QUALITY & REGULATORY MANAGEMENT CONSULTING

Good procedures are hard to come by.

We can:

  • Write new procedures

  • Gap assess current procedures

  • Recommend improvements

  • Conduct work stream reviews (e.g. full NPD workflow)

Whether you are a start-up with very few procedures, or an established business with a web of historical processes, we can create or revise policies, procedures, and work instructions to get work flowing smoothly.

We review your documentation against applicable legislation, standards, and guidance to determine what you need to do. We also examine whether the currently defined responsibilities reflect real day-to-day practice.

The output is procedures, work instructions, and forms that feel lighter and enable accountability.

  • This is a common complaint. Procedures often evolve over time, with new sections being bolted on in response to audit findings, new products or personnel growth.

    We can provide the outside perspective to take procedures like this back to the drawing board. Some key questions are:

    • What is necessary to meet the requirements of the relevant laws, standards and guidance?

    • What is necessary to work with adjacent company processes?

    • What is necessary to ensure continued quality of the process output?

    • What is necessary to ensure people follow the procedure?

  • This can be tricky, originating from factors such as technology and systems change, lack of update to procedures, and poorly understood technical processes. In these cases, we would recommend forming a thorough understanding of the technicalities of a process first, then relating them to the relevant regulation in that area.

    It’s essential that real actions and processes are aligned. Not following your own processes is a fast way to receive audit findings, even if "the procedure is wrong”.

  • You need to analyse the root cause of why they are not following procedures, as a variety of causes could be at play:

    • Procedure written too vaguely

    • Procedure written highly prescriptively, not allowing for normal process variance

    • Too many, or too few, approvals

    • Unsuitable responsibilities defined in procedures

    • Procedure doesn’t define competency requirements for staff

    • (and many more possibilities…)

    We’re happy to help find the root cause, and implement optimised SOPs.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

BIO

“Insanity is doing the same thing over and over again and expecting different results.”

- Rita Mae Brown

QUESTIONS & ANSWERS

  • Absolutely. We’ll bring our experience of working across design, manufacturing, quality, and regulatory, to streamline your processes for the current regulatory environment.

  • It sounds like you’ve outgrown your current procedures. Our first step would be to recommend a framework of policies, procedures, and work instructions. We’d take what’s currently documented in your procedures and fit it into that new framework. Finally, we’d fill in the gaps by interviewing your teams that perform the actual work.

    All steps are underpinned by the requirements of relevant legislation, standards and guidance.

  • This can be a substantial growing pain. We can tailor a consultation to your precise needs, reviewing procedures and interviewing teams on both sides, prior to recommending and implementing harmonised solutions.

Want to make that QMS run leaner?

ENQUIRE NOW

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