GA Manufacturing Extension Partnership (GaMEP) Georgia Tech

The Do’s And Don’ts of Preparing A New Facility For The First Audit

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The Do’s And Don’ts of Preparing A New Facility For The First Audit

Starting a new facility is an enormous undertaking.  There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment.  This scenario is a perfect example of “Too much to do and not enough time to do it!”.  There’s always significant pressure to get up and running to start the return on the company’s enormous investment.  To further complicate the situation, most customers require one or more audits of the site’s Food Safety Quality (FSQ) System before the first sellable product can be produced on the line.  These qualifying assessments range from a casual, on-site visit by the customer to a Global Food Safety Initiative (GFSI) audit.

Meeting the ever-increasing standards of something as daunting as a full-blown GFSI audit can be an intimidating prospect, and success can only be achieved through strategic planning.  There is so much to be done to get the plant running before looming deadlines, which often leaves little time to prepare for initial audits.  This is a race against the clock, but success is possible through alignment, engagement, planning, and prioritization.

Get Everyone on the Same Page

The biggest pitfall of any quality leader is trying to execute all the audit preparations themselves or only relying on members of the Quality Department.  The key to avoiding this is to engage management and distribute audit preparation activities across different departments.  Before this can happen, a strategy, or Audit Preparation Plan, must be developed and agreed upon by all applicable stakeholders.   Upper management must be involved and aligned on the resources needed.  This process starts with an internal assessment of the audit requirements to understand where the gaps are and determine the best solutions.  Create a sensible timeline and have routine follow-up meetings to discuss progress and assign resources.  Make adjustments to the plan where needed and ensure that there is proper accountability for those responsible.

Another mistake is ignoring employees outside of upper management.  Understand who is going to be executing these programs and involve them from the start.  Sometimes the creation of effective systems isn’t as big a challenge as creating sustainable ones.  The best way to ensure that FSQ Systems will continue to operate smoothly comes from engaging the employees that carry out the day-to-day operations.  Gain buy-in from empowering them to take part in how quality tasks are monitored.  Simply asking advice about how worksheets should look or where to store tools can go a long way.  They are the ones that are going to take these newly-created programs and make them into a reality.

Dealing with Delays

If there is control over the audit date, ensure there is sufficient time for all the preparations.  Despite best efforts, sometimes things don’t go according to plan.  Meet with the management team and see if there are ways to makeup the time or shuffle resources.  It might be unavoidable that an unforeseen delay occurs and a deadline can’t be met.

If there hasn’t been enough time for the proper preparations, consider approaching the customer and asking for more time.  It doesn’t set a good precedent to continually push back an audit date, but it might be necessary.  This setback is usually a better choice than failing an audit or compromising the safety of your product.

This decision is just one more risk assessment to be done.  Consider all the variables and decide if a delay causes more damage than an unsatisfactory audit score.  Be transparent about progress to the management team, corporate officers, and applicable customers.  A little warning will make a possible delay more palatable.

Borrow with Pride

It’s imperative to leverage every asset.  Often, new plants have established sister plants with mature FSQ Systems already in place.  Borrowing templates, verbiage, and existing systems are all extremely smart ways to save time when developing these programs for a new site.  Remember that borrowed items must be carefully reviewed and tailored for that facility.  The type of product, workforce, equipment, customer and regulatory requirements must all be taken into consideration.  The best advice for starting a new facility is to never start from scratch unless that’s the only option.

There are a tremendous amount of resources out there.  University extension specialists are a wonderful support option for understanding and complying with applicable governmental regulations.  Trade and professional organizations are a well of knowledge and experience that can be tapped.  There are also experienced consultants that can aid in almost any step in this process.  Their services include creating HACCP (Hazard analysis and critical control points) and food safety plans, aiding with practice audits, training staff, and setting up specific programs.  Interns or temporary staff can also contribute to creating new programs.

Vendors like pest control companies, chemical suppliers and outside laboratories can be a surprising source of aid.  They are often a well of knowledge and have already prepared training, sometimes documentation that can be easily converted to meet the plant’s needs.  They have a vested interest in the plant’s success and will often go to great lengths to offer support.  It never hurts to ask.

Simplicity is the Key to Success

Quality leaders are often perfectionists, driven by the need to meet every requirement to the letter.  One of the biggest pitfalls that a new plant can fall into is over-complicating their FSQ Systems.  The harsh reality is that there isn’t always going to be enough time to do everything in the beginning.  Some items on the list might have to be delayed due to time constraints or unavailable resources.

Producing safe food in a workplace that is safe for every employee is always the starting point. Everything else can be prioritized from there.  Making a list of all the key tasks and required documentation and prioritizing it is the best way to ensure that the vital systems are in place.  For example, having a statistical process control system in place isn’t going to be as vital to operations as a fully implemented Food Safety HACCP Plan.  Determining the time and resources each task will take also needs to be considered in this prioritization planning.  Ensure that input is gathered from other departments and members of management.

These first few months will set the tone for a site’s developing food safety culture.  It’s important to be meticulous but not too rigid.  The best FSQ Systems evolve over time but always start with a solid base that is created by prioritizing what is truly important.  What has worked at one location might not work at another.  If the deadlines are looming too close, don’t be afraid to recruit aid in the form of colleagues, universities, vendors or consultants.  After the initial audit is complete, ensure that any corrective actions are established for any nonconformances identified.  Share the results, not only with those that aided in audit preparations but all associates at the site.  Celebrate the wins and learn from the losses together to build a stronger team for the future.

By: Wendy White, Industry Manager, Food Safety and Quality, Georgia Manufacturing Extension Partnership

How to Avoid the 10 Biggest Quality Mistakes

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How to Avoid the 10 Biggest Quality Mistakes

Learning from other people’s mistakes is one of the most effective ways to improve. There are plenty of mistakes out there to learn from, but the trick is to recognize them and understand what to do instead. Let’s examine the 10 most common quality mistakes and see how they can be corrected.

1. Limiting quality objectives to traditional quality topics

Quality is reflected in everything your organization does, and a quality objective can be anything measurable that relates to your organization’s success. A quality objective might relate to finances, customer feedback, safety, efficiency, speed or innovation. All these attributes relate to quality in one way or another. When selecting quality objectives, it’s important that your organization examines what matters most to its success. Whether the resulting measure is tied to traditional quality control or quality assurance is irrelevant.

2. Holding infrequent management reviews

Management review is the process by which top management analyzes data, makes decisions and takes action. Ideally, it’s a preventive process because data should indicate developing threats before they blossom into full-blown problems. Top managers should be able to analyze data proactively to prevent problems. Holding management reviews frequently allows you to review real-time data so that actions can be preventive. If these meetings are held only once or twice a year, however, you will not get the information that is necessary to make important decisions for your company’s success.

3. Sending out long, complex customer surveys

Instead of a survey, why not simply ask your customers what they like and dislike? Don’t limit their responses to survey topics. Let your customers dictate the content of their feedback in response to open-ended questions. Few questions are more powerful than the following: What do you like? What don’t you like? What would you like to see different in the future? Open-ended feedback is also much easier to understand and take action on. A customer-satisfaction index of 3.8 is hard to interpret. On the other hand, seven out of 10 customers telling you that your Web site is confusing and pinpointing what makes it confusing provides a clearer path to improvement.

4. Assuming everyone knows what “nonconforming” looks like

When I visit organizations, one of my favorite questions is, “Where do you put the nonconforming products?” Control of nonconforming products is one of the most basic kinds of controls, and it speaks volumes about the rest of the controls embraced by the organization. Smart organizations positively identify all nonconforming products, and really smart organizations segregate them to remove all chance of accidental use. Error-proof your control of the nonconforming product process so that assumptions don’t have to be made.

5. Failing to use the corrective action process

Corrective action is the systematic way to investigate problems, identify their causes and keep the problems from happening again. Nobody wants problems, but it’s essential to have a way to deal with them when they come up. The more the corrective action process is used, the better the organization gets at addressing its risks and problems. An effective corrective action process is typically seamless, simple and intuitive. Actions developed correctly add a little structure to problem solving and don’t create additional bureaucracy.

6. Applying document control only to official documents

Most organizations do a decent job of controlling “official” documents: the procedures and work instructions that form the core of the quality management system (QMS). These are often written, approved and issued according to very specific guidelines. What organizations don’t do very well is control unofficial documents, many of which are more important than the official ones. These may be memos that include procedural steps, Post-it Notes with special requirements, emails with customer specifications, and many others. These informal resources become documents when they’re shared for people to use, and they’re some of the most important documents within an organization. Apply document control to all documents, and scrutinize your document control process to keep it streamlined and effective.

7. Focusing audits on petty, nonstrategic details

Auditing is the process of comparing actual operations against commitments the organization has made. It’s a simple, fact-driven process that can generate huge improvements. However, these improvements happen only if auditors focus on the right things. Too often, internal auditors become preoccupied with petty details and neglect the big issues. They’re uncomfortable examining the big, strategic issues. It’s important for your organization to provide training and skill-building to your internal auditors to avoid these common pitfalls.

8. Training some personnel, but not all

Most organizations provide significant training to hourly production personnel. Salaried and managerial personnel are often neglected, however. Why? Because there’s a perception that salaried workers don’t affect product conformity. This is a serious error. All personnel must be included in the training process. Salaried and managerial personnel need more—not less—training because their decisions and actions have larger and more lasting effects. When an hourly employee makes a mistake, it could cost money. When a top manager makes a mistake, it could put you out of business. Train your employees early and often.

9. Doing anything just because an external auditor told you to

In my travels to companies, I often ask people why they’re carrying out a process the way they are. I always raise this question when the process seems unwieldy or illogical. In a surprising number of cases, the answer will be, “Because the external auditor said we should do it that way.” Before you jump into any recommendation, conduct a reality check to make sure it makes sense for your organization.

10. Employing someone who only oversees the QMS

Having a person who does nothing but oversee the ISO 9001 (or any other) QMS is not a good
idea as it guarantees two things:

  • First, the QMS coordinator will become isolated from the rest of the organization.
    Because the person does nothing but serve the QMS, he or she loses touch with why
    the organization exists and what the organization’s objectives are. The system becomes
    paramount over the organization’s business concerns.
  • Second, the QMS will become bloated and bureaucratic because it must expand to
    completely fill someone’s time. Procedures become more complicated, methods more
    cumbersome and the benefits more ambiguous.

A quality management system needs to be a streamlined and simple engine for success. Instead of being an adjunct to the way an organization conducts business, it needs to be The Way business is conducted. Weave the system into the day-to-day flow of activities and watch it produce results.

And by all means learn from the mistakes of others.

By: Craig Cochran, Project Manager, Georgia Manufacturing Extension Partnership