inspections.

SOP is a basic fabric of consistency in routine business activities. @initiation, it rarely NEEDS experts... except for providing effective 'proforma' for the SOP. PLUS keep it simple ('work-flow-sheet' with templates for the 'work-record-sheets' or simple check-sheets)... and about 60% of the work is done. This not only embeds the participation and ownership of the hands-on operative in the SOPs created... but is also org-wide & swift. Max, a week. Once these base documents are generated, the supervisors could sanitize them to standardise and infuse the desired 'operating standards'. The QSP team can then lay-over the DDC (Document & data Control) details. Expert intervention (typically IE), after this stage, is apt n productive.

Ensure there is a documented change control policy and procedures to justify and assess external expert selection. Have defined criteria within the procedure throughout the SOP review and improvement process. This ensures less re-work cost and alignment later.

Outside experts can evaluate your current condition, teach your people skills, and even show your people how your equipment should work and restore and improve that equipment. But I am with Peter Atkinson on this, developing and improving SOP’s is at the heart of a company’s way of doing business and can only be done effectively internally if you expect a company’s culture and success to survive in the long term (more than 3-5 years).

During the development of process,SOP is also parallely can be done. SOP includes all micro to macro activities,with 5 w&H(who, when, where,why, which and how many,how (method)etc). Also what are the monitoring points,data collection system, levels of supervision, QA validation checks etc. But what is the most important is SOP is developed and maintained by that process owner.

1.Decide to improve upon the area of weakness e.g. delay in completing jobs. 2. Analyse and choose the person to implement best methods. 3. Train the operators under the new person . 4. They should work under the guidance of the expert.

For a manufacturing process under development, the SOPs can be finalized only on successful validation of the process. Process monitoring method and frequency can be decided only on knowing the capability of the developed process, and not earlier than that.

Communication is key to working with experts successfully. Keep them informed of when the goals and objectives change so they can reassess and help you succeed.

Working with external experts is an assessment of a snapshot in time and not a one and done. This is part of the continuous improvement process and should be defined within the SOP.